Diabetes Foot Care Clinical Trial
Official title:
Feasibility of Virtual Simulation-Based Diabetes Foot Care Education in Patients With Diabetes in Ethiopia
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?
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | December 15, 2024 |
| Est. primary completion date | December 15, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Ethiopia | University of Gondar Referral Hospital | Gondar | Amhara |
| Lead Sponsor | Collaborator |
|---|---|
| Fisseha Z Amdie |
Ethiopia,
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. — View Citation
Aklilu 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. — View Citation
Angamo 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. — View Citation
Aschalew 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. — View Citation
Beran 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. — View Citation
Billingham 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. — View Citation
Boren 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. — View 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. — View Citation
Chali 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. — View Citation
Cho 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. — View Citation
Dettori 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. — View Citation
Diabetes Canada Clinical Practice Guidelines Expert Committee; Embil JM, Albalawi Z, Bowering K, Trepman E. Foot Care. Can J Diabetes. 2018 Apr;42 Suppl 1:S222-S227. doi: 10.1016/j.jcjd.2017.10.020. No abstract available. — View Citation
Dube 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. — View Citation
Edelman 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. — View Citation
Eldridge 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. — View Citation
Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008 Apr;62(1):107-15. doi: 10.1111/j.1365-2648.2007.04569.x. — View Citation
Foronda CL, Fernandez-Burgos M, Nadeau C, Kelley CN, Henry MN. Virtual Simulation in Nursing Education: A Systematic Review Spanning 1996 to 2018. Simul Healthc. 2020 Feb;15(1):46-54. doi: 10.1097/SIH.0000000000000411. — View Citation
Gudina EK, Amade ST, Tesfamichael FA, Ram R. Assessment of quality of care given to diabetic patients at Jimma University Specialized Hospital diabetes follow-up clinic, Jimma, Ethiopia. BMC Endocr Disord. 2011 Dec 20;11:19. doi: 10.1186/1472-6823-11-19. — View Citation
Indrayana S, Guo SE, Lin CL, Fang SY. Illness Perception as a Predictor of Foot Care Behavior Among People With Type 2 Diabetes Mellitus in Indonesia. J Transcult Nurs. 2019 Jan;30(1):17-25. doi: 10.1177/1043659618772347. Epub 2018 Apr 26. — View Citation
Johnson C, Feenan K, Setliff G, Pereira K, Hassell N, Beresford HF, Epps S, Nicollerat J, Tatum W, Feinglos M, Vorderstrasse A. Building a Virtual Environment for Diabetes Self-Management Education and Support. Int J Virtual Communities Soc Netw. 2013;5(3):111359. doi: 10.4018/ijvcsn.2013070105. — View Citation
Kasiya MM, Mang'anda GD, Heyes S, Kachapila R, Kaduya L, Chilamba J, Goodson P, Chalulu K, Allain TJ. The challenge of diabetic foot care: Review of the literature and experience at Queen Elizabeth Central Hospital in Blantyre, Malawi. Malawi Med J. 2017 Jun;29(2):218-223. doi: 10.4314/mmj.v29i2.26. No abstract available. — View Citation
Lateef F. Simulation-based learning: Just like the real thing. J Emerg Trauma Shock. 2010 Oct;3(4):348-52. doi: 10.4103/0974-2700.70743. — View Citation
Luctkar-Flude M, Tyerman J, Ziegler E, Carroll B, Shortall C, Chumbley L, Tregunno D. Developing a Sexual Orientation and Gender Identity Nursing Education Toolkit. J Contin Educ Nurs. 2020 Sep 1;51(9):412-419. doi: 10.3928/00220124-20200812-06. — View Citation
McInnes A, Jeffcoate W, Vileikyte L, Game F, Lucas K, Higson N, Stuart L, Church A, Scanlan J, Anders J. Foot care education in patients with diabetes at low risk of complications: a consensus statement. Diabet Med. 2011 Feb;28(2):162-7. doi: 10.1111/j.1464-5491.2010.03206.x. — View Citation
Petit dit Dariel OJ, Raby T, Ravaut F, Rothan-Tondeur M. Developing the Serious Games potential in nursing education. Nurse Educ Today. 2013 Dec;33(12):1569-75. doi: 10.1016/j.nedt.2012.12.014. Epub 2013 Jan 16. — View Citation
Sari Y, Upoyo AS, Isworo A, Taufik A, Sumeru A, Anandari D, Sutrisna E. Foot self-care behavior and its predictors in diabetic patients in Indonesia. BMC Res Notes. 2020 Feb 1;13(1):38. doi: 10.1186/s13104-020-4903-y. — View Citation
Torgerson DJ, Roberts C. Understanding controlled trials. Randomisation methods: concealment. BMJ. 1999 Aug 7;319(7206):375-6. doi: 10.1136/bmj.319.7206.375. No abstract available. — View Citation
Verkuyl M, Hughes M, Tsui J, Betts L, St-Amant O, Lapum JL. Virtual Gaming Simulation in Nursing Education: A Focus Group Study. J Nurs Educ. 2017 May 1;56(5):274-280. doi: 10.3928/01484834-20170421-04. — View Citation
Worku 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. — View Citation
Zhang Y, Liu C, Luo S, Xie Y, Liu F, Li X, Zhou Z. Factors Influencing Patients' Intentions to Use Diabetes Management Apps Based on an Extended Unified Theory of Acceptance and Use of Technology Model: Web-Based Survey. J Med Internet Res. 2019 Aug 13;21(8):e15023. doi: 10.2196/15023. — View Citation
* Note: There are 30 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | One week after the commencement of intervention. | |
| Primary | 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. | One week after the commencement of intervention. | |
| Secondary | 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. | Baseline and week one. | |
| Secondary | 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. | Baseline and week one. | |
| Secondary | 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. | Baseline and week one. |