NCT07747025

Brief Summary

Hypertension is one of the most important risk factors for cardiovascular morbidity and mortality. Effective hypertension management requires medication adherence, lifestyle modification, regular blood pressure monitoring, and self-management behaviors. Motivational interviewing is a counseling approach that may support behavior change and improve hypertension management. This study aims to evaluate the effects of nurse-led individual motivational interviewing and family-involved motivational interviewing on blood pressure control in patients with hypertension. The study will be conducted as a single-center, three-arm, parallel-group, randomized controlled trial. A total of 180 patients with hypertension will be randomly assigned to one of three groups: usual care, individual motivational interviewing, or family-involved motivational interviewing. Participants in the intervention groups will receive a 6-week nurse-led motivational interviewing program. In the family-involved motivational interviewing group, a family member who supports hypertension management will also participate in the sessions. Data will be collected at baseline, 6 weeks, and 18 weeks. The primary outcome is systolic blood pressure. Secondary outcomes include diastolic blood pressure, hypertension knowledge level, treatment adherence, and hypertension self-efficacy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
3mo left

Started Aug 2026

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Aug 2026Dec 2026

First Submitted

Initial submission to the registry

July 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 12, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 30, 2026

Last Update Submit

August 11, 2026

Conditions

Keywords

HypertensionBlood pressure controlMotivational interviewingFamily involvementNursing intervention

Outcome Measures

Primary Outcomes (1)

  • Systolic Blood Pressure

    Systolic blood pressure will be measured in mmHg using a standard blood pressure measurement procedure. Measurements will be taken after at least 5 minutes of rest using an appropriate cuff. At each assessment, at least two measurements will be taken from the same arm, and the average value will be used in the analysis. Lower systolic blood pressure values indicate better blood pressure control.

    Baseline, 6 weeks, and 18 weeks

Secondary Outcomes (4)

  • Diastolic Blood Pressure

    Baseline, 6 weeks, and 18 weeks

  • Hypertension Knowledge Level Assessed by the Hypertension Knowledge-Level Scale

    Baseline, 6 weeks, and 18 weeks

  • Treatment Adherence Assessed by the Hill-Bone Hypertension Treatment Adherence Scale

    Baseline, 6 weeks, and 18 weeks

  • Hypertension Self-Efficacy Assessed by the Hypertension Self-Efficacy Scale

    Baseline, 6 weeks, and 18 weeks

Study Arms (3)

Usual Hypertension Care With Information Brochure

ACTIVE COMPARATOR

Participants in this arm will continue to receive routine hypertension care. They will also receive a standard hypertension information brochure. No structured motivational interviewing intervention will be provided.

Behavioral: Usual Hypertension Care With Information Brochure

Nurse-Led Individual Motivational Interviewing

EXPERIMENTAL

Participants in this arm will receive a 6-week nurse-led individual motivational interviewing program in addition to routine hypertension care. The intervention will focus on hypertension awareness, medication adherence, lifestyle modification, home blood pressure monitoring, physical activity, stress management, self-efficacy, problem solving, and maintenance of motivation.

Behavioral: Individual Motivational Interviewing

Nurse-Led Family-Involved Motivational Interviewing

EXPERIMENTAL

Participants in this arm will receive the same 6-week nurse-led motivational interviewing program in addition to routine hypertension care, with the participation of a family member who supports hypertension management. The family member may support medication adherence, salt reduction, nutrition behaviors, home blood pressure monitoring, and weekly goals.

Behavioral: Family-Involved Motivational Interviewing

Interventions

The intervention is a structured 6-week nurse-led individual motivational interviewing program. Sessions will focus on hypertension awareness, individual risk factors, readiness for change, hypertension knowledge, misconceptions and complications, medication adherence, treatment barriers, salt reduction, nutrition behaviors, home blood pressure monitoring, physical activity, weight control, stress management, self-efficacy, problem solving, motivation maintenance, and individualized goal evaluation.

Nurse-Led Individual Motivational Interviewing

The intervention is a structured 6-week nurse-led motivational interviewing program delivered with the participation of a family member who supports the patient's hypertension management. The intervention content is the same as the individual motivational interviewing program. The family member will be included to support medication adherence, salt reduction, nutrition behaviors, home blood pressure monitoring, and achievement of weekly goals.

Nurse-Led Family-Involved Motivational Interviewing

Participants will continue to receive routine hypertension care and will be given a standard hypertension information brochure. No structured motivational interviewing session will be provided.

Usual Hypertension Care With Information Brochure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older
  • Diagnosed with hypertension for at least 6 months
  • Using antihypertensive medication
  • Able to read and understand Turkish
  • Conscious and able to communicate
  • Providing written informed consent
  • Having at least one family member who can support hypertension management and participate in sessions when needed

You may not qualify if:

  • Advanced cognitive impairment
  • Active psychiatric crisis
  • History of a serious cardiovascular event within the last 3 months
  • Terminal illness
  • Serious physical condition that may prevent regular participation in intervention sessions
  • Concurrent participation in another structured education program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simav Doc. Dr. Ismail Karakuyu State Hospital

Simav, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Mehta SJ, Volpp KG, Troxel AB, Teel J, Reitz CR, Purcell A, Shen H, McNelis K, Snider CK, Asch DA. Remote Blood Pressure Monitoring With Social Support for Patients With Hypertension: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2413515. doi: 10.1001/jamanetworkopen.2024.13515.

    PMID: 38829618BACKGROUND
  • Khadoura KJ, Shakibazadeh E, Mansournia MA, Aljeesh Y, Fotouhi A. Effectiveness of motivational interviewing on medication adherence among Palestinian hypertensive patients: a clustered randomized controlled trial. Eur J Cardiovasc Nurs. 2021 Jun 29;20(5):411-420. doi: 10.1093/eurjcn/zvaa015.

    PMID: 34009313BACKGROUND
  • Xu J, Gu X, Gu J, Zhao L, Li M, Hong C. Motivational interviewing intervention for the management of hypertension: a meta-analysis. Front Cardiovasc Med. 2025 Jan 20;11:1457039. doi: 10.3389/fcvm.2024.1457039. eCollection 2024.

    PMID: 39902088BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Serkan Budak, PhD / RN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and intervention providers cannot be masked due to the nature of the behavioral intervention. Outcome assessment and data analysis will be conducted with group codes masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized in a 1:1:1 ratio to usual care, individual motivational interviewing, or family-involved motivational interviewing.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 5, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 12, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study includes health-related information from patients with hypertension. De-identified aggregate results may be reported in scientific publications.

Locations