Abstract
Self-management can mitigate common foot problems; however, community-dwelling older adults without diabetes rarely receive foot care self-management training. This two-group pilot study examined feasibility and preliminary efficacy of the novel, nurse-led 2 Feet 4 Life intervention. Twenty-nine adults (M age 76 ± 6.6 years) from two senior centers completed the study (90.6% retention rate). Intervention dosage was one hour/week for four consecutive weeks. Study procedures were safe and feasible. Intervention group participants found the intervention acceptable and valuable. Observed between-group effect sizes were: knowledge (4.339), self-efficacy (3.652), behaviors (3.403), pain (0.375) and foot health (0.376). Large effect sizes were observed within-groups and within their interaction for knowledge (1.316), behaviors (8.430), pain (9.796), and foot health (3.778). Effect sizes suggest the intervention impacted foot care outcomes between groups and within individuals over seven months’ time. Fully-powered studies are indicated to test the intervention in diverse samples with more complex foot problems.
Keywords: self-management, self-care, foot care, older adults
Foot problems are common in adults; however, they are of particular concern in older adults (Awale et al., 2017; Institute for Preventative Foot Health, 2012). Simple foot care problems (e.g., corns, calluses, long, jagged, thick nails) can be addressed with proper self-management, but older adults may lack the knowledge, skills and supplies to do so (Miikkola et al., 2019; Stolt et al., 2012; Waxman et al., 2003). Although clinic-based foot care self-management interventions for persons with diabetes mellitus have been shown to increase foot care behaviors, knowledge, and self-efficacy, while improving foot pain and foot health (Baba et al., 2015; Fan et al., 2013; I. C. Williams et al., 2014), little is known about the feasibility and efficacy of nurse-led foot care self-management interventions in community-dwelling older adults without diabetes. Given the expected increase of the older adult population to 98 million by 2060 (United States Census Bureau, 2017), the prevalence of foot problems will increase over time.
Foot Health and Self-Management
Foot problems in older adults can cause pain, impair foot function and mobility, increase risk for falls, and may even lead to hospitalization (Awale et al., 2017; Lazzarini et al., 2016; Menz et al., 2013). Even in older adults without diabetes, minor foot problems can become major issues (e.g. athlete’s foot infections, cellulitis, ingrown toenails), if ignored (Campbell, 2007). However, many older adults do not seek health care services when foot problems occur (Miikkola et al., 2019). Reasons for a lack of treatment include limited healthcare access, failure of primary care provider to assess foot health, inadequate understanding of treatment options, and/or simply ignoring their feet (; Wilson et al., 2017).
Extant foot care self-management literature has focused almost entirely on populations with diabetes. Foot care self-management is generally presented as a small part of overall diabetes management programs. Although some diabetic foot care self-management programs were presented in a stand-alone format, they were based in outpatient clinics, rather than community settings (Baba et al., 2015; ; Fan et al., 2013; Keller-Senn et al., 2015; Lincoln et al., 2007; Sharoni et al., 2017). To our knowledge, only two published foot care self-management studies included non-diabetic older adults (Omote et al., 2017; Waxman et al., 2003). The impact of a nurse-led, community-based foot care self-management intervention in older adults without diabetes has not been explored. Potential benefits of a nurse-led, community-based foot care self-management intervention include increased access to foot health assessment, improved foot health outcomes, enhanced health-related quality of life, and preserved independence and mobility.
Conceptual Model
The 2 Feet 4 Life foot care self-management intervention used Social Cognitive Theory to affect foot care behavior change. In addition to self-efficacy, the confidence an individual has that he or she can reach a goal, an individual also needs the knowledge, skills and motivation required to perform the behavior (Bandura, 1997). Additionally, observational learning and skills practice with appropriate feedback have been shown to increase self-efficacy (Bandura, 1997). Figure 1 portrays how Bandura’s four sources of self-efficacy were integrated into the 2 Feet 4 Life intervention. Specifically, personal mastery experiences occurred when foot care skills were practiced. Vicarious experience arose while watching others do their own foot care self-management. Verbal persuasion and motivational feedback from the principal investigator coached participants to engage in proper foot care self-management behaviors during intervention sessions. Participants experienced physiologic and emotional arousal as group practice decreased anxiety and sensations provided feedback. Collectively, the 2 Feet 4 Life intervention was designed to provide the practice and reinforcement needed to increase knowledge and skills that could improve foot care self-management behaviors.
Figure 1.
