An interventional study of IMB Model-Guided Health Education Intervention and Usual Care in Hypertension, sponsored by Bahir Dar University. Recruiting at 8 sites in Ethiopia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Bahir Dar University · Not applicable, Interventional, and Health services research
This study will evaluate the effectiveness of an Information-Motivation-Behavioral Skills (IMB) Model-guided health literacy intervention among adults with hypertension who are non-adherent to prescribed antihypertensive medication. The study will use a cluster randomized controlled trial design in eight public hospitals in North Ethiopia. Four hospitals will be allocated to the intervention group and four to the usual-care control group.
The intervention will address information, motivation, and behavioral skills related to medication adherence and hypertension self-management. Participants in the intervention group will receive the IMB Model-guided health literacy intervention in addition to usual care, while participants in the control group will receive usual care.
The primary outcome is medication adherence. Blood pressure control and other specified hypertension self-management outcomes will be assessed as secondary outcomes. In addition, a 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 their medication adherence and hypertension self-care behaviors.
The study will test the hypothesis that the IMB Model-guided health literacy intervention will improve medication adherence compared with usual care. The qualitative component will provide contextual information to help explain participants' experiences and the factors influencing medication-taking behavior and intervention implementation.
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's planned enrollment of 230 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Bahir Dar University is the lead sponsor of 16 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
1. Severe comorbidities that limit life expectancy or participation
Participants assigned to this arm will receive the Information-Motivation-Behavioral Skills (IMB) Model-guided health education intervention in addition to usual hypertension care.
Behavioral: IMB Model-Guided Health Education Intervention
Participants in the control group will receive the usual hypertension care routinely provided at their respective public hospitals. No additional IMB Model-guided health literacy intervention will be provided during the study period.
Behavioral: Usual Care
Participants allocated to the intervention arm will receive a structured, face-to-face health literacy intervention in addition to usual hypertension care. The intervention will be guided by the IMB model, which posits that health behavior change is determined by adequate information, sufficient personal and the acquisition of relevant behavioral skills. The information component will aim to improve participants' and their significant others' health literacy regarding hypertension and its management. The motivation component will focus on strengthening personal and social motivation for medication adherence and healthy self-care behaviors. The behavioral skills component will aim to equip participants with the practical skills necessary to maintain medication adherence and effectively perform recommended hypertension self-care behaviors.
Participants in the control group will receive the usual hypertension care routinely provided at their respective public hospitals. No additional IMB Model-guided health literacy intervention will be provided during the study period.
Number and proportion of participants adherent to antihypertensive medication, assessed using the four-item Morisky-Green-Levine Medication Adherence Scale
Medication adherence will be assessed using the four-item Morisky-Green-Levine Medication Adherence Scale. Each "Yes" response indicating non-adherent behavior will be scored 1, and each "No" response will be scored 0, yielding a total score ranging from 0 to 4. Participants scoring 0-1 will be classified as adherent, whereas those scoring 2-4 will be classified as non-adherent. The number and proportion of participants classified as adherent will be reported separately for the intervention and usual-care control groups.
Time frame: Baseline and 4 months after the start of the intervention.
Number and Proportion of participants achieving blood pressure control based on systolic and diastolic blood pressure measurements
Blood pressure will be measured using a validated automated digital sphygmomanometer. Participants will sit quietly for at least 5 minutes before measurement, with their back supported, feet flat on the floor, and arm supported at heart level. Measurements will be taken on the right arm using an appropriately sized cuff. Three readings will be obtained at 1-2-minute intervals, and the average of the last two readings will be used for analysis. Participants will be instructed to avoid caffeine, smoking, and physical activity for at least 30 minutes before measurement. Blood pressure control will be defined as systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg. The number and proportion of participants achieving blood pressure control will be reported separately for the intervention and usual-care control groups.
Time frame: Baseline and 4 months after the start of the intervention.
Plan to share: No
Started Jun 2026 (actual). Primary completion is estimated for Mar 2027, 9 months after the start.
Of 1,339 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's planned 9 months is below that.
Counting every sponsor, half of 1,433 studies reached it within 23 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Bahir Dar University