Clinical trial NCT04395521: The Feasibility of a Facebook Group-based Program for Foot Self-management Support of Adults With Diabetes in Canada
Official title: A Facebook Group-based Program for Foot Self-management Support of Adults With Diabetes Mellitus: A Feasibility Study in Canada
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Patient education
Foot self-care
Foot self-care adherence
Social media
Self-management support
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Wounds Canada
First posted: 2020-05-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Access to a diabetic foot self-management support program via a Facebook group platform for 3 months.
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The number of participants that accepted the intervention.
timeFrame: Four weeks after the commencement of intervention.
measure: The level of participants' engagement in the Facebook group.
timeFrame: Throughout the intervention period (3 months).
measure: The efficacy of the study intervention on participants' foot self-care adherence.
timeFrame: Two time points > Baseline and at the end of the intervention period (3 months).
Secondary outcomes:
measure: The efficacy of the study intervention on participants' foot self-care confidence.
timeFrame: Two time points > Baseline and at the end of the intervention period (3 months).
measure: The efficacy of the study intervention on participants' perceived foot health status.
timeFrame: Two time points > Baseline and at the end of the intervention period (3 months).
measure: The efficacy of the study intervention on participants' awareness of community resources.
timeFrame: Two time points > Baseline and at the end of the intervention period (3 months).
measure: The efficacy of the study intervention on participants' communication with health care professionals.
timeFrame: Two time points > Baseline and at the end of the intervention period (3 months).
measure: The efficacy of the study intervention on participants' quality of life.
timeFrame: Two time points > Baseline and at the end of the intervention period (3 months).
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: School of Nursing, Queens University
state: Ontario
Study officials:
affiliation: Faculty of Health Sciences\School of Nursing, Queen's University
name: Helen N Obilor, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Health Sciences\School of Nursing, Queen's University
name: Kevin Woo, Ph.D.
role: STUDY_DIRECTOR
affiliation: Faculty of Health Sciences\School of Nursing, Queen's University
name: Rosemary Wilson, Ph.D.
role: STUDY_DIRECTOR
affiliation: Faculty of Health Sciences\School of Nursing, Queen's University
name: Joan E Tranmer, Ph.D
role: STUDY_DIRECTOR
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