Back to resultsThe Feasibility of a Facebook Group-based Program for Foot Self-management Support of Adults With Diabetes in Canada
Primary Purpose
Diabetic Foot Ulcer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Diabetic foot self-management support
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetic Foot Ulcer focused on measuring Patient education, Foot self-care, Foot self-care adherence, Social media, Self-management support
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
Sites / Locations
- School of Nursing, Queens University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Facebook group arm
Standard care arm
Arm Description
Access to a diabetic foot self-management support program via a Facebook group platform for three months plus the standard care.
Carry on with the routine diabetes care offered to the participants in their health facilities.
Outcomes
Primary Outcome Measures
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.
The level of participants' engagement in the Facebook group.
The number of participants who viewed and reacted (comments and likes) to educational posts.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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).
Full Information
NCT ID
NCT04395521
First Posted
May 14, 2020
Last Updated
March 20, 2023
Sponsor
Helen Obilor
Collaborators
Wounds Canada
1. Study Identification
Unique Protocol Identification Number
NCT04395521
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Helen Obilor
Collaborators
Wounds Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Patient education, Foot self-care, Foot self-care adherence, Social media, Self-management support
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Access to a diabetic foot self-management support program via a Facebook group platform for 3 months.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Facebook group arm
Arm Type
Experimental
Arm Description
Access to a diabetic foot self-management support program via a Facebook group platform for three months plus the standard care.
Arm Title
Standard care arm
Arm Type
No Intervention
Arm Description
Carry on with the routine diabetes care offered to the participants in their health facilities.
Intervention Type
Behavioral
Intervention Name(s)
Diabetic foot self-management support
Intervention Description
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 Outcome Measure Information:
Title
The number of participants that accepted the intervention.
Description
Number of participants who scored above 70 in the questionnaire on acceptance and satisfaction with the Facebook group-based program.
Time Frame
Four weeks after the commencement of intervention.
Title
The level of participants' engagement in the Facebook group.
Description
The number of participants who viewed and reacted (comments and likes) to educational posts.
Time Frame
Throughout the intervention period (3 months).
Title
The efficacy of the study intervention on participants' foot self-care adherence.
Description
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.
Time Frame
Two time points > Baseline and at the end of the intervention period (3 months).
Secondary Outcome Measure Information:
Title
The efficacy of the study intervention on participants' foot self-care confidence.
Description
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.
Time Frame
Two time points > Baseline and at the end of the intervention period (3 months).
Title
The efficacy of the study intervention on participants' perceived foot health status.
Description
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.
Time Frame
Two time points > Baseline and at the end of the intervention period (3 months).
Title
The efficacy of the study intervention on participants' awareness of community resources.
Description
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.
Time Frame
Two time points > Baseline and at the end of the intervention period (3 months).
Title
The efficacy of the study intervention on participants' communication with health care professionals.
Description
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.
Time Frame
Two time points > Baseline and at the end of the intervention period (3 months).
Title
The efficacy of the study intervention on participants' quality of life.
Description
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).
Time Frame
Two time points > Baseline and at the end of the intervention period (3 months).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen N Obilor, MSc.
Organizational Affiliation
Faculty of Health Sciences\School of Nursing, Queen's University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Woo, Ph.D.
Organizational Affiliation
Faculty of Health Sciences\School of Nursing, Queen's University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rosemary Wilson, Ph.D.
Organizational Affiliation
Faculty of Health Sciences\School of Nursing, Queen's University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joan E Tranmer, Ph.D
Organizational Affiliation
Faculty of Health Sciences\School of Nursing, Queen's University
Official's Role
Study Director
Facility Information:
Facility Name
School of Nursing, Queens University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26303266
Citation
Abedin T, Ahmed S, Al Mamun M, Ahmed SW, Newaz S, Rumana N, Turin TC. YouTube as a source of useful information on diabetes foot care. Diabetes Res Clin Pract. 2015 Oct;110(1):e1-e4. doi: 10.1016/j.diabres.2015.08.003. Epub 2015 Aug 13.
