Hypertension (HTN)NCT07606768
The Effect of Nurse-led Health Coaching on Blood Pressure Control and Disease Self-management Among Patients With Hypertension in Huayuan County, Western Hunan, China: a Randomized Controlled Trial
A study testing Nurse-led Health Coaching and Health guidance and follow-up management in people with Hypertension (HTN), run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Background: Effective self-management of hypertension (HTN) is the key to adequate blood pressure control. The self-management education for patients with HTN has not been widely provided in Huayuan County, Western Hunan, China. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension (HTN)
- What is being tested?
- Nurse-led Health Coaching and Health guidance and follow-up management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1)Age≥18 years old, age ≤ 85 years and free of language communication barriers (2）Diagnosis with Stage 2 HTN (systolic blood pressure >140 and or diastolic>90) ; (3)Taking at least 1 anti-hypertensive medication；Taking anti-hypertensive drugs for ≥ 2 weeks; (4) having a mobile phone or landline phone.
Who cannot join
- An inability to understand and provide informed consent (e.g., people with cognitive problems or thought disorder);
- New York Heart Association class Ior IV heart failure;
- A medical condition that precludes adherence to medical recommendations (e.g., end stage cancer, active severe mental illness)
- Actively requesting with drawal during the research process.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the outpatient department of Huayuan County People's Hospital
Huayuan, Hunan, 416400
About this study
Background: Effective self-management of hypertension (HTN) is the key to adequate blood pressure control. The self-management education for patients with HTN has not been widely provided in Huayuan County, Western Hunan, China. Health coaching is a goal-oriented, client-centered partnership focused on a process of client enlightenment and empowerment which has shown to be effective in improving self-management behaviors. However, little is known whether such intervention is effective for adults with newly diagnosed with HTN in Huayuan County, Western Hunan, China.
The aims of the study are to examine the effect of nurse-led health coaching on controlling BP and improving self-management among patients with HTN in Huayuan County Western Hunan, China.
Read more
We will conduct a single-center six-month, two-arm randomized controlled trial (RCT) at the outpatient department of Huayuan County People's Hospital. It will recruit 78 participants with HTN. The control group received health guidance and follow-up management, the experimental group received health coaching and follow up management in addition to the usual care.
The intervention content was divided into three parts. The initial stage, the core stage and the maintenance stage, respectively, which included ten steps. After obtaining participants' participant informed consent, baseline data were collected, at month 1, month 3 and month 6 after the intervention, the participants were asked to fill in the questionnaires again when they came to the hospital for follow-up. The primary outcomes were the difference in changes of blood pressure, medication literacy and self-management scores. The secondary outcomes included body mass index (BMI), waist circumference (WC).Once the intervention is confirmed to be effective, we will implement the health coaching in the control group.
- Conditions
- Hypertension (HTN)
- Being tested
- Nurse-led Health Coaching, Health guidance and follow-up management
- Keywords
- Hypertension, Self-management, health coaching
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led Health CoachingBehavioural
Also called Health guidance and follow-up management
The intervention content was divided into three parts, the initial stage, the core stage and the maintenance stage, respectively, which included ten steps. The initial step in each health coaching session was to set the agenda for these session with the participant. This was achieved by asking the participant "What would be helpful to talk about today?" Once the participant identified a key issue for discussion, health coaches utilized their skills in Ml by assessing current stage of behavior change in relation to the issue and exploring the motivation and commitment for change. If a participant displayed a need and adequate commitment to change, the health coaches worked with the participant to establish a goal for behavior change, which included where, when and how the behavior change would be performed. This intervention consisted of one-on-one health coaching at the baseline visit, then participants received a face-to-face
Health guidance and follow-up managementBehavioural
Participants in control group received usual care and regular follow-up after discharge, which included (l) nurse sat the cardiology unit provided education focusing on hypertension knowledge on the lst and 2nd day at admission, diet on Day 3, exercise and triggers for elevated BP on Day 4, and medication management on the discharge day: and (2) telephone follow-ups in 15 days after discharge, then monthly for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| The control group | Active comparator | The control group received health guidance and follow-up management. Receives: Behavioral: Health guidance and follow-up management |
| The experimental group | Experimental | The experimental group received health coaching and follow up management in addition to the usual care. Receives: Behavioral: Nurse-led Health Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure at 6 Months
Measured: From enrollment to month 1, month 3 and month 6 after the intervention
Change in the Mean Self-management Scale for patients with Hypertension from Baseline to 6 Months
Self-management Scale for patients with Hypertension is a five-point Likert scale, to evaluate self-management behavior of hypertensive patients that has 4 dimensions diet and exercise management, monitoring of symptoms and signs related to blood pressure and medication management, lifestyle management, and risk factors management. The higher score represents the better self-management. The Cronbach's alpha is 0.85, the content validity is 0.98.