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Purpose
This study examined the feasibility (recruitment, retention, burden, fidelity, and acceptability) and preliminary efficacy of 2 Feet 4 Life, a foot care self-management intervention, on foot care knowledge, self-efficacy, behaviors, and foot pain in older adults without diabetes. Given that foot problem development was unlikely during the study timeframe, an additional exploratory purpose was to make a preliminary evaluation of the efficacy of 2 Feet 4 Life on foot health using the Revised-Foot Health Score (R-FHS; Baba et al., 2015, ).
Methods
Design, Setting and Sample
This pilot study used a two-group experimental design with repeated measures over a seven-month timeframe. The intervention, 2 Feet 4 Life, was the independent variable. Dependent variables included foot care knowledge, self-efficacy, behaviors, foot pain and foot health. This study was conducted in two suburban senior centers, over 20 miles apart, near a large Midwestern city. To prevent study contamination, one center’s participants received the 2 Feet 4 Life Intervention, while the other center’s participants served as the Control group. Recruitment, retention, burden, and fidelity data, as well as intervention acceptability data, were collected as indicators of study feasibility. Data were collected between September 2018 and April 2019.
Study participants were a nonprobability sample of senior center members. Inclusion criteria included age 65 or older, English-speaking, legally competent to provide informed consent, and willing to participate in the study. Potential participants were excluded based on the following criteria: currently seeing a healthcare provider for foot care, self-reported diabetes, non-traumatic amputation, legal blindness, demonstrated inability to reach their feet or see dots on their feet, Mental Status Screener Score ≤2, absent pedal pulses, ingrown toenail(s) or open foot ulcer(s). As current literature recommends group sizes of six to eight when teaching psychomotor skills (Snider et al., 2012) and pilot study sample sizes can be based on participant and budget availability (Leon et al., 2011), the desired sample size was 32 with the Intervention group (n=16) being divided into two class sections of eight participants each.
Intervention
The 2 Feet 4 Life foot care self-management intervention was modeled after the FOOTSTEP program (Waxman et al., 2003) and Diabetic Empowerment and Education Program (Castillo et al., 2010) and met diabetic foot care self-management guidelines (Haas et al., 2014). 2 Feet 4 Life consisted of four weekly group intervention sessions lasting 60 minutes each. Week specific activities are described below.
Week One
The first session began with introductions, including an icebreaker game where participants described their feet in a single word. To establish a baseline level of foot care self-management, the group reviewed their current foot care practices. A 20 minute session was provided about approporiate foot hygeine that included inspection, washing and drying techniques, and overview of trimming techniques. The final activity was a video demonstration and practice of foot exercises (e.g. pointing toes, flexing feet, rolling a tennis ball under feet, scrunching a towel with toes, picking up objects with toes). A foot care tip handout and a folder was provided to hold each week’s printed materials.
Week Two
The second session began with a review of week one’s content with time for questions. The qualities of appropriate shoes were presented, a handout for choosing appropriate shoes was provided, and the group discussed currently used footwear. Each participant traced their bare foot on a piece of paper and compared the tracing to their shoe to determine if their shoe size was too small. The remainder of the session was spent in interactive lecture, discussion, and lecture about common foot problems and strategies to find correct answers to questions about any future foot health concerns.
Week Three
Session three began with review of week two’s information with an opportunity for questions. Participants received a foot care kit (i.e. nippers, files, pumice stone, lotion); kit contents and their appropriate usage were reviewed. Participants watched videos detailing proper pumice stone usage and appropriate toenail trimming techniques. The principal investigator demonstrated proper toenail trimming and filing. Participants performed foot care activities while the principal investigator provided individualized coaching and feedback. Group members also provided peer support. Finally, the group watched a video demonstration of foot self-massage followed by an opportunity to practice the skill. The homework assignment was to identify one barrier to their foot care self-management and one strategy to improve their foot care self-management.
Week Four
The final session began with a review of week three’s content with an opportunity for questions. The group discussed their barriers to foot care self-management and strategies to overcome their barriers. A final review of appropriate foot care self-management techniques was provided. The group was asked if there were any topics group members wanted to discuss that had not been covered during the sessions.
Instruments and Measures
Demographic and relevant clinical history was collected via self-report at baseline. Body mass index was calculated from measured height and weight. Changes to medical history were not re-assessed at Times 2, 3, and 4.
