Development and evaluation of a culturally tailored education module for type 1 diabetes in a resource-constrained setting: protocol for a mixed-methods study
Background: Diabetes education is the key to successful diabetes management. There is a need for an education module for type 1 diabetes (T1D) that is culture-specific and suited to resource constraints.
Methods: A mixed-methods study will be conducted, in three phases, to develop and evaluate a culturally tailored diabetes education module for Indian children with T1D and their families. During the first phase, a qualitative study among health professionals and families of children with T1D for need assessment will be conducted. During the second phase, based on the themes from the last phase, an educational module will be developed. The third phase will involve an evaluation of the content, feasibility and effectiveness of the proposed module. The content evaluation will be done using the standardized 'suitability assessment of materials' checklist. For feasibility, a mixed-method approach will be used with iterative cycles of satisfaction scale, semi-structured interview and feasibility and observation checklist. The module will be revised after each cycle till no new changes are suggested. The effectiveness will be assessed by a quasi-experimental controlled trial assessing glycemic control, health-related quality of life, clinically important events and self-management practices in T1D children at baseline and three and six months.
Conclusions: This study aims at development and validation of a novel culturally tailored diabetes education module for children with T1D, suited to their resource constraints. A module designed with the inputs from all stakeholders, and evaluated using iterative cycles, has the potential to suit the dynamic nature of diabetes management in children.
Trial registration: Trial registration number is CTRI/2021/04/032739.
Phelan H, Lange K, Cengiz E, Gallego P, Majaliwa E, Pelicand J, et al. ISPAD clinical practice consensus guidelines 2018: diabetes education in children and adolescents. Pediatr Diabetes. 2018;19(27):75-83.
American Diabetes Association. Children and adolescents: standards of medical care in diabetes-2018. Diabetes Care. 2018;41(1):126-36.
Döğer E, Bozbulut R, Acar ASS, Ercan Ş, Uğurlu AK, Akbaş ED, et al. Effect of telehealth system on glycemic control in children and adolescents with type 1 diabetes. J Clin Res Pediatr Endocrinol. 2019;11(1):70-5.
Kichler JC, Seid M, Crandell J, Maahs DM, Franziska K, Driscoll KA, et al. The Flexible Lifestyle Empowering Change (FLEX) Intervention for self-management in adolescents with Type 1 Diabetes: Trial design and baseline characteristics. Contemp Clin Trials. 2019;66:64-73.
Sundberg F, Barnard K, Cato A, deBeaufort C, DiMeglio LA, Dooley G, et al. Managing diabetes in preschool children. Pediatr Diabetes. 2017;18(7):499-517.
Virmani A. Type 1 diabetes in India : the numbers show the way ahead. Indian Pediatrics. 2019;56(3):189-90.
Grey M. Interventions for children with diabetes and their families. Annu Rev Nurs Res. 2000;18:149-70.
Hilliard ME, Tully C, Monaghan M, Wang J, Streisand R. Design and development of a stepped-care behavioral intervention to support parents of young children newly diagnosed with type 1 diabetes. Contemp Clin Trials. 2017;62:1-10.
Chatterjee S, Davies MJ, Heller S, Speight J, Snoek FJ, Khunti K. Diabetes structured self-management education programmes: a narrative review and current innovations. Lancet Diabetes Endocrinol. 2018;6(2):130-42.
Teft G. Numeracy skills in people with diabetes. Diabet Prim Care. 2015;17(5):218-20.
Wangnoo SK, Maji D, Das AK, Rao P V, Moses A, Sethi B, et al. Barriers and solutions to diabetes management : an Indian perspective. Indian J Endocr Metab. 2013;17(4):594-601.
Bhatia V, Arya V, Dabadghao P, Balasubramanian K, Sharma K, Verghese N, et al. Etiology and Outcome of Childhood and Adolescent Diabetes Mellitus in North India. J Pediatr Endocrinol Metab. 2004;17(7):993-9.
