Diabetes Foot CareNCT04841291
Feasibility of Virtual Simulation-Based Diabetes Foot Care Education in Patients With Diabetes in Ethiopia
A study testing Diabetes Foot Care Education (DFCE) in people with Diabetes Foot Care, run by Fisseha Z Amdie at 1 site in Ethiopia.
Trial summary
The primary aim of this study is to evaluate the feasibility of virtual simulation-based diabetes foot care education on foot care knowledge and practice/behaviour. Research Questions The primary question for this study is: Is virtual simulation-based diabetes foot care education a practical and acceptable… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Foot Care
- What is being tested?
- Diabetes Foot Care Education (DFCE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEthiopia
- Study dates
- 25 Jan 2022to 15 Dec 2024
- 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
- Adult patients (18 years of age or older).
- Type II diabetes mellitus patients who are on diabetes follow-up at University of Gondar tertiary referral hospital
Who cannot join
- Patients with type 1 diabetes or gestational diabetes
- Patients who previously attended any form of formal Diabetes Self Management Education (DSME) program /documented/ in the past three months.
- Individuals with documented severe cognitive impairment
- Individuals with documented visual impairment that diminished their ability to navigate the game
- Terminally ill individuals
- Individuals without the ability to read or understand the Amharic consent documentation
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site, 1 recruiting
- Recruiting
University of Gondar Referral Hospital
Gonder, Amhara, 196
Fisseha Zewdu Amdie, Msc., 251-918046567, 18fza@queensu.ca
Fisseha Zewdu Amdie, Msc.
About this study
The primary aim of this study is to evaluate the feasibility of virtual simulation-based diabetes foot care education on foot care knowledge and practice/behaviour.
Research Questions
Read more
The primary question for this study is:
- Is virtual simulation-based diabetes foot care education a practical and acceptable intervention among patients with diabetes in Ethiopia?
The secondary questions are:
- What is the impact of virtual simulation-based diabetes foot care education on diabetes foot self-care knowledge among patients with diabetes mellitus?
- What is the impact of virtual simulation-based diabetes foot care education on diabetes foot self-care behaviour among patients with diabetes mellitus?
- What is the impact of virtual simulation-based diabetes foot care education on diabetes foot self-care efficacy among patients with diabetes mellitus?
- What is the impact of virtual simulation-based diabetes foot care education on diabetes foot health-belief among patients with diabetes mellitus?
- Conditions
- Diabetes Foot Care
- Being tested
- Diabetes Foot Care Education (DFCE)
- Keywords
- Diabetes, Feasibility, Acceptability, Practicability, Foot-Care
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Foot Care Education (DFCE)Behavioural
Virtual simulation-based DFCE sessions on seven topics (the reasons for inspecting one's feet, risk factors and prevention strategies of diabetic foot ulcer, how to wash and moisturize feet, comfortable sock and shoe choices, what to look for, and what to do during feet inspection, how to trim fingernails, and how to maintain foot health) at University of Gondar computer lab for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Simulation-Based Arm | Experimental | Access virtual simulation-based diabetes foot care education once for 30 minutes plus the standard care. Receives: Behavioral: Diabetes Foot Care Education (DFCE) |
| Standard Care Arm | No intervention | Participants will continue utilizing the usual follow-up diabetes care which occurs every month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants who accepted the virtual simulation-based foot care education.
Number of participants who scored 70 and above for the virtual simulation-based foot care education acceptance questionnaire.
Measured: One week after the commencement of intervention.
The number of participants who believed in the practicality of the virtual simulation-based foot care education.
Number of participants who scored 70 and above for the virtual simulation-based foot care education practicality questionnaire.
Measured: One week after the commencement of intervention.
Secondary outcomes (3)
The participants' level of foot self-care knowledge.
Mean change from the baseline in foot self-care knowledge of participants one week after the commencement of the intervention. Diabetes foot self-care knowledge will be assessed with the Foot Care Knowledge (FCK) questionnaire. The Foot Care Knowledge questions evaluate the respondent's foot care knowledge. The maximum possible knowledge score will be 11 and can range from 1 to 11. A higher score means a better foot self-care knowledge.