Results Reference
background
PubMed Identifier
28126155
Citation
Abedin T, Al Mamun M, Lasker MAA, Ahmed SW, Shommu N, Rumana N, Turin TC. Social Media as a Platform for Information About Diabetes Foot Care: A Study of Facebook Groups. Can J Diabetes. 2017 Feb;41(1):97-101. doi: 10.1016/j.jcjd.2016.08.217.
Results Reference
background
PubMed Identifier
29067251
Citation
Adarmouch L, Elyacoubi A, Dahmash L, El Ansari N, Sebbani M, Amine M. Short-term effectiveness of a culturally tailored educational intervention on foot self-care among type 2 diabetes patients in Morocco. J Clin Transl Endocrinol. 2017 Feb 9;7:54-59. doi: 10.1016/j.jcte.2017.01.002. eCollection 2017 Mar.
Results Reference
background
PubMed Identifier
28614678
Citation
Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.
Results Reference
background
PubMed Identifier
28273040
Citation
Bilandzic A, Rosella L. The cost of diabetes in Canada over 10 years: applying attributable health care costs to a diabetes incidence prediction model. Health Promot Chronic Dis Prev Can. 2017 Feb;37(2):49-53. doi: 10.24095/hpcdp.37.2.03.
Results Reference
background
PubMed Identifier
19362699
Citation
Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.
Results Reference
background
PubMed Identifier
26452160
Citation
Bus SA, van Netten JJ. A shift in priority in diabetic foot care and research: 75% of foot ulcers are preventable. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:195-200. doi: 10.1002/dmrr.2738.
Results Reference
background
PubMed Identifier
25514250
Citation
Dorresteijn JA, Kriegsman DM, Assendelft WJ, Valk GD. Patient education for preventing diabetic foot ulceration. Cochrane Database Syst Rev. 2014 Dec 16;2014(12):CD001488. doi: 10.1002/14651858.CD001488.pub5.
Results Reference
background
PubMed Identifier
23823459
Citation
Fan L, Sidani S, Cooper-Brathwaite A, Metcalfe K. Improving foot self-care knowledge, self-efficacy, and behaviors in patients with type 2 diabetes at low risk for foot ulceration: a pilot study. Clin Nurs Res. 2014 Dec;23(6):627-43. doi: 10.1177/1054773813491282. Epub 2013 Jul 3.
Results Reference
background
PubMed Identifier
17280936
Citation
Frykberg RG, Zgonis T, Armstrong DG, Driver VR, Giurini JM, Kravitz SR, Landsman AS, Lavery LA, Moore JC, Schuberth JM, Wukich DK, Andersen C, Vanore JV; American College of Foot and Ankle Surgeons. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. 2006 Sep-Oct;45(5 Suppl):S1-66. doi: 10.1016/S1067-2516(07)60001-5.
Results Reference
background
Citation
Gershater MA, Pilhammar E, Apelqvist J, Alm-Roijer C. Patient education for the prevention of diabetic foot ulcers. European Diabetes Nursing. 2011: 8: 102-107b.
Results Reference
background
PubMed Identifier
24922170
Citation
Grady PA, Gough LL. Self-management: a comprehensive approach to management of chronic conditions. Am J Public Health. 2014 Aug;104(8):e25-31. doi: 10.2105/AJPH.2014.302041. Epub 2014 Jun 12.
Results Reference
background
PubMed Identifier
28911921
Citation
Jeffcoate W, Barron E, Lomas J, Valabhji J, Young B. Using data to tackle the burden of amputation in diabetes. Lancet. 2017 Oct 21;390(10105):e29-e30. doi: 10.1016/S0140-6736(17)32401-7. Epub 2017 Sep 11. No abstract available.
Results Reference
background
PubMed Identifier
29559450
Citation
Jeffcoate WJ, Vileikyte L, Boyko EJ, Armstrong DG, Boulton AJM. Current Challenges and Opportunities in the Prevention and Management of Diabetic Foot Ulcers. Diabetes Care. 2018 Apr;41(4):645-652. doi: 10.2337/dc17-1836.
