HypertensionNCT07771504
Health Coaching Added to Standard Therapy for Hypertension: Blood Pressure and Quality of Life
A study testing Health Coaching and Standard Therapy in people with Hypertension, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Health Coaching and Standard Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteIndonesia
- Study dates
- 28 Jul 2025to 12 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Klinik Pratama Rawat Inap annisa dua
Citeureup, West Java, 16810
About this study
Official title: The Effect of Health Coaching on Hypertension Management on Blood Pressure and Quality of Life of Patients in Primary Health Care Facilities
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?
Read more
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
- Being tested
- Health Coaching, Standard Therapy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
Four health coaching sessions delivered over 3 months in addition to standard therapy for hypertension.
Standard TherapyOther
Standard therapy for hypertension according to routine clinical care and the treating physician's clinical judgment.
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy | Active comparator | Participants in this arm will receive standard therapy for hypertension without health coaching. Receives: 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. Receives: Behavioral: Health Coaching; Other: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure (SBP)
Change in systolic blood pressure from baseline to the end of the 3-month intervention period.
Measured: 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.
Measured: 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.
Measured: From baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start28 Jul 2025
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agus Sugiharto, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771504
- Sponsor's protocol ID
- KET- 338/UN2.F1/ETIK/PPM.00.02
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Coaching on Hypertension Management on Blood Pressure and Quality of Life of Patients in Primary Health Care Facilities
- ClinicalTrials.gov ID
- NCT07771504
- Acronym / sponsor ID
- KET- 338/UN2.F1/ETIK/PPM.00.02
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | Active comparator | Other: Standard TherapyParticipants in this arm will receive standard therapy for hypertension without health coaching. |
| Standard Therapy Plus Health Coaching | Experimental | Behavioral: Health Coaching, Other: Standard TherapyParticipants in this arm will receive standard therapy for hypertension plus four health coaching sessions over 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health CoachingFour health coaching sessions delivered over 3 months in addition to standard therapy for hypertension. | Behavioural | Standard Therapy Plus Health Coaching |
| Standard TherapyStandard therapy for hypertension according to routine clinical care and the treating physician's clinical judgment. | Other | Standard Therapy, Standard Therapy Plus Health Coaching |
Primary outcome
Change in Systolic Blood Pressure (SBP)
Time frame: From baseline to 3 months
Change in systolic blood pressure from baseline to the end of the 3-month intervention period.
Change in Diastolic Blood Pressure (DBP)
Time frame: From baseline to 3 months
Change in diastolic blood pressure from baseline to the end of the 3-month intervention period.
Change in Quality of Life Measured by WHOQOL-BREF
Time frame: From baseline to 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching and Standard Therapy in people with Hypertension, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure (SBP) (time frame: From baseline to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.