Clinical Trials in Degenerative Diseases

RESEARCH ARTICLE
Year
: 2019  |  Volume : 4  |  Issue : 3  |  Page : 65--69

A study protocol on effectiveness of theory-based intervention on self-care and glycated hemoglobin among type 2 diabetes patients in National Center for Diabetes in Yemen


Abeer Yahya Ahmed Al-Washali1, Abdul Rahman Hejar1, Kadri Shahar Hayati1, Ismail Suriani1, Yahya A Elezzy2 
1 Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia 43000 UPM Serdang, Selangor, Malaysia
2 Faculty of Medicine, Sana’a University, Head of Medical Department, Al Thawra General Teaching Hospital, Sana’a, Yemen

Correspondence Address:
Abeer Yahya Ahmed Al-Washali
Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia 43000 UPM Serdang, Selangor
Malaysia

Background and objectives: Diabetes is a complex, chronic illness that needs unceasing medical care with multifactorial risk-reduction strategies. Adequate glycemic control is recommended to reduce diabetes complication. Adequate self-care is important to improve glycemic control. Despite the importance of glycemic control, the majority of diabetic patients in Yemen have poor glycemic control. Poor glycemic control is a sign of poor self-care behaviors. Inadequate self-care increases patient’s morbidity and mortality, costs of medication and laboratory tests and cost in time and effort of care providers. The purpose of this study was to develop, implement, and evaluate the effect of Information-Motivation-Behavioral Skills (IMB) model-based Diabetes Self-Management on diabetes self-care behaviors (diet, physical activity, and foot care) and glycated hemoglobin among patients with type 2 diabetes in the National Center for Diabetes in Yemen. Subjects and methods: This is a parallel-randomized controlled trial, which will be conducted at the National Center of Diabetes in Yemen. Eligible participants who give consent will be randomized to an intervention group and a control group (usual care) after baseline assessment. The intervention group will receive the intervention, which is a 3-hour session, based on the information motivation behavioral skills model to improve the self-care behaviors (diet, physical activity, and foot care) and glycated hemoglobin. A post-intervention assessment will be done at 6 months after the intervention. Patient recruitment began in February, 2018. Analysis of primary outcome measure will be completed in July 2019, and the study will be finished in September 2019. Study protocol: 1.0. The protocol was approved by the Ethics Committee for Research Involving Human Subjects from Universiti Putra Malaysia on February 7, 2017 (reference No. FPSK (FR16) 015) and Al Thawra Hospital Ethics Committee (reference No. 2/2018). Outcome measures: The primary outcomes of this study are the changes in diabetes self-care behaviors (diet, physical activity, foot care) and glycated hemoglobin. The secondary outcomes are the changes in information motivation and behavioral skills of diet, physical activity, and foot care. Discussion: This theory-based randomized controlled trial aims to improve the glycemic control of patients with type 2 diabetes through improving the adherence to diabetes self-care behaviors. Trial registration: This trial was registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) (registration number: ACTRN12617001037392) on July 17, 2017. http://www.anzctr.org.au/ACTRN12617001037392.aspx


How to cite this article:
Al-Washali AY, Hejar AR, Hayati KS, Suriani I, Elezzy YA. A study protocol on effectiveness of theory-based intervention on self-care and glycated hemoglobin among type 2 diabetes patients in National Center for Diabetes in Yemen.Clin Trials Degener Dis 2019;4:65-69


How to cite this URL:
Al-Washali AY, Hejar AR, Hayati KS, Suriani I, Elezzy YA. A study protocol on effectiveness of theory-based intervention on self-care and glycated hemoglobin among type 2 diabetes patients in National Center for Diabetes in Yemen. Clin Trials Degener Dis [serial online] 2019 [cited 2019 Dec 16 ];4:65-69
Available from: http://www.clinicaltdd.com/article.asp?issn=2542-3975;year=2019;volume=4;issue=3;spage=65;epage=69;aulast=Al-Washali;type=0