Povlsen L, Olsen B, Ladelund S. Educating families from ethnic minorities in type 1 diabetes-experiences from a Danish intervention study. Patient Educ Couns. 2005;59(2):164-70.
Kalra S, Sridhar GR, Balhara YPS, Sahay RK, Bantwal G, Baruah MP, et al. National recommendations : psychosocial management of diabetes in India. Indian J Endocrinol Metab. 2020;17(3):376-95.
Basu AM. Health cultural influences care use: two regional groups in India. Stud Fam Plann. 1990;21(5):275-86.
Azami G, Soh KL, Sazlina SG, Salmiah MS, Aazami S, Mozafari M, et al. Developing and validating the educational materials for a nurse-led self-management education in adults with type 2 diabetes. Int J Diabetes Metab. 2019;25(1-2):1-10.
Ahmad B, Ramadas A, Fatt QK, Zain AZM. A pilot study: The development of a culturally tailored Malaysian Diabetes Education Module (MY-DEMO) based on the Health Belief Model. BMC Endocr Disord. 2014;14:31.
Park JS, Ahn CW. Educational program for diabetic patients in Korea-multidisplinary intensive management. Diabetes Res Clin Pract. 2007;77(1):194-8.
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions. Med Res Counc. 2019.
University of Zurich. Fact sheet: How to conduct a focus group discussion (FGD): methodological manual, 2017. Available at: https://doi.org/10.5167 /uzh-150640. Accessed on 21 December 2020.
Sinisterra M, Kelly KP, Shneider C, El-Zein A, Swartwout E, Deyo P, et al. Working toward an mhealth platform for adolescents with type 1 diabetes: focus groups with teens, parents, and providers. Diabetes Educ. 2020;46(5):444-54.
Singh T, Sharma S, Nagesh S. Socio-economic status scales updated for 2017. Int J Res Med Sci. 2017;5(7):3264-7.
Doak C, Doak L, Root J. Teaching patients with low literacy skills. 2nd ed. Philadelphia: J. B. Lippincott; 1996.
Wolff K, Chambers L, Bumol S, White RO, Gregory BP, Davis D, et al. The PRIDE (partnership to improve diabetes education) toolkit: development and evaluation of novel literacy and culturally sensitive diabetes education materials. Diabetes Educ. 2016;42(1):23-33.
Connan V, Marcon MA, Mahmud FH, Assor E, Martincevic I, Bandsma RH, et al. Online education for gluten-free diet teaching: development and usability testing of an e-learning module for children with concurrent celiac disease and type 1 diabetes. Pediatr Diabetes. 2019;20(3):293-303.
Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, et al. How we design feasibility studies. Am J Prev Med. 2009;36(5):452-7.
Brorsson AL, Leksell J, Franko MA, Olinder AL. A person‐centered education for adolescents with type 1 diabetes-a randomized controlled trial. Pediatr Diabetes. 2019;20(7):986-96.
Gupta S, Sharma S, Gohil R, Sachdeva S. Epicollect5: a free, fully customizable mobile-based application for data collection in clinical research. J Postgrad Med Educ Res. 2021;54(4):248-51.
Varni JW, Delamater AM, Hood KK, Raymond JK, Chang NT, Driscoll KA, et al. PedsQL 3.2 diabetes module for children, adolescents, and young adults: Reliability and validity in type 1 diabetes. Diabetes Care. 2018;41(10):2064-71.
Barola A, Tiwari P, Bhansali A, Grover S, Dayal D. Cross‐cultural adaptation and psychometric evaluation of Hindi version of diabetes self‐management profile-self report in Indian type 1 diabetes patients. Pediatr Diabetes. 2021;22(1):101-11.
Awad LA, Elghadban FEE, El-Adham NA. Effect of an intervention program on improving knowledge and self-care practices for diabetic school-age children. Am J Nurs Res. 2019;7(2):199-207.
Magill N, Knight R, McCrone P, Ismail K, Landau S. A scoping review of the problems and solutions associated with contamination in trials of complex interventions in mental health. BMC Med Res Methodol. 2019;19(1):4.