Determinants of treatment adherence to type 2 diabetes mellitus and hypertension in a coastal community A mixed method approach

Objective 1 - Quantitative study: Using convenient sampling method, 415 participants will be recruited into the study. A house-to-house survey will be conducted. The residents diagnosed with T2DM and/or hypertension at least for 1 year present at the time of home visit will be recruited into the study. The purpose of the visit will be explained to the participant using Participant Information Sheet (PIS) which will be handed over to the participant and a written Informed Consent (IC) will be obtained from all the willing participants in the native language before recruiting them into the study. A pre-designed semi structured questionnaire will be administered in each participant to gather data on their socio demographic characteristics, details about substance use, information regarding their health and medications use. Socio economic status will be assessed using Modified BG Prasad Scale 2023. Lifestyle factors such as dietary habits will be assessed according to a survey questionnaire by Kini S et al. The scores will be summed up and categorized as Poor (score 0-33), Satisfactory (score 34-38) and Good (score >38).8 Physical activity will be scored according to a survey questionnaire used by Ramachandran A et al. According to the scores obtained, physical activity will be graded as Sedentary (score 1-17), Light (score 18-34), Moderate (score 35-51) and Heavy Physical activity (score >51).9 Stress will be assessed using Cohen’s Perceived Stress Scale 4 (PSS 4). Higher score indicates more perceived stress. 10 Morisky Medication Adherence Scale-8 (MMAS-8) will be used to assess treatment adherence to type 2 diabetes mellitus and hypertension. It is an adherence scale consisting of 8 questions. Out of which 7 items will be answered with a yes or no and 1 item will be a 5-point Likert scale. The scores of the MMAS-8 range from 0 to 8. A score below 6 indicates low adherence, a score between 6 < 8 medium adherence and a score of 8 high adherence. Due permissions will be obtained for use of all study tools. Anthropometric measurements (Height, Weight, Waist circumference) will be measured as per standard WHO protocol. Blood Pressure (BP) will be recorded using a digital sphygmomanometer and classified as per JNC-8 classification.13 Random Blood Sugar (RBS) will be measured using a glucometer. RBS>200 mg/dL will be considered as poor disease control.

Objective 2 - Qualitative study: By purposive sampling method, 12-15 participants will be requested to participate for In-Depth Interview (IDI). 3 participants each diagnosed with type 2 diabetes mellitus and/or hypertension who are adherent to treatment. 3 participants each diagnosed with type 2 diabetes mellitus and/or hypertension who are non-adherent to treatment. The interviews will be conducted at a place & time convenient to participants. An interview guide will be designed to explore the factors of adherence and non-adherence to type 2 diabetes mellitus and hypertension treatment. The interview guide will be constructed to broadly explore the perception of participants about various factors related to treatment adherence and non-adherence. Probes will be used in the interview guide to get the relevant information from the participant. The face-to-face interview will be recorded using a voice recorder. Each session may last up to 30 - 60 mins. Consent for audio recording of the interview will be obtained prior to the IDI. Confidentiality of the data will be maintained throughout the study.

Objective 3 – Scoping Review. The review will be conducted based on a review framework by Arskey & O’Malley, 2005.7 A search strategy will be run through various databases (PubMed, Medline, Embase, Scopus). Identified studies will be selected for the review after following all the steps using the software – Rayyan with two reviewers. Duplication removal, Title/Abstract screening, Full text screening using the PRISMA guidelines will be done. Conflicts will be resolved by the subject expert. Data Extraction and a thematic analysis will be conducted.

a) Inclusion and exclusion criteria:

Objective 1 & 2

1. Inclusion criteria: Permanent residents aged 30 years or above diagnosed with type 2 diabetes mellitus and/or hypertension at least for 1 year.

2. Exclusion criteria: Patients who are unable to provide answers to the questionnaire.

Biological material: Blood (1-2 drops of blood) for assessing Random Blood Sugar.

b) Statistical methods

Objective 1 -Quantitative: Data will be entered and analyzed using Jamovi Version 2.4.11.0. Data will be presented as percentages & proportions. Chi square test will be used to study association of Diabetes and Hypertension treatment adherence with control of the disease and odd’s ratio to study the strength of association. Multivariable logistic regression will be used to identify individual risk factors.

Objective 2 - Qualitative: After interview, the recorded interviews will be translated & transcribed. Data will be indexed according to the identified themes and sub-themes which allows clarification for the final framework and chart according to each theme to synthesize the data and aid interpretation.

Objective 3 - The review will be conducted based on a review framework by Arskey & O’Malley, 2005.7 Full text screening using the PRISMA guidelines will be done. Conflicts will be resolved by the subject expert. Data Extraction and a thematic analysis will be conducted.