Diabetic Foot UlcerNCT04395521
The Feasibility of a Facebook Group-based Program for Foot Self-management Support of Adults With Diabetes in Canada
A study testing Diabetic foot self-management support in people with Diabetic Foot Ulcer, run by Helen Obilor at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Diabetic foot self-management support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 16 Feb 2021to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Declined consent
- Did not provide follow-up contact information
- Completed less than 60% of the baseline survey
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Diabetic foot self-management support
- Keywords
- Patient education, Foot self-care, Foot self-care adherence, Social media, Self-management support
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetic foot self-management supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Facebook group arm | Experimental | Access to a diabetic foot self-management support program via a Facebook group platform for three months plus the standard care. Receives: Behavioral: Diabetic foot self-management support |
| Standard care arm | No intervention | Carry on with the routine diabetes care offered to the participants in their health facilities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks after the commencement of intervention.
The level of participants' engagement in the Facebook group.
The number of participants who viewed and reacted (comments and likes) to educational posts.
Measured: Throughout the intervention period (3 months).
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.
Measured: Two time points > Baseline and at the end of the intervention period (3 months).
Secondary outcomes (5)
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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).
Measured: Two time points > Baseline and at the end of the intervention period (3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start16 Feb 2021
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Access to a diabetic foot self-management support program via a Facebook group platform for 3 months.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helen Obilor
- Sponsor type
- University, hospital or other
- Collaborators
- Wounds Canada
- Responsible party
- Sponsor-investigator, Helen Obilor, Queen's University
- Investigators
- Helen N Obilor, MSc., Principal investigator, Faculty of Health Sciences\School of Nursing, Queen's UniversityKevin Woo, Ph.D., Study director, Faculty of Health Sciences\School of Nursing, Queen's UniversityRosemary Wilson, Ph.D., Study director, Faculty of Health Sciences\School of Nursing, Queen's UniversityJoan E Tranmer, Ph.D, Study director, Faculty of Health Sciences\School of Nursing, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395521
- Sponsor's protocol ID
- 6029718
- Status last verified
- Mar 2023
- First submitted
- 14 May 2020
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26303266Abedin 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.
PubMed 28126155Adarmouch 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.
PubMed 29067251Armstrong 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.
PubMed 28614678Bilandzic 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.
PubMed 28273040Bowen 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.
PubMed 19362699Bus 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.
PubMed 26452160Dorresteijn 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.
PubMed 25514250Fan 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.
PubMed 23823459Frykberg 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.
PubMed 17280936Gershater MA, Pilhammar E, Apelqvist J, Alm-Roijer C. Patient education for the prevention of diabetic foot ulcers. European Diabetes Nursing. 2011: 8: 102-107b.
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.
PubMed 24922170Jeffcoate 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.
PubMed 28911921Jeffcoate 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.
PubMed 29559450Lincoln 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.
PubMed 18758747
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Facebook Group-based Program for Foot Self-management Support of Adults With Diabetes Mellitus: A Feasibility Study in Canada
- ClinicalTrials.gov ID
- NCT04395521
- Acronym / sponsor ID
- 6029718
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Patient education, Foot self-care, Foot self-care adherence, Social media, Self-management support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Helen ObilorUniversity, hospital or other
- Collaborators
- Wounds Canada
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Access to a diabetic foot self-management support program via a Facebook group platform for 3 months.
| Arm | Type | Receives |
|---|---|---|
| Facebook group arm | Experimental | Behavioral: Diabetic foot self-management supportAccess to a diabetic foot self-management support program via a Facebook group platform for three months plus the standard care. |
| Standard care arm | No intervention | –Carry on with the routine diabetes care offered to the participants in their health facilities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Declined consent
- Did not provide follow-up contact information
- Completed less than 60% of the baseline survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetic foot self-management supportDaily educational organic or inorganic posts (2 to 5) released in a timed sequence through a Hootsuite application plus peer interactions/support for three months. | Behavioural | Facebook group arm |
Primary outcome
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.
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.
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.
5 secondary outcomes
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).
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Background: PubMed 26303266Abedin 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.
- Background: PubMed 28126155Abedin 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.
- Background: PubMed 29067251Adarmouch 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.
- Background: PubMed 28614678Armstrong 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.
- Background: PubMed 28273040Bilandzic 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.
- Background: PubMed 19362699Bowen 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.
- Background: PubMed 26452160Bus 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.
- Background: PubMed 25514250Dorresteijn 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.
- Background: PubMed 23823459Fan 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.
- Background: PubMed 17280936Frykberg 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.
- BackgroundGershater MA, Pilhammar E, Apelqvist J, Alm-Roijer C. Patient education for the prevention of diabetic foot ulcers. European Diabetes Nursing. 2011: 8: 102-107b.
- Background: PubMed 24922170Grady 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.
- Foundations of best practice for skin and wound management: Best practice recommendations for the prevention and management of diabetic foot ulcersLink provided by the sponsor.
- The economic impact of offloading devices for the prevention of amputations in Ontario.Link provided by the sponsor.
- Share of U.S. adults using social media, including Facebook, is mostly unchanged since 2018Link provided by the sponsor.
- Clinical best practice guidelines: Assessment and management of foot ulcers for people with diabetes.Link provided by the sponsor.
- IWGDF Practical Guidelines on the Prevention and Management of Diabetic Foot Disease.Link provided by the sponsor.
- Most popular social networks worldwide as of October 2019, ranked by number of active users.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen N Obilor, MSc. principal investigator
Faculty of Health Sciences\School of Nursing, Queen's University
Kevin Woo, Ph.D. study director
Faculty of Health Sciences\School of Nursing, Queen's University
Rosemary Wilson, Ph.D. study director
Faculty of Health Sciences\School of Nursing, Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetic foot self-management support in people with Diabetic Foot Ulcer, run by Helen Obilor at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants that accepted the intervention. (time frame: Four weeks after the commencement of intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04395521, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.