HypertensionNCT07747025
Nurse-Led Motivational Interviewing for Blood Pressure Control
A study testing Individual Motivational Interviewing, Family-Involved Motivational Interviewing and Usual Hypertension Care With Information Brochure in people with Hypertension, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Individual Motivational Interviewing, Family-Involved Motivational Interviewing and Usual Hypertension Care With Information Brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Simav Doc. Dr. Ismail Karakuyu State Hospital
Simav
About this study
Official title: The Effect of Nurse-Led Individual and Family-Involved Motivational Interviewing on Blood Pressure Control in Patients With Hypertension: A Three-Arm Randomized Controlled Trial
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.
Read the detailed description
The study intervention is a non-invasive, education- and counseling-based behavioral nursing intervention. Participants in the control group will continue to receive routine hypertension care and will be given a standard hypertension information brochure. Participants in the individual motivational interviewing group will receive nurse-led individual motivational interviewing sessions. Participants in the family-involved motivational interviewing group will receive the same intervention, with the participation of a family member who supports the patient's hypertension management.
The intervention content includes 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. Intervention fidelity will be monitored using a session checklist.
- Conditions
- Hypertension
- Being tested
- Individual Motivational Interviewing, Family-Involved Motivational Interviewing, Usual Hypertension Care With Information Brochure
- Keywords
- Hypertension, Blood pressure control, Motivational interviewing, Family involvement, Nursing intervention
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Motivational InterviewingBehavioural
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.
Family-Involved Motivational InterviewingBehavioural
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.
Usual Hypertension Care With Information BrochureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Family-Involved Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, and 18 weeks
Secondary outcomes (4)
Diastolic Blood Pressure
Diastolic 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 diastolic blood pressure values indicate better blood pressure control.
Measured: Baseline, 6 weeks, and 18 weeks
Hypertension Knowledge Level Assessed by the Hypertension Knowledge-Level Scale
Hypertension knowledge level will be assessed using the Hypertension Knowledge-Level Scale. The scale includes 22 items. Total scores range from 0 to 22. Higher scores indicate a higher level of hypertension-related knowledge.
Measured: Baseline, 6 weeks, and 18 weeks
Treatment Adherence Assessed by the Hill-Bone Hypertension Treatment Adherence Scale
Treatment adherence will be assessed using the Hill-Bone Hypertension Treatment Adherence Scale. The scale includes 12 items. Total scores range from 12 to 48. Higher scores indicate poorer adherence to hypertension treatment, while lower scores indicate better treatment adherence.
Measured: Baseline, 6 weeks, and 18 weeks
Hypertension Self-Efficacy Assessed by the Hypertension Self-Efficacy Scale
Hypertension self-efficacy will be assessed using the Hypertension Self-Efficacy Scale. The scale includes 20 items. Total scores range from 20 to 80. Higher scores indicate higher hypertension self-efficacy.
Measured: Baseline, 6 weeks, and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Aug 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe 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
- Model description
- Participants will be randomized in a 1:1:1 ratio to usual care, individual motivational interviewing, or family-involved motivational interviewing.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747025
- Sponsor's protocol ID
- KSBU-HTN-RCT-2026-01
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38829618Khadoura 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.
PubMed 34009313Xu 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.
PubMed 39902088
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nurse-Led Individual and Family-Involved Motivational Interviewing on Blood Pressure Control in Patients With Hypertension: A Three-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07747025
- Acronym / sponsor ID
- KSBU-HTN-RCT-2026-01
- Conditions
- Hypertension
- Keywords
- Hypertension, Blood pressure control, Motivational interviewing, Family involvement, Nursing intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 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.
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.
Detailed description
The study intervention is a non-invasive, education- and counseling-based behavioral nursing intervention. Participants in the control group will continue to receive routine hypertension care and will be given a standard hypertension information brochure. Participants in the individual motivational interviewing group will receive nurse-led individual motivational interviewing sessions. Participants in the family-involved motivational interviewing group will receive the same intervention, with the participation of a family member who supports the patient's hypertension management.
The intervention content includes 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. Intervention fidelity will be monitored using a session checklist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized in a 1:1:1 ratio to usual care, individual motivational interviewing, or family-involved motivational interviewing.
| Arm | Type | Receives |
|---|---|---|
| Usual Hypertension Care With Information Brochure | Active comparator | Behavioral: Usual Hypertension Care With Information BrochureParticipants 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. |
| Nurse-Led Individual Motivational Interviewing | Experimental | Behavioral: Individual Motivational InterviewingParticipants 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. |
| Nurse-Led Family-Involved Motivational Interviewing | Experimental | Behavioral: Family-Involved Motivational InterviewingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Individual Motivational InterviewingThe 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. | Behavioural | Nurse-Led Individual Motivational Interviewing |
| Family-Involved Motivational InterviewingThe 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. | Behavioural | Nurse-Led Family-Involved Motivational Interviewing |
| Usual Hypertension Care With Information BrochureParticipants will continue to receive routine hypertension care and will be given a standard hypertension information brochure. No structured motivational interviewing session will be provided. | Behavioural | Usual Hypertension Care With Information Brochure |
Primary outcome
Systolic Blood Pressure
Time frame: Baseline, 6 weeks, and 18 weeks
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.
4 secondary outcomes
Diastolic Blood Pressure
Time frame: Baseline, 6 weeks, and 18 weeks
Hypertension Knowledge Level Assessed by the Hypertension Knowledge-Level Scale
Time frame: Baseline, 6 weeks, and 18 weeks
Treatment Adherence Assessed by the Hill-Bone Hypertension Treatment Adherence Scale
Time frame: Baseline, 6 weeks, and 18 weeks
Hypertension Self-Efficacy Assessed by the Hypertension Self-Efficacy Scale
Time frame: Baseline, 6 weeks, and 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 38829618Mehta 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.
- Background: PubMed 34009313Khadoura 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.
- Background: PubMed 39902088Xu 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.
- Individual participant dataSharing planned: No. 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Motivational Interviewing, Family-Involved Motivational Interviewing and Usual Hypertension Care With Information Brochure in people with Hypertension, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 12 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serkan Budak, PhD / RN (+905385430616, serkan.budak@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: Baseline, 6 weeks, and 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07747025, which also lists 3 linked publications.
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 12 Aug 2026.