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

March 20, 2023 updated by: Helen Obilor

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 3N6
        • School of Nursing, Queens University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Facebook group arm
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
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.
No Intervention: Standard care arm
Carry on with the routine diabetes care offered to the participants in their health facilities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of participants that accepted the intervention.
Time Frame: Four weeks after the commencement of 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.
Time Frame: Throughout the intervention period (3 months).
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.
Time Frame: Two time points > Baseline and at the end of the intervention period (3 months).
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.
Time Frame: Two time points > Baseline and at the end of the intervention period (3 months).
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.
Time Frame: Two time points > Baseline and at the end of the intervention period (3 months).
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.
Time Frame: Two time points > Baseline and at the end of the intervention period (3 months).
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.
Time Frame: Two time points > Baseline and at the end of the intervention period (3 months).
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.
Time Frame: Two time points > Baseline and at the end of the intervention period (3 months).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helen Obilor

Collaborators

Wounds Canada

Investigators

  • Principal Investigator: Helen N Obilor, MSc., Faculty of Health Sciences\School of Nursing, Queen's University
  • Study Director: Kevin Woo, Ph.D., Faculty of Health Sciences\School of Nursing, Queen's University
  • Study Director: Rosemary Wilson, Ph.D., Faculty of Health Sciences\School of Nursing, Queen's University
  • Study Director: Joan E Tranmer, Ph.D, Faculty of Health Sciences\School of Nursing, Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2021

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6029718

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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