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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04395521
• Other study ID #: 6029718
• Status: Completed
• Phase: N/A
• Start date: February 16, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: March 2023
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Intervention

Behavioral:
• Diabetic foot self-management support
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.

Locations

Country	Name	City	State
Canada	School of Nursing, Queens University	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Helen Obilor	Wounds Canada

Country where clinical trial is conducted

Canada, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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).
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).

External Links

•   Clinical best practice guidelines: Assessment and management of foot ulcers for people with diabetes.
•   Diabetes-prevalence and care practices: Findings.
•   Foundations of best practice for skin and wound management: Best practice recommendations for the prevention and management of diabetic foot ulcers
•   IDF diabetes atlas
•   IWGDF Practical Guidelines on the Prevention and Management of Diabetic Foot Disease.
•   Most popular social networks worldwide as of October 2019, ranked by number of active users.
•   Share of U.S. adults using social media, including Facebook, is mostly unchanged since 2018
•   Social Networking in Canada.
•   The economic impact of offloading devices for the prevention of amputations in Ontario.