Measured: Baseline and week one.
The participants' level of foot self-care behavior.
Mean change from the baseline in foot self-care behavior of participants one week after the commencement of the intervention. Diabetes Foot Care Behavior will be assessed with the 15-item Foot Self-Care Behavior Scale (FSCBS). The Foot Self-Care Behavior Scale is a brief self-report questionnaire that measures foot care behavior. Patients will be asked to choose the most suitable response; never (1), rarely (2), sometimes (3), often (4), and always (5) to each question. The score ranged from 15-75 and a higher score indicates a better foot self-care behavior.
Measured: Baseline and week one.
The participants' level of foot self-care efficacy to perform recommended diabetic foot self-care activities.
Mean change from the baseline in foot self-care efficacy of participants one week after the commencement of the intervention. This will be measured with Foot Care Confidence Scale (FCCS). The tool consists of 12 items on a 5-point Likert scale strongly not confident (1), not confident (2), moderately confident (3), confident (4), and strongly confident (5). The score ranged from 12 - 60; a higher score indicates a higher level of diabetes foot self-care efficacy.
Measured: Baseline and week one.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start25 Jan 2022
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Diabetes Foot CareStudies 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 virtual simulation-based diabetes foot care education for once for 30 minutes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fisseha Z Amdie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fisseha Z Amdie, Queen's University
- Investigators
- Fisseha Zewdu Amdie, Msc., Principal investigator, School of Nursing, Queen's UniversityKevin Woo, Ph.D., Study director, School of Nursing, Queen's UniversityMarian Luctkar-Flude, Ph.D., Study director, School of Nursing, Queen's UniversityErna Snelgrove-Clarke, Ph.D., Study director, School of Nursing, Queen's UniversityMona Sawhney, Ph.D., Study director, School of Nursing, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841291
- Sponsor's protocol ID
- 6032644
- Status last verified
- Dec 2023
- First submitted
- 3 Apr 2021
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abate TW, Enyew A, Gebrie F, Bayuh H. Nurses' knowledge and attitude towards diabetes foot care in Bahir Dar, North West Ethiopia. Heliyon. 2020 Nov 23;6(11):e05552. doi: 10.1016/j.heliyon.2020.e05552. eCollection 2020 Nov.
PubMed 33294694Aklilu T, Hiko D, Mohammed MA, Dekema NH. Diabetic Patients' Knowledge of Their Disease, Therapeutic Goals, and Self-management: Association With Goal Attainment at Dessie Referral Hospital, Ethiopia. Ther Innov Regul Sci. 2014 Sep;48(5):583-591. doi: 10.1177/2168479014524960.
PubMed 30231456Worku D, Hamza L, Woldemichael K. Patterns of diabetic complications at jimma university specialized hospital, southwest ethiopia. Ethiop J Health Sci. 2010 Mar;20(1):33-9. doi: 10.4314/ejhs.v20i1.69424.
PubMed 22434958Angamo MT, Melese BH, Ayen WY. Determinants of glycemic control among insulin treated diabetic patients in Southwest Ethiopia: hospital based cross sectional study. PLoS One. 2013 Apr 19;8(4):e61759. doi: 10.1371/journal.pone.0061759. Print 2013.
PubMed 23620789Aschalew AY, Yitayal M, Minyihun A, Bisetegn TA. Self-care practice and associated factors among patients with diabetes mellitus on follow up at University of Gondar Referral Hospital, Gondar, Northwest Ethiopia. BMC Res Notes. 2019 Sep 18;12(1):591. doi: 10.1186/s13104-019-4630-4.
PubMed 31533833Beran D, Yudkin JS. Diabetes care in sub-Saharan Africa. Lancet. 2006 Nov 11;368(9548):1689-95. doi: 10.1016/S0140-6736(06)69704-3.
PubMed 17098088Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.
PubMed 23961782Boren SA, Gunlock TL, Peeples MM, Krishna S. Computerized learning technologies for diabetes: a systematic review. J Diabetes Sci Technol. 2008 Jan;2(1):139-46. doi: 10.1177/193229680800200121.
