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

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          Abstract

          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.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s13063-022-07027-9.

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          Most cited references25

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          IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045

          To provide global, regional, and country-level estimates of diabetes prevalence and health expenditures for 2021 and projections for 2045.
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            How to Calculate Sample Size for Different Study Designs in Medical Research?

            Calculation of exact sample size is an important part of research design. It is very important to understand that different study design need different method of sample size calculation and one formula cannot be used in all designs. In this short review we tried to educate researcher regarding various method of sample size calculation available for different study designs. In this review sample size calculation for most frequently used study designs are mentioned. For genetic and microbiological studies readers are requested to read other sources.
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              2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes—2019

              (2018)
              The American Diabetes Association (ADA) "Standards of Medical Care in Diabetes" includes ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations, please refer to the Standards of Care Introduction Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.
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                Author and article information

                Contributors
                hosseinishirin@ymail.com
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                28 December 2022
                28 December 2022
                2022
                : 23
                : 1056
                Affiliations
                [1 ]GRID grid.412237.1, ISNI 0000 0004 0385 452X, Student Research Committee, , Hormozgan University of Medical Sciences, ; Bandar Abbas, Iran
                [2 ]GRID grid.412237.1, ISNI 0000 0004 0385 452X, Social Determinants in Health Promotion Research Center, , Hormozgan Health Institute, Hormozgan University of Medical Sciences, ; Bandar Abbas, Iran
                [3 ]GRID grid.412237.1, ISNI 0000 0004 0385 452X, Cardiovascular Research Center, , Hormozgan University of Medical Sciences, ; Bandar Abbas, Iran
                Article
                7027
                10.1186/s13063-022-07027-9
                9795658
                36578044
                bf6cc792-3047-4d10-b145-017871491d5f
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 28 August 2022
                : 15 December 2022
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100011917, Hormozgan University of Medical Sciences;
                Award ID: 4000362
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2022

                Medicine
                type 2 diabetes mellitus,treatment adherence,mixed method study
                Medicine
                type 2 diabetes mellitus, treatment adherence, mixed method study

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