Measured: From enrollment to month 1, month 3 and month 6 after the intervention
Change in the Mean Medication Literacy Scale for Hypertensive Patients from Baseline to 6 Months.
The revised version of Chinese Medication Literacy Scale for Hypertensive Patients is a 18 item, five-point Likert scale that has four subscales for knowledge, attitude, skill, and behavior scale for assessing medication literacy of hypertensive patients. There were 4 items in the dimension of medication knowledge, which are multiple-choice questions. Choosing 1 option correctly earns 1 point. There are 3 items in the dimension of medication attitude and 4 items in the dimension of medication behavior, all of which were scored 0-4 points using Likert's 5-level rating. The items A1 to A3 in the dimension of medication attitude were scored in reverse. There are 7 items in the medication skill dimension, a correct answer for one item is scored 1, and a wrong or unknown answer is scored 0. The score is calculated to create an overall medication literacy score ranging from 0 to 37. The Cronbach's αis 0.802, and the split half reliability coefficient is 0.709.
Measured: From enrollment to month 1, month 3 and month 6 after the intervention
Secondary outcomes (2)
Changes in BMI from baseline to six months
BMI was calculated as weight (kg) divided by height squared (m2).Weight and height were measured by an ultrasonic height measuring instrument (RCS-200, Jiangsu Suhong Medical Instrument Co.LTD).The capacity of weight of the instrument is 200kg and height range to measured is80-220 cm. Participants with BMI < 24 kg/m2 were regarded as being of normal weight, ≥25 kg/m2 but <28 kg/m2 as overweight, and ≥28 kg/m2 as obese per Chinese guidelines.
Measured: From enrollment to the end of treatment at month 1, month 3 and month 6 after the intervention
Change in the Waist circumference from Baseline to 6 months
Waist circumference (cm) was measured at the level midway between the lowest rib margin and the iliac crest. Waist circumference beyond 85cm for men and beyond 80 cm for women was used as the cut-off points for central obesity.
Measured: From enrollment to month 1, month 3 and month 6 after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Nov 2025
- 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.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xysyy-LuJing, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606768
- Sponsor's protocol ID
- CSUMEC-E2025001
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nurse-led Health Coaching on Blood Pressure Control and Disease Self-management Among Patients With Hypertension in Huayuan County, Western Hunan, China: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07606768
- Acronym / sponsor ID
- CSUMEC-E2025001
- Conditions
- Hypertension (HTN)
- Keywords
- Hypertension, Self-management, health coaching
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 May 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.
Background: Effective self-management of hypertension (HTN) is the key to adequate blood pressure control. The self-management education for patients with HTN has not been widely provided in Huayuan County, Western Hunan, China. Health coaching is a goal-oriented, client-centered partnership focused on a process of client enlightenment and empowerment which has shown to be effective in improving self-management behaviors. However, little is known whether such intervention is effective for adults with newly diagnosed with HTN in Huayuan County, Western Hunan, China.
The aims of the study are to examine the effect of nurse-led health coaching on controlling BP and improving self-management among patients with HTN in Huayuan County Western Hunan, China.
We will conduct a single-center six-month, two-arm randomized controlled trial (RCT) at the outpatient department of Huayuan County People's Hospital. It will recruit 78 participants with HTN. The control group received health guidance and follow-up management, the experimental group received health coaching and follow up management in addition to the usual care.
The intervention content was divided into three parts. The initial stage, the core stage and the maintenance stage, respectively, which included ten steps. After obtaining participants' participant informed consent, baseline data were collected, at month 1, month 3 and month 6 after the intervention, the participants were asked to fill in the questionnaires again when they came to the hospital for follow-up. The primary outcomes were the difference in changes of blood pressure, medication literacy and self-management scores. The secondary outcomes included body mass index (BMI), waist circumference (WC).Once the intervention is confirmed to be effective, we will implement the health coaching in the control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | Active comparator | Behavioral: Health guidance and follow-up managementThe control group received health guidance and follow-up management. |
| The experimental group | Experimental | Behavioral: Nurse-led Health CoachingThe experimental group received health coaching and follow up management in addition to the usual care. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1)Age≥18 years old, age ≤ 85 years and free of language communication barriers (2）Diagnosis with Stage 2 HTN (systolic blood pressure >140 and or diastolic>90) ; (3)Taking at least 1 anti-hypertensive medication；Taking anti-hypertensive drugs for ≥ 2 weeks; (4) having a mobile phone or landline phone.
