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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. maj 2026 opdateret af: 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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

39

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: The control group
The control group received health guidance and follow-up management.
Adfærdsmæssigt: 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.
Eksperimentel: The experimental group
The experimental group received health coaching and follow up management in addition to the usual care.
Adfærdsmæssigt: 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
Andre navne:
  • Health guidance and follow-up management

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure at 6 Months
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in BMI from baseline to six months
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Third Xiangya Hospital of Central South University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2025

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

19. maj 2026

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CSUMEC-E2025001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-delingstidsramme

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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Kliniske forsøg med Hypertension (HTN)

Kliniske forsøg med Health guidance and follow-up management

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