Recruitment and retention data were collected using a research log. Intervention fidelity data were collected using an intervention manual, intervention checklist, and intervention session digital recordings. To collect data on intervention acceptability, participant burden, and obtain suggestions for intervention improvement, participants were given a brief, verbally administered post-intervention satisfaction survey (see Table 1). The nine-item survey included three open-ended intervention acceptability questions asking what was “most helpful”, “least helpful,” and what participants “would change” about the intervention; one closed-ended question asked if they would “recommend the 2 Feet 4 Life intervention” to others. The remaining five closed-ended questions related to participant burden.
Table 1.
Post-Intervention Satisfaction Survey Questions
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Patient-reported outcomes (i.e. foot care knowledge, foot care self-efficacy, foot care behaviors, foot pain) were evaluated using tools available in the extant literature. Foot care knowledge was measured using the Foot Self-care Knowledge Questionnaire (FSKQ; Fan et al., 2006, 2013). Foot care self-efficacy was assessed using the Foot Care Confidence Scale (FCCS; Sloan, 2002). Foot care behaviors were examined using the Nottingham Assessment of Functional Footcare (NAFF; Lincoln et al., 2007). Foot pain was measured using the Manchester Foot Pain and Disability Index (MDFPI; Garrow et al., 2000). The observer-reported outcome was foot health. Foot health was assessed using the Revised-Foot Health Score (R-FHS; Baba et al., 2015; ). To provide additional data regarding the reliability of the four patient-reported outcomes (FSKQ, FCCS, NAFF, MDFPI), Cronbach’s alpha was determined for each tool. Reliability, validity, and scoring for all tools are described in Table 2. Bolded Cronbach’s alpha values were determined from data in this study.
Table 2.
Outcome tools: Reliability, Validity and Scoring
| Tool | Items & Scoring | Validity & Reliability |
|---|---|---|
| Foot Self-Care Knowledge Questionnaire (FSKQ) |
|
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| Foot Care Confidence Scale (FCCS) |
|
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| Nottingham Assessment of Functional Footcare (NAFF) |
|
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| Manchester Foot Pain and Disability Index (MFPDI) |
|
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| Revised Foot Health Score (R-FHS) |
|
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Note. Bolded Cronbach’s alpha values were determined from data in this study
Procedures
Prior to the study’s initiation, approval was received from the Institutional Review Board of the University of Missouri – Columbia (IRB #2011705). In addition, a community service agreement was created between the university and the intervention senior center.
Informal group information sessions were held at each senior center to identify interested individuals. A separate, private screening was scheduled where informed consent was obtained, demographic, clinical and screening data were collected, and the patient-reported outcome tools and foot health assessment were completed. Participants received monetary compensation for their time after each visit up to a maximum of $100 for those attending all required study visits.
Intervention group participants completed the patient-reported outcome tools at four time points in the study: Time 1 (baseline), Time 2 (one month), Time 3 (four months) and Time 4 (seven months). The observer-reported outcome tool was completed at the same four time points. All measurement visits occurred in a private room at the senior centers. The post-intervention satisfaction survey was verbally administered one week after the last intervention session and digitally recorded to minimize investigator and participant burden.
The Control group received no intervention or attention. The Control group was randomized into two sub-groups of 8 participants: True control subgroup and Bias control subgroup. The True control sub-group completed the same patient-reported outcome tools and had their foot health assessed using the observer-reported outcome tool at the same four time points as the Intervention group. To help evaluate the potential for recall bias, the Bias control subgroup only completed the patient-reported outcome tools and had their foot health assessed at Time 1 (baseline) and Time 4 (7 months).
Data Analysis
Quantitative data were double entered into a password protected data base and checked for accuracy by comparing the two Excel files for differences prior to analysis. Data were checked for missing or extreme values. Statistical analysis on aggregate de-identified data was performed with the support of a statistician using the statistical package IBM SPSS (version 24). General descriptive statistics were used to summarize the demographic and clinical data by group. Continuous variables were reported as a mean±standard deviation and analyzed using an analysis of variance. Categorical variables were reported as percentages and analyzed by Chi-squared test or Fisher’s exact test. The normality of the outcome data was tested using skewness, kurtosis, Kolmogorov-Smirnov test for normality, Q-Q plots, and histograms. None of the outcome data were normally distributed (p<.001). Effect sizes were calculated using a two-way repeated measures ANOVA with two groups and four time points using an autocorrelation matrix with rho = 0.6.
Intervention sessions and participant responses to the post-intervention satisfaction survey questions were digitally recorded, transcribed verbatim by an outside, professional transcriptionist, and reviewed for accuracy. Intervention session transcripts were analyzed for fidelity by comparing the content covered in each session to the Intervention Checklist for each session. Additionally, intervention session transcripts were compared between the two intervention sections each week to assess for intervention delivery consistency between sections.