Key exclusion criteria (4 listed)
- An inability to understand and provide informed consent (e.g., people with cognitive problems or thought disorder);
- New York Heart Association class Ior IV heart failure;
- A medical condition that precludes adherence to medical recommendations (e.g., end stage cancer, active severe mental illness)
- Actively requesting with drawal during the research process.
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 |
|---|---|---|
| Nurse-led Health CoachingAlso: Health guidance and follow-up managementThe intervention content was divided into three parts, the initial stage, the core stage and the maintenance stage, respectively, which included ten steps. The initial step in each health coaching session was to set the agenda for these session with the participant. This was achieved by asking the participant "What would be helpful to talk about today?" Once the participant identified a key issue for discussion, health coaches utilized their skills in Ml by assessing current stage of behavior change in relation to the issue and exploring the motivation and commitment for change. If a participant displayed a need and adequate commitment to change, the health coaches worked with the participant to establish a goal for behavior change, which included where, when and how the behavior change would be performed. This intervention consisted of one-on-one health coaching at the baseline visit, then participants received a face-to-face | Behavioural | The experimental group |
| Health guidance and follow-up managementParticipants in control group received usual care and regular follow-up after discharge, which included (l) nurse sat the cardiology unit provided education focusing on hypertension knowledge on the lst and 2nd day at admission, diet on Day 3, exercise and triggers for elevated BP on Day 4, and medication management on the discharge day: and (2) telephone follow-ups in 15 days after discharge, then monthly for 6 months. | Behavioural | The control group |
Primary outcome
Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure at 6 Months
Time frame: From enrollment to month 1, month 3 and month 6 after the intervention
Change in the Mean Self-management Scale for patients with Hypertension from Baseline to 6 Months
Time frame: From enrollment to month 1, month 3 and month 6 after the intervention
Self-management Scale for patients with Hypertension is a five-point Likert scale, to evaluate self-management behavior of hypertensive patients that has 4 dimensions diet and exercise management, monitoring of symptoms and signs related to blood pressure and medication management, lifestyle management, and risk factors management. The higher score represents the better self-management. The Cronbach's alpha is 0.85, the content validity is 0.98.
Change in the Mean Medication Literacy Scale for Hypertensive Patients from Baseline to 6 Months.
Time frame: From enrollment to month 1, month 3 and month 6 after the intervention
The revised version of Chinese Medication Literacy Scale for Hypertensive Patients is a 18 item, five-point Likert scale that has four subscales for knowledge, attitude, skill, and behavior scale for assessing medication literacy of hypertensive patients. There were 4 items in the dimension of medication knowledge, which are multiple-choice questions. Choosing 1 option correctly earns 1 point. There are 3 items in the dimension of medication attitude and 4 items in the dimension of medication behavior, all of which were scored 0-4 points using Likert's 5-level rating. The items A1 to A3 in the dimension of medication attitude were scored in reverse. There are 7 items in the medication skill dimension, a correct answer for one item is scored 1, and a wrong or unknown answer is scored 0. The score is calculated to create an overall medication literacy score ranging from 0 to 37. The Cronbach's αis 0.802, and the split half reliability coefficient is 0.709.
2 secondary outcomes
Changes in BMI from baseline to six months
Time frame: From enrollment to the end of treatment at month 1, month 3 and month 6 after the intervention
Change in the Waist circumference from Baseline to 6 months
Time frame: From enrollment to month 1, month 3 and month 6 after the intervention
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 26 May 2026.
- Individual participant dataSharing planned: Yes
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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.
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 Nurse-led Health Coaching and Health guidance and follow-up management in people with Hypertension (HTN), run by The Third Xiangya Hospital of Central South University at 1 site in China.
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 1 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 26 May 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 China. 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?
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 from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure at 6 Months (time frame: From enrollment to month 1, month 3 and month 6 after the intervention). 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 26 May 2026.