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

NCT07307924 | Enrolling By Invitation DMC

• 1 other identifier: E-41997688-050.99-190026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Individuals (Controls); PRIMARY HYPERTENSION PATIENT

Keywords

Primary Hypertension; Motivational Interviewing; Knowledge Level; Self-Efficacy Level; Adherence to Treatment; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

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

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

  March 2026 (3 months later)

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

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

  June 2026 (6 months after onset)

Other Outcomes (1)

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

  March 2026 (3 months later)

Study Arms (2)

Intervention Arm (Motivational interviewing)

ACTIVE COMPARATOR

A four-session intervention based on the Health Belief Model (HBM) and delivered through motivational interviewing (MI) will be provided to the intervention group. The program aims to enhance risk perception, improve treatment adherence, strengthen self-efficacy, and support lifestyle change. The first session reviews hypertension and its risks to increase perceived susceptibility and severity. The second highlights treatment benefits, medication adherence, and key lifestyle modifications. The third focuses on building self-efficacy through personalized goals and an action plan supported by tools such as blood pressure diaries. The final session reinforces motivation, evaluates progress, and introduces relapse-prevention strategies. Sessions are held biweekly, last 30-45 minutes, and are supported by structured educational materials.

Behavioral: Motivasyonel görüşme

Control Arm

NO INTERVENTION

In the control group, no educational content, counseling, or motivational interviewing was provided; participants continued with standard routine care only. Baseline, mid-intervention, and post-intervention assessments were conducted concurrently with the intervention group and included the administration of a sociodemographic information form, the Hypertension Knowledge Level Scale, the Hill-Bone Medication Adherence Scale, and the Hypertension Self-Efficacy Scale, along with standardized measurements of systolic and diastolic blood pressure. The control group served as a non-intervention comparator, allowing the natural course of patient adherence and self-management to be observed. This design ensured that any differences observed between groups could be attributed to the structured intervention rather than external influences.

Interventions

Motivasyonel görüşme BEHAVIORAL

Hipertansiyon hastalarında yaşam tarzı değişikliklerinin teşvik edilmesi, tedaviye uyumun artırılması ve öz yeterlilik düzeylerinin geliştirilmesine yönelik yapılandırılmış müdahale programları, son yıllarda literatürde önemli yer edinmiştir. Sonuç olarak, MG tabanlı müdahaleler süre, içerik ve uygulama araçları bakımından çeşitlilik gösterse de, katılımcıların tedaviye uyumunu ve yaşam tarzı değişikliklerini desteklemek üzere çok yönlü ve yapılandırılmış programlar olarak öne çıkmaktadır. Bu bağlamda, çalışmamızda SİM temelli MG programının maksimum 8 hafta süresince, iki haftada bir olacak şekilde 4 oturumdan oluşacak ve her oturumun 30 ila 45 dakika arasında değişen sürelerde gerçekleştirilmesi planlanmaktadır. Eğitim içeriği, katılımcıların bilişsel düzeyleri, sağlık algıları ve davranış değişimine yönelik motivasyon düzeyleri dikkate alınarak yapılandırılmıştır.

Intervention Arm (Motivational interviewing)

Eligibility Criteria

• Age: 25 Years - 59 Years
• Gender Eligibility Details: In the study, to ensure an equal and homogeneous distribution of participants into the intervention and control groups, the 140 individuals in the sample were allocated using stratified randomization, based on baseline prognostic factors, particularly sex. Accordingly, the intervention group was composed of 50 participants-25 women and 25 men-and the control group was structured in the same manner, with 25 women and 25 men who shared similar baseline characteristics.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Hisarardı Family Health Center affiliated with the Simav District Health Directorate

Kütahya, Kütahya/ Simav, 43500, Turkey (Türkiye)

Location

Related Links

• World Health Organization. (2023a). Global report on hypertension: The race against a silent killer. World Health Organization
• World Health Organization (2023b). Hypertension
• World Health Organization. (2023c). Primary health care

MeSH Terms

Conditions

Essential Hypertension; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases; Health Behavior; Behavior

Study Officials

• Özlem ÖRSAL, PROF

  ESKİŞEHİR OSMANGAZİ UNIVERSITY INSTITUTE OF HEALTH SCIENCES DEPARTMENT OF NURSING

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer and PhD Candidate

Model Details: A Health Belief Model-based motivational interviewing (MI) program will be implemented for participants assigned to the intervention group. Previous studies examining MI-guided nursing interventions in individuals with hypertension have predominantly adopted randomized controlled trial (RCT) designs and have emphasized individualized, patient-centered approaches. Although the duration, structure, and delivery methods of MI-based interventions vary across studies, these programs are generally designed as multifaceted and structured strategies that promote treatment adherence and support lifestyle modification. In alignment with this evidence, the MI program developed for the present study will consist of four sessions delivered over a maximum period of eight weeks. Sessions will take place biweekly and are planned to last between 30 and 45 minutes each.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 29, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Kasım 2025 - Aralık 2026

Locations

TU (1)