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Completed

NCT Number: NCT04395521

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

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, Queens University

Kingston, Ontario, K7L 3N6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diabetic foot self-management support

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

Sponsors and collaborators

Lead sponsor

Helen Obilor

Other

Collaborators

  • Wounds Canada

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 20, 2020
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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