Transcripts from the post-intervention satisfaction survey were reviewed and coded according to open or closed-ended questions. Narrative responses to closed-ended satisfaction questions were analyzed with descriptive statistics and reported as percentages. Narrative responses to open ended satisfaction questions were categorized by topic and aligned to the study’s conceptual framework and reported as percentages. Categories were reviewed and verified by two PhD-prepared nurse scientists.
Results
General Characteristics of Study Participants
On average, the usual participant was a 73-year-old (range 65–88, sd 6.6) Caucasian (86%), married (59%), female (90%) with at least an associate’s degree (55%), and a household income of $25,000-$35,000 a year. The Intervention group included two Native American and one Asian American individuals; the True control group included one Hispanic/Latinx American individual. No Black/African American individuals participated. Typically, participants were overweight (BMI 27.3 kg/m2 [range 18.8–42.7, sd 5.5]) adults with a history of arthritis and hypertension. No participants currently smoked or used other tobacco products. Compared to both Control sub-groups, a greater proportion of participants in the Intervention group had hypertension (p=.046). Additionally, participants in the True control group were almost eight years younger than the Intervention group (p=.025). Otherwise, the clinical, demographic, and medical history data were not different between groups at baseline (Table 3).
Table 3.
Participant Clinical Data, Demographic Information, and Medical History by Group
| Intervention Group (n=15) No. (%) | True Control Group (n=7) No. (%) | Bias Control Group (n=7) No. (%) | P value | |
|---|---|---|---|---|
| Sexa | .191 | |||
| Female | 12 (80%) | 7 (100%) | 7 (100%) | |
| Raceb | .523 | |||
| American Indian | 2 (13%) | 0 (0%) | 0 (0%) | |
| White | 12 (80%) | 7 (100%) | 6 (86%) | |
| Asian | 1 (7%) | 0 (0%) | 1 (14%) | |
| Education levelb | .409 | |||
| High School/Some College | 8 (53%) | 3 (43%) | 2 (28%) | |
| Associate/Bachelor’s degree | 5 (33%) | 3 (43%) | 4 (57%) | |
| Master’s Degree | 2 (13%) | 1 (14%) | 0 (0%) | |
| Professional school degree | 0 (0%) | 0 (0%) | 1 (14%) | |
| Marital Statusb | .180 | |||
| Married | 8 (53%) | 5 (71%) | 4 (57%) | |
| Divorced | 2 (13%) | 2 (29%) | 0 (0%) | |
| Widowed | 5 (33%) | 0 (0%) | 3 (43%) | |
| Living Arrangementsb | .667 | |||
| Alone | 4 (27%) | 2 (29%) | 3 (43%) | |
| With Spouse/Family | 9 (60%) | 5 (70%) | 4 (57%) | |
| In Senior Housing | 2 (13%) | 0 (0%) | 0 (0%) | |
| Annual Incomeb | .278 | |||
| Less than $25,000 | 5 (34%) | 2 (28%) | 2 (28%) | |
| $25,000-$50,000 | 6 (40%) | 1(14%) | 0 (0%) | |
| More than $50,000 | 2 (13%) | 1 (14%) | 4 (57%) | |
| Prefer not to answer | 2 (13%) | 3 (43%) | 1 (14%) | |
| Medical Historyb | ||||
| Arthritis | 8 (53%) | 2 (29%) | 1 (14%) | .490 |
| Cardiac Disease | 3 (20%) | 0 (0%) | 1 (14%) | .424 |
| Former Smoker | 3 (20%) | 3 (43%) | 2 (29%) | .499 |
| Hypertension | 11 (66%) | 2 (29%) | 2 (29%) | .046* |
| Peripheral Artery Disease | 2 (13%) | 0 (0%) | 0 (0%) | .344 |
| Peripheral Neuropathy | 3 (20%) | 0 (0%) | 0 (0%) | .191 |
| Peripheral Venous Disease | 5 (33%) | 1 (14%) | 0 (0%) | .211 |
| Stroke | 0 (0%) | 0 (0%) | 0 (0%) |
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Note.
a =
Chi Square.
b=
Fisher’s Exact test.
*=
p<.05.
