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

Обзор

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.

Вмешательства

• Поведенческое Nurse-led Health Coaching
  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 ch
• Поведенческое Health guidance and follow-up management
  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.

Первичные конечные точки

• Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure at 6 Months [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: From enrollment to month 1, month 3 and month 6 after the intervention]

Вторичные конечные точки (2)

• Changes in BMI from baseline to six months [Срок оценки: 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 [Срок оценки: From enrollment to month 1, month 3 and month 6 after the intervention]

Критерии участия

Критерии включения

(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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Организация здравоохранения

Центры проведения

Китай · 1 центр

• the outpatient department of Huayuan County People's Hospital — Huayuan

Идентификаторы

NCT: NCT07606768 · CSUMEC-E2025001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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