Application of Pender's health promotion model for type 2 diabetes treatment adherence: protocol for a mixed methods study in southern Iran.

Background: 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.

Methods: 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.

Discussion: 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.

Trial Registration: 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.