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
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Hunan
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Huayuan, Hunan, Kina, 416400
- the outpatient department of Huayuan County People's Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
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:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: The control group
The control group received health guidance and follow-up management.
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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.
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Eksperimentell: The experimental group
The experimental group received health coaching and follow up management in addition to the usual care.
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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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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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
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From enrollment to month 1, month 3 and month 6 after the intervention
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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
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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.
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From enrollment to month 1, month 3 and month 6 after the intervention
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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
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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.
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From enrollment to month 1, month 3 and month 6 after the intervention
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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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
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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.
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From enrollment to the end of treatment at month 1, month 3 and month 6 after the intervention
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Change in the Waist circumference from Baseline to 6 months
Tidsramme: From enrollment to month 1, month 3 and month 6 after the intervention
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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.
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From enrollment to month 1, month 3 and month 6 after the intervention
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CSUMEC-E2025001
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IPD-delingstidsramme
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
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