Feasibility
Recruitment, Retention, and Attrition
Initially, 69 older adults expressed interest in the study; of those, 47 (68.1%) individuals were contacted and screened. Of the 47 screened, 15 (31.9%) either did not meet eligibility requirements or declined to participate. A total of 32 individuals were consented: 16 from the senior center assigned to be the Intervention group, 16 from the senior center assigned to be the True control and Bias control sub-groups. The primary barrier to recruitment and retention was the busy schedules of the potential participants at the senior centers. Some older adults who did not participate could not find time within their personal schedules to meet for study sessions. Attrition rates were low: 9.4% (overall sample), 6.3% (Intervention group), 12.5% (True control sub-group), and 12.5% (Bias control sub-group). Attrition was due to personal/family concerns (n=2) and loss to follow up (n=1).
Burden
Investigator.
Enrollment and baseline data collection took approximately 45 minutes per participant; subsequent follow-up visits each lasted about 20 minutes. Each intervention session required an additional 20–30 minutes (above and beyond the 60-minute intervention) for set-up, checking the audio-visual equipment, gathering instructional materials, and clean up.
Participant.
All Intervention group participants (100%; 15/15) noted that making time for the weekly intervention sessions was not difficult because they could choose between two days/times to attend. Likewise, 100% (15/15) of Intervention group participants reported the number of intervention sessions was appropriate. With respect to intervention session length, 86.7% (13/15) found one-hour sessions acceptable. However, 13.3% (2/15) of participants indicated 30–45-minute sessions would be preferable. Regarding the patient-reported outcome tools, 100% (15/15) of the Intervention group participants found the tools to be quick and easy to complete, taking no more than 15 minutes to complete all four tools.
Intervention Fidelity
The principal investigator, a certified foot care nurse, designed the intervention and conducted all the intervention sessions. Analysis of the transcripts revealed the delivery of the intervention sessions was faithful to the intervention checklist and manual. Additionally, delivery of intervention sessions was consistent between the two intervention sections each week. Two participants missed a single intervention session (one missed session one; one session four), but both were rescheduled the following week for a make-up session with the principal investigator who ensured all intervention materials and content were covered. As the 2 Feet 4 Life intervention involved actual behavioral skills practice, the principal investigator visually verified that 100% of Intervention group participants safely implemented the appropriate behavioral foot care skills taught; thus, confirming intervention receipt.
Acceptability
Overall, 100% (15/15) of the Intervention group participants found the 2 Feet 4 Life intervention helpful and valuable and would recommend it to others. The most helpful aspect of the intervention (73%, 11/15) was the Knowledge gained about proper footcare. Regarding Behaviors, 20% (3/15) identified specific behaviors such as drying between toes and keeping foot care supplies conveniently located as most helpful. Pertaining to Skills, 13.3% (2/15) singled out practicing how to cut their toenails correctly as most helpful. About 6% (1/15) viewed gaining Confidence about performing their own foot care as most helpful. Twenty percent of participants (3/15) found ‘everything’ helpful. Of note, nearly 27% (4/15) described teaching strategies such as using visual aids, incorporating technology, and reinforcing learning by employing multiple modalities (e.g., lecture, demonstration, return demonstration) as particularly helpful.
In contrast, most Intervention group participants (60%; 9/15) were unable to identify any part of the intervention as “least helpful”. Twenty percent (3/15) pinpointed foot care content they did not like being instructed to avoid (e.g., putting lotion between toes [1/15], going barefoot [2/15]). Four participants (26.7%) suggested changes related to accessibility of teaching materials (font size, PowerPoint background color, availability of video links) and classroom management (closer seating). One participant (6%) wanted more foot care practice time. Additionally, one participant (6%) would have preferred to complete the satisfaction survey at the last intervention session. No participants expressed concerns about displaying their feet and/or practicing foot care in front of the group during the consent process, during the intervention sessions, or in the post-intervention survey.
Preliminary Efficacy
The detailed outcomes of the 2 Feet 4 Life intervention by group and over time are provided in Table 4 and summarized briefly below. Baseline foot care knowledge was similar and fairly high at Time 1 for all groups. The Intervention and True Control group’s foot care knowledge were equivalent at Time 3 and Time 4; however, the Bias control group’s knowledge did not change during the study. Self-efficacy scores were identical and very high for all groups at Time 1 with minimal changes over time. The Intervention group’s foot care behavior score was slightly higher than either of the Control groups at Time 1. The Intervention group’s foot care behaviors increased slightly at each time point and had the largest overall increase during the study. The Bias control group had the smallest increase in foot care behaviors. Overall, all groups had very little to no foot pain at Time 1 and with minimal changes throughout the study duration. Although slightly better for both Control sub-groups than the Intervention group, baseline foot health was fairly good for all groups. The Intervention group’s foot health slightly improved during the study while the two Control sub-groups’ foot health was fairly consistent with a very minimal change.
