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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

19. května 2026 aktualizováno: xysyy-LuJing, The Third Xiangya Hospital of Central South University

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.

Přehled studie

Postavení

Zápis na pozvánku

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

39

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Čína
    • Hunan
      • Huayuan, Hunan, Čína, 416400
        • the outpatient department of Huayuan County People's Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

(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.

Exclusion Criteria:

  1. An inability to understand and provide informed consent (e.g., people with cognitive problems or thought disorder);
  2. New York Heart Association class Ior IV heart failure;
  3. A medical condition that precludes adherence to medical recommendations (e.g., end stage cancer, active severe mental illness)
  4. Actively requesting with drawal during the research process.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: The control group
The control group received health guidance and follow-up management.
Behaviorální: 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.
Experimentální: The experimental group
The experimental group received health coaching and follow up management in addition to the usual care.
Behaviorální: 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 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
Ostatní jména:
  • Health guidance and follow-up management

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure at 6 Months
Časové okno: From enrollment to month 1, month 3 and month 6 after the intervention
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
Časové okno: 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.
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.
Časové okno: 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.
From enrollment to month 1, month 3 and month 6 after the intervention

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in BMI from baseline to six months
Časové okno: From enrollment to the end of treatment at month 1, month 3 and month 6 after the intervention
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.
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
Časové okno: From enrollment to month 1, month 3 and month 6 after the intervention
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.
From enrollment to month 1, month 3 and month 6 after the intervention

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

The Third Xiangya Hospital of Central South University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. listopadu 2025

Primární dokončení (Odhadovaný)

31. prosince 2026

Dokončení studie (Odhadovaný)

31. prosince 2026

Termíny zápisu do studia

První předloženo

19. května 2026

První předloženo, které splnilo kritéria kontroly kvality

19. května 2026

První zveřejněno (Aktuální)

26. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

26. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

19. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CSUMEC-E2025001

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Časový rámec sdílení IPD

Beginning 3 months and ending 3 years after the publication of results

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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Klinické studie na Hypertenze (HTN)

Klinické studie na Health guidance and follow-up management

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