The Feasibility of a Facebook Group-based Program for Foot Self-management Support of Adults With Diabetes in Canada

Study Overview
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Brief Summary
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The primary objective of this study is to examine the feasibility of a Facebook group-based program to support adults with diabetes in their foot self-care and prevention of foot ulcers. The sub-objectives are: 1. To determine the recruitment and retention rate of participants in the study. 2. To assess the acceptability of the Facebook group program among participants. 3. To determine the level and pattern of engagement by the participants within the Facebook group platform. 4. To determine the efficacy of the Facebook group program and how it works to improve diabetic foot care-related outcomes.

Official Title
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A Facebook Group-based Program for Foot Self-management Support of Adults With Diabetes Mellitus: A Feasibility Study in Canada

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Behavioral: Diabetic foot self-management support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of type I or II diabetes; 18 years of age or older reside in Canada Proficiency in the English language - understanding, speaking, reading, and writing. Have an active Facebook account or willing to create one Have access to the internet and computer or smartphone Exclusion Criteria: Declined consent Did not provide follow-up contact information Completed less than 60% of the baseline survey

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Access to a diabetic foot self-management support program via a Facebook group platform for 3 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Facebook group arm<br>Access to a diabetic foot self-management support program via a Facebook group platform for three months plus the standard care. | Behavioral: Diabetic foot self-management support<br>* Daily educational organic or inorganic posts (2 to 5) released in a timed sequence through a Hootsuite application plus peer interactions/support for three months.<br>|
| No Intervention: Standard care arm<br>Carry on with the routine diabetes care offered to the participants in their health facilities. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants that accepted the intervention. | Number of participants who scored above 70 in the questionnaire on acceptance and satisfaction with the Facebook group-based program. | Four weeks after the commencement of intervention. | 
| The level of participants' engagement in the Facebook group. | The number of participants who viewed and reacted (comments and likes) to educational posts. | Throughout the intervention period (3 months). | 
| The efficacy of the study intervention on participants' foot self-care adherence. | Mean difference in participants' baseline and three-month post-intervention foot self-care adherence. Foot self-care adherence will be assessed using an adapted Foot Self-Care Behavior Tool, which consists of 17 items on preventive and potentially destructive foot self-care practices with a score range of 0 - 87. | Two time points > Baseline and at the end of the intervention period (3 months). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of the study intervention on participants' foot self-care confidence. | Mean difference in participants' baseline and three-month post-intervention foot self-care confidence. Foot self-care confidence will be measured using the Foot Care Confidence Scale (FCCS), which consists of 12 items on a five-point Likert scale with a score range of 12 - 60. | Two time points > Baseline and at the end of the intervention period (3 months). | 
| The efficacy of the study intervention on participants' perceived foot health status. | Mean difference in participants' baseline and three-month post-intervention perceived foot health status. Perceived foot health status will be assessed using the general foot health questions 9 and 12 of the Foot Health Status Questionnaire with a score range of 2 - 10. | Two time points > Baseline and at the end of the intervention period (3 months). | 
| The efficacy of the study intervention on participants' awareness of community resources. | Mean difference in participants' baseline and three-month post-intervention awareness of community resources. Participants' awareness of community resources will be assessed by asking them to rate the extent to which they can successfully locate available resources in their community for preventing DFU on a scale of 0 - 10. | Two time points > Baseline and at the end of the intervention period (3 months). | 
| The efficacy of the study intervention on participants' communication with health care professionals. | Mean difference in participants' baseline and three-month post-intervention communication with health care professionals. Participants' level of communication with health care professionals about their foot health will be assessed using an adapted Stanford University Chronic Disease Self-Management Program Communication with Physicians' Tool with a score range of 0 - 15. | Two time points > Baseline and at the end of the intervention period (3 months). | 
| The efficacy of the study intervention on participants' quality of life. | Mean difference in participants' baseline and three-month post-intervention quality of life score. The participants' quality of life will be assessed using the Medical Outcome Study Short Form questionnaire (SF-12). | Two time points > Baseline and at the end of the intervention period (3 months). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient education, Foot self-care, Foot self-care adherence, Social media, Self-management support