Table 4.
2 Feet 4 Life Outcome Results by Group and Time: Median, Mean, and Standard Deviation
| Time 1 | Time 2 | Time 3 | Time 4 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Median | Mean | SD | Median | Mean | SD | Median | Mean | SD | Median | Mean | SD | |
| R-FHS | ||||||||||||
| Intervention | 7.5 | 7.6 | 4.2 | 4 | 4.1 | 2.2 | 4 | 3.8 | 2.6 | 3 | 2.7 | 2.0 |
| True control | 5.5 | 5.8 | 1.8 | 4 | 4.8 | 2.9 | 4 | 4.1 | 1.7 | 6 | 5.8 | 3.5 |
| Bias control | 6.5 | 7.1 | 4.0 | 7 | 6.5 | 3.1 | ||||||
| MFPDI | ||||||||||||
| Intervention | 0.5 | 7.1 | 10.8 | 0.5 | 6 | 10.1 | 0 | 5.1 | 7.9 | 2 | 6.8 | 9.7 |
| True control | 0 | 2.1 | 4.1 | 0 | 2.2 | 3.8 | 1 | 3.4 | 7.7 | 2 | 2.4 | 3.5 |
| Bias control | 0 | 3.5 | 6.9 | 0 | 0.1 | 0.3 | ||||||
| FCCS | ||||||||||||
| Intervention | 59 | 54.9 | 6.4 | 58.5 | 56.8 | 4.3 | 58.5 | 56 | 4.8 | 58 | 56.9 | 3.4 |
| True control | 59 | 55.5 | 7.1 | 60 | 56.2 | 6 | 59 | 55.8 | 5.9 | 59 | 57 | 4.6 |
| Bias control | 59 | 55.6 | 6.6 | 60 | 56.5 | 5.8 | ||||||
| FSKQ | ||||||||||||
| Intervention | 8.5 | 7.1 | 3 | 10 | 9.6 | 1.1 | 10 | 9.5 | 1 | 10 | 9.7 | 1.0 |
| True control | 8 | 7.8 | 2.1 | 9 | 9.1 | 1.5 | 10 | 9.1 | 2.6 | 10 | 9.2 | 1.6 |
| Bias control | 8 | 7.8 | 2 | 8 | 8.2 | 1.8 | ||||||
| NAFF | ||||||||||||
| Intervention | 50.5 | 49.5 | 8.7 | 54 | 55.1 | 10.7 | 58.5 | 56.3 | 9.1 | 59 | 56.1 | 8.9 |
| True control | 47.5 | 48 | 6.8 | 50 | 49.7 | 6.2 | 53 | 52 | 5.3 | 53 | 51.4 | 7.3 |
| Bias control | 48 | 47.4 | 4.1 | 50 | 47.2 | 6.4 | ||||||
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Note. FCCS=Foot Care Confidence Score; FSKQ=Foot Self-care Knowledge Questionnaire; NAFF=Nottingham Assessment of Functional Footcare; MFPDI=Manchester Foot Pain and Disability Index; R-FHS=Revised Foot Health Score; SD= Standard deviation.
Estimates of Intervention Effect Size
Given these pilot data, effect sizes were calculated. Large effect sizes were observed between groups for knowledge (4.339), self-efficacy (3.652), and behaviors (3.403). In contrast, small to moderate effects were seen between groups in pain (0.375) and foot health (0.376). Effect sizes within groups and within their interaction had large observed effect sizes for knowledge (1.316), behaviors (8.430), pain (9.796), and foot health (3.778). A small within groups effect size was only observed for self-efficacy (0.18). Results of a power analysis with alpha = 0.05 and power = 0.8 indicate future studies should have a minimum of 58 participants, 29 in each intervention and control group. To account for 20% attrition, total participants at the beginning of the study should equal 70, with 35 participants in each group.
Discussion
This pilot study revealed several useful findings. First, recruiting older adults from senior centers for a community-based research study was a viable strategy and study procedures effectively retained 90.6% of participants in a study lasting 7 months. Second, intervention fidelity was maintained, and 2 Feet 4 Life was practicably and safely implemented in a senior center setting with satisfactory researcher and participant burden. Third, Intervention group participants found 2 Feet 4 Life acceptable, valuable, and would recommend it to others. Fourth, although the sample was fairly knowledgeable with good foot care behaviors and foot health at baseline, the Intervention group did display modest improvements in foot care knowledge, foot care behaviors and foot health. Finally, 2 Feet 4 Life appears to have a large between groups effect size on foot care knowledge, foot care self-efficacy, and foot care behaviors as well as large effect sizes within groups and within their interaction for foot care knowledge, foot care behaviors, foot pain, and foot health.
