Impact of a multidisciplinary family-integrated educational model on treatment adherence, self-care behaviours and blood pressure control in elderly chinese patients with hypertension

ISRCTN	ISRCTN13397152
DOI	https://doi.org/10.1186/ISRCTN13397152
Nantong Social and People's Livelihood Science and Technology Plan-Guidance Project	MSZ2023107
Sponsor	Hainan Provincial Hospital of Traditional Chinese Medicine
Funder	Nantong Municipal Science and Technology Bureau

Submission date: 25/03/2026
Registration date: 27/03/2026
Last edited: 26/03/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration

Contact information

Dr Qianqian Liu
Public, Scientific, Principal investigator

No. 55, Ninghai Middle Road, Hai'an High-tech Zone
Nantong
226600
China

Phone	+86 18934506226
Email	liuqq_liu2505@126.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Sequential
Purpose	Supportive care
Scientific title	The impact of a multidisciplinary family-integrated educational model on treatment adherence, self-care behaviours and blood pressure control in elderly chinese patients with hypertension: a randomised controlled trial
Study objectives	To evaluate the impact of the manager–urger–self-manager–teacher (MUST) educational model on treatment adherence, self-care behaviours and blood pressure (BP) control in elderly Chinese patients with hypertension.
Ethics approval(s)	Approved 18/03/2024, Ethics Committee of Hai'an Traditional Chinese Medicine Hospital (No. 55, Ninghai Middle Road, Hai'an High-tech Zone, Nantong, 226600, China; +86 0531-81819880; haszyykjk@163.com), ref: HLYLL2024018
Health condition(s) or problem(s) studied	Treatment adherence, self-care behaviours and blood pressure control in elderly chinese patients with hypertension
Intervention	Participants will be randomised to an experimental and a control group at a 1:1 ratio using a computer-generated randomisation sequence created by an independent statistician using SAS 9.4 software (IBM, Armonk, NY, USA). The sequence will stratify by hypertension grade (Grade 1 vs Grades 2 and 3) to ensure balanced disease severity across groups. Allocation concealment will be achieved through the use of sequentially numbered, opaque, sealed envelopes containing group assignments. Control group Patients in the control group will receive routine post-discharge care, comprising structured telephone follow-ups and home visits. This included (1) psychological counselling with basic education and success stories; (2) dietary guidance (limit sodium to ≤6 g/day, reduce animal fat, increase vegetable/protein intake); (3) training on strict medication regimen compliance; (4) lifestyle advice on exercise, smoking cessation, alcohol consumption of ≤50 g/day and stress management; and (5) 20-minute phone calls (biweekly) and 60-minute home visits (monthly) for 6 months. Intervention group The experimental group underwent a 6-month multidisciplinary MUST enhancement programme. Team composition and roles will be as follows: the manager (physician) will develop personalised treatment plans and supervised collaboration; the urger (family caregiver) will monitor compliance, co-learn with the patient and reported BP fluctuations; the self-manager (patient) will collaborate to master disease knowledge and enhance self-care; and the educator (nurse) will serve as an advanced practice leader, co-directing care planning, independently monitoring clinical data, evaluating treatment efficacy and dynamically adjusting educational strategies using behavioural change theories (e.g. motivational interviewing, self-efficacy frameworks). Specifically, nurses will translate physician treatment targets (e.g., BP <140/90 mmHg) into individualized, actionable patient behaviours—such as specific timing for medication intake, sodium reduction strategies tailored to dietary preferences, and simplify home BP monitoring routines—thereby bridging the gap between clinical protocols and patients' daily lives. This study is specifically focus on the nurse-led educational components of the model, with physicians serving in a supervisory capacity to support nurse-led intervention delivery. Delivery methods will combine 10-minute bi-weekly WeChat video sessions (12 total) featuring simple language and interactive Q&As with monthly 60-minute in-person workshops (6 total) using simplified PowerPoint presentations (on patient-selected topics), peer experience sharing and practical BP measurement demonstrations.
Intervention type	Mixed
Primary outcome measure(s)	Medication adherence measured using the 8-item Morisky Medication Adherence Scale (MMAS-8) at baseline, post-intervention (6 months) Multidimensional compliance measured using the Therapeutic Adherence Scale for Hypertensive Patients (TASHP) at baseline, post-intervention (6 months) Self-care behaviours measured using the Hypertension Patients Self-Management Behavior Rating Scale (HPSMBRS) at baseline, post-intervention (6 months) Blood pressure (mmHg) measured using home monitoring with a calibrated Omron HEM-7120 devices at three daily measurements (morning, afternoon and evening). Data were recorded by family members in a standardised logbook and submitting weekly averages via WeChat screenshots to maintain blinding.
Key secondary outcome measure(s)
Completion date	26/09/2024

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	60 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	120
Total final enrolment	186
Key inclusion criteria	1. Exhibited stabilised BP (<140/90 mmHg for ≥1 month) while on a consistent antihypertensive medication regimen, defined as no changes in drug class, dosage or frequency during the 4 weeks preceding enrolment and throughout the 6-month intervention period. 2. Adequate family support was defined as having at least one literate adult family member available for ≥75% of sessions.
Key exclusion criteria	1. Secondary hypertension 2. Sefractory hypertension 3. Severe hepatic or renal dysfunction 4. Malignancy 5. Cognitive impairment (i.e. a mini-mental state examination [s mmse] score of <24) and living alone or being illiterate.
Date of first enrolment	06/01/2021
Date of final enrolment	30/12/2023

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan

Editorial Notes

25/03/2026: Study’s existence confirmed by the Ethics Committee of Hai'an Traditional Chinese Medicine Hospital, China.