Student Research Committee, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
Social Determinants in Health Promotion Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
Trials. 2022 Dec 28;23(1):1056. doi: 10.1186/s13063-022-07027-9.
Type 2 diabetes (T2D) mellitus treatment as a chronic disease requires adequate adherence to treatment including controlling blood glucose levels and lifestyle management. The aim of this study is to investigate the factors affecting of adherence to T2D treatment from the perspective of patients and design an intervention program based on Pender's health promotion model (HPM) to increase T2D treatment adherence in Bandar Abbas, a city located in the south of Iran.
This mixed method study will consist of qualitative stage, questionnaire design and a randomized, open-label, parallel-group interventional study based on HPM in southern Iran. Sampling for qualitative stage will continue until reaching the saturation. In the intervention stage, participants will be 166 T2D patients referring to the Bandar Abbas Diabetes Clinic will be randomized into intervention and control groups (allocation 1:1). After identifying the factors affecting adherence to treatment in T2D patients by qualitative study and literature review, a questionnaire based on HPM will be designed. In the next stage, 10 sessions of intervention for the intervention group will be designed. To evaluate the effect of the intervention, intervention and control groups will be tested for hemoglobin A1c (HbA1c) before and 3 months after the intervention.
This designed study is a program for improving treatment adherence in T2D based on the HPM model and contributes to a better understanding of effective factors in adherence to treatment in T2D patients. The results of this project can be used for macro-diabetic planning.
This study is registered on the Iranian Registry of Clinical Trials (IRCT20211228053558N1: https://www.irct.ir/trial/61741 ) and first release date of 17th March 2022.
2 型糖尿病（T2D）的治疗作为一种慢性病，需要患者充分遵医嘱进行治疗，包括控制血糖水平和生活方式管理。本研究旨在从患者角度探讨影响 T2D 治疗依从性的因素，并基于 Pender 的健康促进模式（HPM）设计干预方案，以提高伊朗南部城市阿巴斯港 T2D 患者的治疗依从性。
本混合方法研究将包括定性阶段、问卷设计和基于 HPM 的随机、开放标签、平行组干预研究。定性阶段的抽样将持续到达到饱和。在干预阶段，将对 166 名来自阿巴斯港糖尿病诊所的 T2D 患者进行随机分组，分为干预组和对照组（分配比为 1:1）。通过定性研究和文献回顾确定影响 T2D 患者治疗依从性的因素后，将设计基于 HPM 的问卷。在下一阶段，将为干预组设计 10 次干预。为了评估干预的效果，将在干预前和干预后 3 个月对干预组和对照组进行血红蛋白 A1c（HbA1c）检测。
本设计研究是基于 HPM 模型提高 T2D 治疗依从性的方案，有助于更好地理解 T2D 患者治疗依从性的有效因素。该项目的结果可用于宏观糖尿病规划。
本研究在伊朗临床试验注册中心（IRCT20211228053558N1：https://www.irct.ir/trial/61741）注册，首次发布日期为 2022 年 3 月 17 日。