The findings from this pilot study suggest the 2 Feet 4 Life Intervention was able to modestly improve foot care knowledge, foot care behaviors, and foot health in community-dwelling older adults without diabetes in a community-based setting. Moreover, based on the power analysis, these data suggest the 2 Feet 4 Life intervention has a sufficiently large effect size to support pursuing future research with this intervention. Although minor revisions to the intervention are addressed below, the preliminary efficacy data are encouraging and provide evidence that conducting a future fully powered study is needed to determine the clinically or statistically significant effect of the intervention.
High baseline levels of foot care knowledge and self-efficacy were not anticipated. As the Intervention group was engaged in other healthy behaviors like exercise class and health promotion programs at the senior centers, they were likely already experienced, knowledgeable, and confident about maintaining their health. While the Intervention group saw modest improvements, high baseline knowledge, self-efficacy, behaviors in all three groups likely caused a ceiling effect. Similarly, very low pain and fairly good foot health at baseline likely caused a floor effect. While having relatively healthy participants was an impediment to evaluating the efficacy of the intervention on patient-reported and observer-reported outcomes, fairly healthy participants were needed to establish the safety of the 2 Feet 4 Life intervention. Increases in self-efficacy, knowledge, behaviors and foot health were consistent with other interventions in persons without diabetes and those with diabetes who were low risk for foot ulcers (Fan et al., 2013; Omote et al., 2017; Waxman et al., 2003).
Results from the post-intervention satisfaction survey not only demonstrate the acceptability of the intervention, but also provide evidence to support 2 feet 4 Life treatment fidelity and intervention efficacy. Specifically, participants comprehended and appreciated the foot care knowledge, confidence, and skills gained (i.e., receipt of treatment) as well as recognized the foot care behaviors achieved (i.e. enactment of treatment; Borrelli et al., 2005). The satisfaction data also suggest the major concepts underlying Social Cognitive Theory were effectively integrated into the intervention. For example, in response to the intervention, participants reported a change of mindset to make proper foot care a priority. As proposed in the study conceptual framework (Figure 1), these findings suggest their new and reinforced foot care knowledge, skills, and confidence may be associated with the patient-reported trends in improved foot care behaviors and observer-reported trends in improved foot health.
Although safe, acceptable, and complete, intervention modifications may be needed to increase accessibility and acceptability, minimize participant burden, and increase efficacy. Modifications to increase teaching materials accessibility include choosing a lighter color and larger font for PowerPoint slides and providing handouts with links to video used during the sessions. New approaches are needed to increase the acceptability of behaviors that participants resisted changing (e.g., going barefoot, applying lotion between toes). To allow more time for practice and reinforcement, foot care skills practice could be started during intervention Week 2 rather than intervention Week 3. To decrease participant burden, future intervention sessions may need to be decreased to 45 minutes. Additionally, while the environmental component of Social Cognitive Theory is addressed late in the intervention, additional emphasis of this content may be needed to reinforce adherence to foot care self-management behaviors.
As foot care knowledge scores increased in both Intervention and True control groups over time, familiarity with the Foot Self-care Knowledge Questionnaire (FSKQ) tool may have impacted the results. Specifically, the act of completing the FSKQ tool four times may have essentially “taught” the True control sub-group the correct answers. Since the Bias control sub-group only completed FSKQ (and other patient reported outcome tools) twice, seven months apart, the potential for recall bias was less. While the small sample size of this pilot prevents the use of inferential statistics to assess for recall bias, scores in the True control sub-group tended to increase over time and frequency of testing, whereas the Bias control sub-group’s scores on the FSKQ remained fairly stable. This trend suggests that recall bias may exist for the FSKQ. Furthermore, the FSKQ consists of 11 simple, true-false style questions of which the correct answer is “yes” for 10 of the 11 questions. Given that prior research suggests true-false questions are susceptible to “acquiescence” bias—meaning participants are more likely to select “true” responses () —the FSKQ item construction may be problematic. Collectively, these data suggest that the FSKQ tool may need revision.
