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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 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

39

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: The control group
The control group received health guidance and follow-up management.
Comportamentale: 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.
Sperimentale: The experimental group
The experimental group received health coaching and follow up management in addition to the usual care.
Comportamentale: 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
Altri nomi:
  • Health guidance and follow-up management

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure at 6 Months
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in BMI from baseline to six months
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Third Xiangya Hospital of Central South University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 novembre 2025

Completamento primario (Stimato)

31 dicembre 2026

Completamento dello studio (Stimato)

31 dicembre 2026

Date di iscrizione allo studio

Primo inviato

19 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 maggio 2026

Primo Inserito (Effettivo)

26 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CSUMEC-E2025001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Periodo di condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Ipertensione (HTN)

Prove cliniche su Health guidance and follow-up management

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Sponsor e collaboratori

Condizioni mediche

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CROs in India

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

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