Description

This study is a mixed-methods study incorporating a cluster randomized controlled trial and a qualitative component. The quantitative component will evaluate the effectiveness of an Information-Motivation-Behavioral Skills (IMB) Model-guided health literacy intervention on medication adherence among non-adherent adults with hypertension.

The quantitative component will be conducted in eight public hospitals in North Ethiopia. Four hospitals will be allocated to the intervention group and four hospitals to the usual-care control group. Eligible adults with hypertension who meet the study criteria for medication non-adherence will be enrolled and followed according to the study protocol.

The intervention is guided by the Information-Motivation-Behavioral Skills Model. The information component will provide understandable and culturally appropriate information about hypertension, antihypertensive medications, medication adherence, and hypertension self-management. The motivation component will address personal and social factors influencing medication-taking behavior and provide appropriate motivational support. The behavioral skills component will focus on practical skills for establishing medication-taking routines, using reminders, addressing barriers to adherence, managing medication-related difficulties, problem-solving, and developing appropriate hypertension self-management strategies.

Participants in intervention hospitals will receive the IMB Model-guided health literacy intervention in addition to usual care. Participants in control hospitals will receive usual care provided by the participating health facilities. The intervention will be delivered according to the study protocol and standardized intervention materials, with appropriate procedures for monitoring intervention fidelity.

The primary quantitative outcome is medication adherence. Medication adherence will be assessed using the instrument and outcome definition specified in the approved study protocol. Blood pressure control will be assessed as a secondary outcome using standardized blood pressure measurement procedures. Other secondary outcomes will include the additional outcomes specified in the study protocol.

The qualitative component will explore the perceptions, experiences, and contextual barriers of medication non-adherent hypertensive patients regarding the information, motivation, and behavioral skills that influence medication adherence and hypertension self-care behaviors. The qualitative component will examine participants' understanding and experiences related to hypertension and antihypertensive medications, their sources of information, personal and social motivation for medication-taking, behavioral skills related to medication adherence and hypertension self-management, and contextual barriers that may influence these factors. It will also explore participants' experiences and perspectives regarding the challenges they face in maintaining medication adherence and hypertension self-care behaviors.

Qualitative data will be collected from purposively selected medication non-adherent hypertensive patients according to the qualitative component of the study protocol. The interviews will provide an in-depth understanding of the factors influencing medication-taking and hypertension self-care behaviors from the participants' perspectives. Qualitative data will be analyzed using an appropriate analysis approach, with findings organized around the information, motivation, behavioral skills, and contextual factors identified in the qualitative objective.

Data collection for both components will follow standardized procedures. Quantitative data will be collected by trained data collectors, and appropriate measures will be taken to maintain data quality and participant confidentiality. Qualitative interviews will be conducted by appropriately trained researchers, documented, transcribed, and analyzed according to the study protocol. Findings from the qualitative component will be considered alongside the quantitative findings to provide contextual understanding of medication adherence and hypertension self-care behaviors among medication non-adherent hypertensive patients.

The primary quantitative hypothesis is that participants receiving the IMB Model-guided health literacy intervention will demonstrate improved medication adherence compared with participants receiving usual care. The qualitative component will complement the quantitative findings by providing contextual information about participants' perceptions, experiences, and barriers related to information, motivation, and behavioral skills that influence medication adherence and hypertension self-care behaviors.