Results Reference
background
PubMed Identifier
18758747
Citation
Lincoln NB, Radford KA, Game FL, Jeffcoate WJ. Education for secondary prevention of foot ulcers in people with diabetes: a randomised controlled trial. Diabetologia. 2008 Nov;51(11):1954-61. doi: 10.1007/s00125-008-1110-0. Epub 2008 Aug 30.
Results Reference
background
PubMed Identifier
26835804
Citation
Maydick DR, Acee AM. Comorbid Depression and Diabetic Foot Ulcers. Home Healthc Now. 2016 Feb;34(2):62-7. doi: 10.1097/NHH.0000000000000340.
Results Reference
background
PubMed Identifier
22608868
Citation
McGowan PT. Self-management education and support in chronic disease management. Prim Care. 2012 Jun;39(2):307-25. doi: 10.1016/j.pop.2012.03.005. Epub 2012 Apr 24.
Results Reference
background
PubMed Identifier
18347122
Citation
Monami M, Longo R, Desideri CM, Masotti G, Marchionni N, Mannucci E. The diabetic person beyond a foot ulcer: healing, recurrence, and depressive symptoms. J Am Podiatr Med Assoc. 2008 Mar-Apr;98(2):130-6. doi: 10.7547/0980130.
Results Reference
background
PubMed Identifier
26448748
Citation
Monami M, Zannoni S, Gaias M, Nreu B, Marchionni N, Mannucci E. Effects of a Short Educational Program for the Prevention of Foot Ulcers in High-Risk Patients: A Randomized Controlled Trial. Int J Endocrinol. 2015;2015:615680. doi: 10.1155/2015/615680. Epub 2015 Sep 10.
Results Reference
background
PubMed Identifier
23615206
Citation
Moorhead SA, Hazlett DE, Harrison L, Carroll JK, Irwin A, Hoving C. A new dimension of health care: systematic review of the uses, benefits, and limitations of social media for health communication. J Med Internet Res. 2013 Apr 23;15(4):e85. doi: 10.2196/jmir.1933.
Results Reference
background
Citation
Obilor HN, Adejumo PO. Assessment of diabetic foot ulcer-related pain and its relationship to quality of life. Wound Practice and Research. 2015; 23 (3): 124-131.
Results Reference
background
Citation
Ogrin R, Viswanathan R, Aylen T, Wallace F, Scott J, Kumar D. Co-design of an evidence-based health education diabetes foot app to prevent serious foot complications: a feasibility study. Practical Diabetes. 2018; 35: 203-209d.
Results Reference
background
PubMed Identifier
29343460
Citation
Partridge SR, Gallagher P, Freeman B, Gallagher R. Facebook Groups for the Management of Chronic Diseases. J Med Internet Res. 2018 Jan 17;20(1):e21. doi: 10.2196/jmir.7558.
Results Reference
background
PubMed Identifier
26159633
Citation
Patel R, Chang T, Greysen SR, Chopra V. Social Media Use in Chronic Disease: A Systematic Review and Novel Taxonomy. Am J Med. 2015 Dec;128(12):1335-50. doi: 10.1016/j.amjmed.2015.06.015. Epub 2015 Jul 6.
Results Reference
background
PubMed Identifier
30291064
Citation
Petrovski G, Zivkovic M. Impact of Facebook on Glucose Control in Type 1 Diabetes: A Three-Year Cohort Study. JMIR Diabetes. 2017 Jun 7;2(1):e9. doi: 10.2196/diabetes.7693.
Results Reference
background
PubMed Identifier
26335366
Citation
Schaper NC, Van Netten JJ, Apelqvist J, Lipsky BA, Bakker K; International Working Group on the Diabetic Foot. Prevention and management of foot problems in diabetes: a Summary Guidance for Daily Practice 2015, based on the IWGDF Guidance Documents. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:7-15. doi: 10.1002/dmrr.2695.
Results Reference
background
PubMed Identifier
29534070
Citation
Ahmad Sharoni SK, Abdul Rahman H, Minhat HS, Shariff-Ghazali S, Azman Ong MH. The effects of self-efficacy enhancing program on foot self-care behaviour of older adults with diabetes: A randomised controlled trial in elderly care facility, Peninsular Malaysia. PLoS One. 2018 Mar 13;13(3):e0192417. doi: 10.1371/journal.pone.0192417. eCollection 2018.
