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

NCT07606768 | Enrolling By Invitation

• 1 other identifier: CSUMEC-E2025001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypertension (HTN)

Keywords

Hypertension; Self-management; health coaching

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure at 6 Months

  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.

  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.

  From enrollment to month 1, month 3 and month 6 after the intervention

Secondary Outcomes (2)

• Changes in BMI from baseline to six months

  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

  From enrollment to month 1, month 3 and month 6 after the intervention

Study Arms (2)

The control group

ACTIVE COMPARATOR

The control group received health guidance and follow-up management.

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.

Behavioral: Nurse-led Health Coaching

Interventions

Nurse-led Health Coaching BEHAVIORAL

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

Also known as: Health guidance and follow-up management

The experimental group

Health guidance and follow-up management BEHAVIORAL

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.

The control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

the outpatient department of Huayuan County People's Hospital

Huayuan, Hunan, 416400, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse-in-Charge

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years after the publication of results

Locations

CN (1)