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Clinical Trials/NCT07307924
NCT07307924Enrolling By InvitationNot Applicable

The Effect of Motivational Interviewing on Knowledge, Self-Efficacy, and Treatment Adherence in Patients With Primary Hypertension Living in Semi-Rural Areas: A Randomized Controlled Trial

Eskisehir Osmangazi University2 sites in 1 country100 target enrollmentStarted: December 30, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
100
Locations
2
Primary Endpoint
The knowledge levels of individuals in the intervention group demonstrate a significant increase after the training compared with those in the control group.

Study Overview

Brief Summary

This study is a single-center, single-blind, parallel-group randomized controlled trial designed to examine the impact of a Health Belief Model (HBM)-based motivational interviewing (MI) intervention on knowledge level, self-efficacy, and treatment adherence among primary hypertension patients living in a semi-rural region. Hypertension, despite its typically asymptomatic course, is a prevalent chronic condition that contributes significantly to cardiovascular morbidity and mortality. Poor adherence to treatment and insufficient disease-related knowledge remain major barriers to achieving optimal blood pressure control. Self-efficacy is recognized as a crucial psychological determinant influencing lifestyle modification and medication adherence, and theoretical models-particularly the HBM-provide a structured framework for understanding individuals' health perceptions and facilitating behavioral change.

Motivational interviewing, a patient-centered counseling method aimed at strengthening intrinsic motivation, is thought to be particularly effective when combined with the HBM. The integration of these two approaches is expected to enhance individuals' readiness for change and promote active engagement in treatment. Existing evidence indicates that MI-based interventions can improve medication adherence, encourage lifestyle modifications, increase self-efficacy, and support better blood pressure control. These findings form the conceptual basis of the present study.

The trial was conducted between November 2025 and April 2026 at Hisarardı Family Health Center in Simav, Kütahya. The target population consisted of 140 individuals diagnosed with primary hypertension. Using G*Power with an effect size of 0.60, 80% power, and α=0.05, the required sample size was calculated as 50 participants per arm. Stratified randomization by sex and block randomization with blocks of four were employed.

The intervention group received a four-session MI program structured according to the HBM, consisting of the following components:

Enhancing risk perception and awareness of disease severity Highlighting treatment benefits and reducing perceived barriers Strengthening self-efficacy and developing a personalized action plan Strategies for maintaining behavioral change and identifying cues to action Each session lasted 30-45 minutes and was delivered biweekly. Participants in the control group did not receive any educational intervention and continued with routine clinical follow-up only.

Data were collected using the following instruments:

Hypertension Knowledge Level Scale Hill-Bone Medication Adherence Scale Hypertension Self-Efficacy Scale Systolic and diastolic blood pressure measurements Assessments were conducted at baseline (0 month), mid-intervention (3 months), and at the end of follow-up (6 months). Statistical analyses will be performed using SPSS 26.0, including paired and independent sample tests, correlation analyses, and effect size calculations.

Ethics approval, institutional permissions, and scale-use authorizations were obtained prior to data collection, and all procedures were carried out in accordance with the Declaration of Helsinki.

This study is expected to offer valuable insights into the applicability of theory-driven educational interventions in primary care settings, clarify the contribution of motivational interviewing to hypertension management, and inform national initiatives such as the Disease Management Platform (HYP).

Detailed Description

Hypertension is a chronic condition characterized by persistently elevated arterial blood pressure. It is clinically defined as a systolic blood pressure of ≥140 mmHg and/or diastolic pressure of ≥90 mmHg. The Turkish Society of Hypertension and Kidney Diseases (THBHD) emphasizes that hypertension often progresses silently without overt symptoms, yet over time it can lead to serious complications such as cardiovascular disease, stroke, renal failure, and other forms of target-organ damage.

Globally, hypertension is among the most prevalent chronic diseases and remains one of the leading contributors to cardiovascular morbidity and mortality. According to the World Health Organization, one in every three adults worldwide is living with hypertension. In Türkiye, the prevalence among adults aged 30-79 years is estimated at approximately 32%. Similarly, Şengül et al. reported a national prevalence of 30.3%.

Long-term hypertension management is closely linked to individuals' capacity to engage in lifestyle modifications, adhere to pharmacological treatment, and effectively self-manage their condition. However, numerous studies indicate that poor adherence to antihypertensive therapy and insufficient disease-related knowledge hinder optimal blood pressure control. These findings underscore the importance of understanding the beliefs and perceptions that shape individuals' health behaviors and developing structured educational models tailored to these determinants.

Self-efficacy, a key psychological construct in behavior change and chronic disease management, refers to an individual's belief in their ability to successfully perform a desired behavior. Evidence suggests that self-efficacy plays a central role in maintaining blood pressure control by enhancing medication adherence, reducing dietary sodium intake, supporting adherence to the DASH diet, promoting regular physical activity, and ensuring consistent blood pressure monitoring. Successful chronic disease management requires more than pharmacotherapy; individuals' disease perceptions, treatment attitudes, and health-related behaviors directly influence clinical outcomes.

Studies on chronic diseases such as hypertension demonstrate that individuals with strong self-efficacy are more committed to medication adherence, regular exercise, dietary adjustments, and self-monitoring behaviors. Accordingly, theoretical models that systematically explain health behaviors serve as valuable tools for guiding behavioral interventions. One such model, the Health Belief Model (HBM), conceptualizes individuals' perceptions of disease risk and the factors influencing engagement in health-promoting behaviors. The model comprises six constructs: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy. Structured interventions based on these constructs have been shown to positively influence health behaviors and improve chronic disease outcomes, including in hypertension management.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Masking Description

In this study, participants were blinded to their assignment to the intervention or control group, thereby ensuring a single-blind design. As the research was conducted as part of a doctoral dissertation, the investigator personally carried out both the data collection procedures and the delivery of the intervention. For this reason, blinding during the implementation phase was not feasible. Nevertheless, to minimize potential bias, data entry and all statistical analyses were performed independently and in a blinded manner by a statistician who was not involved in any other stage of the study.

Eligibility Criteria

Ages
25 Years to 59 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Being diagnosed with primary hypertension,
  • Being between 25 and 59 years of age,
  • Having had a confirmed primary hypertension diagnosis for at least 12 months,
  • Being literate and able to communicate in Turkish,
  • Voluntarily agreeing to participate in the study.

Exclusion Criteria

  • Having cognitive impairment, dementia, or a severe psychiatric diagnosis,
  • Having a diagnosis of secondary hypertension,
  • Being pregnant or in the breastfeeding period,
  • Having a physical disability or communication problem that would prevent active participation in the educational sessions.

Outcomes

Primary Outcomes

The knowledge levels of individuals in the intervention group demonstrate a significant increase after the training compared with those in the control group.

Time Frame: March 2026 (3 months later)

The knowledge levels of individuals in the intervention group show a significant increase after the training compared with those in the control group.

The knowledge levels of individuals in the intervention group increase significantly after the training compared with those in the control group.

Time Frame: June 2026 (6 months after onset)

The knowledge levels of individuals in the intervention group show a significantly greater increase after the training compared with those in the control group.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Eskisehir Osmangazi University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Şenay ÖZER

Lecturer and PhD Candidate

Eskisehir Osmangazi University

Study Sites (2)

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