Results Reference
background
PubMed Identifier
26916809
Citation
Ahmad Sharoni SK, Minhat HS, Mohd Zulkefli NA, Baharom A. Health education programmes to improve foot self-care practices and foot problems among older people with diabetes: a systematic review. Int J Older People Nurs. 2016 Sep;11(3):214-39. doi: 10.1111/opn.12112. Epub 2016 Feb 25.
Results Reference
background
PubMed Identifier
31135201
Citation
Smith PE, McGuire J, Falci M, Poudel DR, Kaufman R, Patterson MA, Pelleschi B, Shin E. Analysis of YouTube as a Source of Information for Diabetic Foot Care. J Am Podiatr Med Assoc. 2019 Mar;109(2):122-126. doi: 10.7547/16-149.
Results Reference
background
PubMed Identifier
23433271
Citation
Tickle-Degnen L. Nuts and bolts of conducting feasibility studies. Am J Occup Ther. 2013 Mar-Apr;67(2):171-6. doi: 10.5014/ajot.2013.006270.
Results Reference
background
PubMed Identifier
9487173
Citation
Torgerson DJ, Sibbald B. Understanding controlled trials. What is a patient preference trial? BMJ. 1998 Jan 31;316(7128):360. doi: 10.1136/bmj.316.7128.360. No abstract available.
Results Reference
background
PubMed Identifier
25083128
Citation
Ventola CL. Social media and health care professionals: benefits, risks, and best practices. P T. 2014 Jul;39(7):491-520.
Results Reference
background
Citation
Woo K. New initiative: Online social support program for people with diabetes and foot ulcers. Diabetic Foot Canada. 2014; 2(3): 11-12.
Results Reference
background
PubMed Identifier
26074389
Citation
Woodbury MG, Botros M, Kuhnke JL, Greene J. Evaluation of a peer-led self-management education programme PEP Talk: Diabetes, Healthy Feet and You. Int Wound J. 2013 Dec;10(6):703-11. doi: 10.1111/iwj.12188.
Results Reference
background
Links:
URL
http://www.woundscanada.ca/docman/public/health-care-professional/bpr-workshop/895-wc-bpr-prevention-and-management-of-diabetic-foot-ulcers-1573r1e-final/file
Description
Foundations of best practice for skin and wound management: Best practice recommendations for the prevention and management of diabetic foot ulcers
URL
http://www.diabetes.ca/advocacy---policies/advocacy-reports/amputation-prevention-reports
Description
The economic impact of offloading devices for the prevention of amputations in Ontario.
URL
http://www.idf.org/e-library/epidemiology-research/diabetes-atlas.html
Description
IDF diabetes atlas
URL
http://www.pewresearch.org/fact-tank/2019/04/10/share-of-u-s-adults-using-social-media-including-facebook-is-mostly-unchanged-since-2018/
Description
Share of U.S. adults using social media, including Facebook, is mostly unchanged since 2018
URL
http://rnao.ca/sites/rnao-ca/files/Assessment_and_Management_of_Foot_Ulcers_for_People_with_Diabetes_Second_Edition1.pdf
Description
Clinical best practice guidelines: Assessment and management of foot ulcers for people with diabetes.
URL
http://iwgdfguidelines.org/wp-content/uploads/2019/05/01-IWGDF-practical-guidelines-2019.pdf
Description
IWGDF Practical Guidelines on the Prevention and Management of Diabetic Foot Disease.
URL
http://www.statista.com/statistics/272014/global-social-networks-ranked-by-number-of-users/
Description
Most popular social networks worldwide as of October 2019, ranked by number of active users.
URL
http://www.statista.com/study/32357/social-networking-in-canada-statista-dossier/
Description
Social Networking in Canada.
URL
https://www150.statcan.gc.ca/n1/pub/82-003-x/2008003/article/10663/5202464-eng.htm
Description
Diabetes-prevalence and care practices: Findings.
Learn more about this trial
The Feasibility of a Facebook Group-based Program for Foot Self-management Support of Adults With Diabetes in Canada
We'll reach out to this number within 24 hrs