PubMed 19885190Bowen 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 19362699Chali SW, Salih MH, Abate AT. Self-care practice and associated factors among Diabetes Mellitus patients on follow up in Benishangul Gumuz Regional State Public Hospitals, Western Ethiopia: a cross-sectional study. BMC Res Notes. 2018 Nov 26;11(1):833. doi: 10.1186/s13104-018-3939-8.
PubMed 30477553Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.
PubMed 29496507Dettori J. The random allocation process: two things you need to know. Evid Based Spine Care J. 2010 Dec;1(3):7-9. doi: 10.1055/s-0030-1267062. No abstract available.
PubMed 22956922Dube L, Van den Broucke S, Dhoore W, Kalweit K, Housiaux M. An Audit of Diabetes Self-Management Education Programs in South Africa. J Public Health Res. 2015 Nov 17;4(3):581. doi: 10.4081/jphr.2015.581. eCollection 2015 Nov 17.
PubMed 26753160Edelman SV. Taking Control Of Your Diabetes: An Innovative Approach to Improving Diabetes Care Through Educating, Motivating, and Making the Connection Between Patients and Health Care Providers. Clin Diabetes. 2017 Dec;35(5):333-339. doi: 10.2337/cd17-0090. No abstract available.
PubMed 29263578Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
PubMed 27777223
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Virtual Simulation-Based Diabetes Foot Care Education in Patients With Diabetes in Ethiopia
- ClinicalTrials.gov ID
- NCT04841291
- Acronym / sponsor ID
- 6032644
- Conditions
- Diabetes Foot Care
- Keywords
- Diabetes, Feasibility, Acceptability, Practicability, Foot-Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fisseha Z AmdieUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 12 Apr 2021 (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 aim of this study is to evaluate the feasibility of virtual simulation-based diabetes foot care education on foot care knowledge and practice/behaviour.
Research Questions
The primary question for this study is:
- Is virtual simulation-based diabetes foot care education a practical and acceptable intervention among patients with diabetes in Ethiopia?
The secondary questions are:
- What is the impact of virtual simulation-based diabetes foot care education on diabetes foot self-care knowledge among patients with diabetes mellitus?
- What is the impact of virtual simulation-based diabetes foot care education on diabetes foot self-care behaviour among patients with diabetes mellitus?
- What is the impact of virtual simulation-based diabetes foot care education on diabetes foot self-care efficacy among patients with diabetes mellitus?
- What is the impact of virtual simulation-based diabetes foot care education on diabetes foot health-belief among patients with diabetes mellitus?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Access to virtual simulation-based diabetes foot care education for once for 30 minutes.
| Arm | Type | Receives |
|---|---|---|
| Virtual Simulation-Based Arm | Experimental | Behavioral: Diabetes Foot Care Education (DFCE)Access virtual simulation-based diabetes foot care education once for 30 minutes plus the standard care. |
| Standard Care Arm | No intervention | –Participants will continue utilizing the usual follow-up diabetes care which occurs every month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (18 years of age or older).
- Type II diabetes mellitus patients who are on diabetes follow-up at University of Gondar tertiary referral hospital
Key exclusion criteria (6 listed)
- Patients with type 1 diabetes or gestational diabetes
- Patients who previously attended any form of formal Diabetes Self Management Education (DSME) program /documented/ in the past three months.
- Individuals with documented severe cognitive impairment
- Individuals with documented visual impairment that diminished their ability to navigate the game
- Terminally ill individuals
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 |
|---|---|---|
| Diabetes Foot Care Education (DFCE)Virtual simulation-based DFCE sessions on seven topics (the reasons for inspecting one's feet, risk factors and prevention strategies of diabetic foot ulcer, how to wash and moisturize feet, comfortable sock and shoe choices, what to look for, and what to do during feet inspection, how to trim fingernails, and how to maintain foot health) at University of Gondar computer lab for 30 minutes. | Behavioural | Virtual Simulation-Based Arm |
Primary outcome
The number of participants who accepted the virtual simulation-based foot care education.
Time frame: One week after the commencement of intervention.