During the administration of the patient-reported outcome tools at Times 1, 2, 3, & 4, many participants anecdotally reported struggling with item wording, particularly on the Nottingham Assessment of Functional Footcare (NAFF; Lincoln et al., 2007). As the survey was developed in the U.K., the vocabulary and context of foot care is different than in the United States (U.S.). For example, ‘corn plasters’, ‘trainers’, and ‘mules’ included in the NAFF had to be clarified as ‘corn pads’, ‘tennis shoes’, and ‘slip on shoes’, respectively. Also, use of hot water bottles and radiators were questioned. While 2 Feet 4 Life was developed using diabetic foot self-management guidelines, foot care self-management behaviors are not identical for adults with and without diabetes. For example, older adults without diabetes may not need to contact their physician immediately at the first sign of a blister on their foot, unless they have “at risk” feet due to other chronic diseases (e.g. peripheral artery disease, venous insufficiency). Likewise, it may not be necessary for someone without diabetes to change their socks multiple times a day. Additionally, the reported internal consistency for the NAFF has ranged from poor to acceptable. Collectively, these data suggest that the NAFF tool requires revision to measure foot self-management behaviors more accurately in U.S. adults.
Our retention rate was higher (90.6% vs 78%) than the study conducted by Omote and colleagues (2017), where the intervention was offered in a community comprehensive care center. Several factors may have contributed to our high retention rate. First, participants were fairly healthy older adults who were already motivated to learn about self-management. While time spent at the senior center was focused on social activities, the center also was known for its health promotion programs and visits from student nurses. Older adults who are routinely engaged in community-based activities may be less likely to drop out of a study. Second, retention was made a high priority; participants received monthly, handwritten thank you/reminder cards plus obtained financial compensation that incrementally increased throughout the study. Third, Intervention group participants were allowed to choose which intervention session time they attended, either Wednesday afternoon or Friday morning. Giving participants the freedom to choose the intervention session that best fit their schedule may have contributed to our high retention rates. The low rate of attrition also may be attributable to the acceptability of the intervention: participants made the time and effort to attend the intervention sessions and follow up data collection times.
Limitations of this pilot study need to be acknowledged. Since the principal investigator had pre-existing relationships at both senior centers, recruitment and retention rates may have been impacted. However, participants had not previously received foot care from the principal investigator. Participants were predominantly low income, white, female adults which is consistent with the population at senior centers in the U. S. (National Council on Aging, 2015). Additionally, participants had fairly good baseline foot health as well as overall health. Using a homogenous sample for the pilot study minimized variability and assisted in the determination of effect size for variables of interest. That said, the sample did not accurately represent the socioeconomic and racial/ethnic diversity of the surrounding Midwestern community. Thus, future studies will need to recruit a more diverse sample of older adults with greater variability in foot health as well as overall health. The principal investigator was not blinded to group assignment and served as both interventionist and evaluated the observer-reported outcome of foot health (R-FHS). The Revised-Foot Health Score (R-FHS; Baba et al., 2015, ) has limited psychometric information and additional research is needed to validate the tool. The acceptability of the 2 Feet 4 Life intervention to nurses was beyond the scope of this pilot study and remains unknown. Future research is needed to examine this topic.
In conclusion, while foot problems are frequently overlooked by patients and the medical community, the outcomes of poor foot health can lead to impaired mobility which then can lead to falls, injuries, hospitalizations, and an inability to live independently. This was the first U.S. study to evaluate a nurse-run, community-based, foot care self-management intervention for older adults without diabetes. Findings demonstrated the feasibility, in terms of recruitment, retention, burden, fidelity, and acceptability, and preliminary efficacy of the 2 Feet 4 Life foot care self-management intervention in community-dwelling older adults without diabetes. Based on these positive preliminary data and the large estimates of intervention effect size, future fully powered research studies with adults with more complex and severe foot problems are warranted.
Acknowledgements
The authors would like to acknowledge Dr. Teresa Kelechi, project consultant, and dissertation committee members Drs. Vicki Conn, Lori Popejoy, and David Mehr of the University of Missouri-Columbia for their guidance regarding this project.
Funding
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by a Sigma Theta Tau International Doris Bloch Research Award; the University of Missouri Sinclair School of Nursing Toni and Jim Sullivan Endowed Research Fund for PhD Students; and Sigma Theta Tau International Zeta Delta Chapter-at-Large Research Grant. Stipend support for Jennifer O’Connor was provided by the National Institutes of Health/National Institute of Nursing Research T32 grant NR015426.
Footnotes
Clinical trial registry name: Foot Self-care in Older Adults
Registration number: NCT03656341
URL: https://clinicaltrials.gov/ct2/show/NCT03656341?term=NCT03656341&draw=2&rank=1
Declaration of Conflicting Interests
The Authors declare that there is no conflict of interest.
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