Health Coaching Added to Standard Therapy for Hypertension: Blood Pressure and Quality of Life

NCT07771504 | Completed

• 1 other identifier: KET- 338/UN2.F1/ETIK/PPM.00.02
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if adding health coaching to standard therapy lowers blood pressure and increases quality of life in adults with hypertension receiving care at a primary care clinic. The main questions it aims to answer are: Does adding health coaching to standard therapy lower systolic blood pressure? Does adding health coaching to standard therapy lower diastolic blood pressure? Does adding health coaching to standard therapy increase quality of life? Researchers will compare standard therapy plus health coaching with standard therapy alone to see if adding health coaching results in greater reductions in blood pressure and greater improvements in quality of life. articipants will:

• Receive standard therapy for hypertension if assigned to the control group.
• Receive standard therapy plus four health coaching sessions over 3 months if assigned to the intervention group.
• Have their blood pressure measured before and after the study.
• Complete a quality-of-life questionnaire at the beginning and end of the study.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

• Change in Systolic Blood Pressure (SBP)

  Change in systolic blood pressure from baseline to the end of the 3-month intervention period.

  From baseline to 3 months

• Change in Diastolic Blood Pressure (DBP)

  Change in diastolic blood pressure from baseline to the end of the 3-month intervention period.

  From baseline to 3 months

• Change in Quality of Life Measured by WHOQOL-BREF

  Change in quality of life from baseline to the end of the 3-month intervention period, assessed using the Indonesian version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire consisting of 26 items. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life.

  From baseline to 3 months

Study Arms (2)

Standard Therapy

ACTIVE COMPARATOR

Participants in this arm will receive standard therapy for hypertension without health coaching.

Other: Standard Therapy

Standard Therapy Plus Health Coaching

EXPERIMENTAL

Participants in this arm will receive standard therapy for hypertension plus four health coaching sessions over 3 months.

Behavioral: Health Coaching; Other: Standard Therapy

Interventions

Health Coaching BEHAVIORAL

Four health coaching sessions delivered over 3 months in addition to standard therapy for hypertension.

Standard Therapy Plus Health Coaching

Standard Therapy OTHER

Standard therapy for hypertension according to routine clinical care and the treating physician's clinical judgment.

Standard Therapy; Standard Therapy Plus Health Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with hypertension at the study site aged \>18 years.
• Patients diagnosed with hypertension within the previous 12 months.
• Current participants of the Prolanis program at the study site.
• Willing to participate in the study and provide written informed consent.

You may not qualify if:

• Patients with hypertension who are not registered as BPJS Kesehatan participants at the study FKTP.
• Patients with hypertension who are already controlled with standard treatment.
• Patients with hypertension with comorbidities (diabetes mellitus, stroke, or heart disease).
• Patients with hypertension who smoke.
• Patients with hypertension who have obesity.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Klinik Pratama Rawat Inap annisa dua

Citeureup, West Java, 16810, Indonesia

Location

MeSH Terms

Conditions

Hypertension

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start: July 28, 2025
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)