Number of participants who scored 70 and above for the virtual simulation-based foot care education acceptance questionnaire.
The number of participants who believed in the practicality of the virtual simulation-based foot care education.
Time frame: One week after the commencement of intervention.
Number of participants who scored 70 and above for the virtual simulation-based foot care education practicality questionnaire.
3 secondary outcomes
The participants' level of foot self-care knowledge.
Time frame: Baseline and week one.
The participants' level of foot self-care behavior.
Time frame: Baseline and week one.
The participants' level of foot self-care efficacy to perform recommended diabetic foot self-care activities.
Time frame: Baseline and week one.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Background: PubMed 33294694Abate TW, Enyew A, Gebrie F, Bayuh H. Nurses' knowledge and attitude towards diabetes foot care in Bahir Dar, North West Ethiopia. Heliyon. 2020 Nov 23;6(11):e05552. doi: 10.1016/j.heliyon.2020.e05552. eCollection 2020 Nov.
- Background: PubMed 30231456Aklilu T, Hiko D, Mohammed MA, Dekema NH. Diabetic Patients' Knowledge of Their Disease, Therapeutic Goals, and Self-management: Association With Goal Attainment at Dessie Referral Hospital, Ethiopia. Ther Innov Regul Sci. 2014 Sep;48(5):583-591. doi: 10.1177/2168479014524960.
- Background: PubMed 22434958Worku D, Hamza L, Woldemichael K. Patterns of diabetic complications at jimma university specialized hospital, southwest ethiopia. Ethiop J Health Sci. 2010 Mar;20(1):33-9. doi: 10.4314/ejhs.v20i1.69424.
- Background: PubMed 23620789Angamo MT, Melese BH, Ayen WY. Determinants of glycemic control among insulin treated diabetic patients in Southwest Ethiopia: hospital based cross sectional study. PLoS One. 2013 Apr 19;8(4):e61759. doi: 10.1371/journal.pone.0061759. Print 2013.
- Background: PubMed 31533833Aschalew AY, Yitayal M, Minyihun A, Bisetegn TA. Self-care practice and associated factors among patients with diabetes mellitus on follow up at University of Gondar Referral Hospital, Gondar, Northwest Ethiopia. BMC Res Notes. 2019 Sep 18;12(1):591. doi: 10.1186/s13104-019-4630-4.
- Background: PubMed 17098088Beran D, Yudkin JS. Diabetes care in sub-Saharan Africa. Lancet. 2006 Nov 11;368(9548):1689-95. doi: 10.1016/S0140-6736(06)69704-3.
- Background: PubMed 23961782Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.
- Background: PubMed 19885190Boren SA, Gunlock TL, Peeples MM, Krishna S. Computerized learning technologies for diabetes: a systematic review. J Diabetes Sci Technol. 2008 Jan;2(1):139-46. doi: 10.1177/193229680800200121.
- 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 30477553Chali SW, Salih MH, Abate AT. Self-care practice and associated factors among Diabetes Mellitus patients on follow up in Benishangul Gumuz Regional State Public Hospitals, Western Ethiopia: a cross-sectional study. BMC Res Notes. 2018 Nov 26;11(1):833. doi: 10.1186/s13104-018-3939-8.
- Background: PubMed 29496507Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.
- Background: PubMed 22956922Dettori J. The random allocation process: two things you need to know. Evid Based Spine Care J. 2010 Dec;1(3):7-9. doi: 10.1055/s-0030-1267062. No abstract available.
- 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.
Fisseha Zewdu Amdie, Msc. principal investigator
School of Nursing, Queen's University
Kevin Woo, Ph.D. study director
School of Nursing, Queen's University
Marian Luctkar-Flude, Ph.D. study director
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 Diabetes Foot Care Education (DFCE) in people with Diabetes Foot Care, run by Fisseha Z Amdie at 1 site in Ethiopia.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Dec 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 Ethiopia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fisseha Zewdu Amdie, Msc. (251-918-046567, 18fza@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants who accepted the virtual simulation-based foot care education. (time frame: One week after the commencement of intervention.). The study lists 2 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 NCT04841291, which also lists 31 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 26 Dec 2023.