Clinical trial NCT06975501: Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Official title: A Community-Based 2×2 Factorial Randomized Controlled Trial Evaluating a Multicomponent Physical and Cognitive Intervention for Older Adults With Stroke and Comorbid Chronic Conditions in Urban China
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Type 2 Diabetes Mellitus (T2DM)
Multimorbidity
Stroke
Lead sponsor: Duke Kunshan University
Sponsor class: OTHER
Collaborators: name: Wuhan University
name: Harbin Medical University
name: Shanghai Jiao Tong University School of Medicine
First posted: 2025-05-16
Enrollment: 444
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is a cluster randomized controlled trial with a 2×2 factorial design conducted in community health centers in Kunshan, Harbin, Wuhan and Shanghai. It aims to evaluate the independent and combined effects of exercise and cognitive interventions on intrinsic capacity and related health outcomes among stroke survivors aged 60 years and older with hypertension or type 2 diabetes mellitus. Participants will receive either exercise training, cognitive training, combined training, or usual care over 12 months, followed by a 12-month follow-up. Findings will inform integrated health management strategies for older adults with multimorbidity.

Detailed description: This study is a community-based cluster randomized controlled trial with a 2×2 factorial design, conducted in community health centers in Kunshan (Jiangsu), Wuhan (Hubei), Harbin (Heilongjiang), and Shanghai, China. A total of 480 stroke survivors aged 60 years and above with comorbid hypertension or type 2 diabetes mellitus will be recruited. Participants will be randomly assigned to one of four groups: exercise intervention only, cognitive intervention only, combined intervention, or control (usual care). The interventions, including aerobic-balance physical training and structured cognitive training, will be delivered twice weekly for 12 months, followed by a 12-month observational follow-up.

The primary outcome is intrinsic capacity (IC), assessed using the World Health Organization Integrated Care for Older People (WHO ICOPE) framework. Secondary outcomes include systolic blood pressure, quality of life (EuroQol 5-Dimension 5-Level, EQ-5D-5L), medication adherence, physical activity (Metabolic Equivalent of Task minutes per week, MET-min/week), and healthcare utilization. Data will be collected at baseline, 6, 12, and 24 months.

Intervention effects and trajectories over time will be analyzed using two-way analysis of variance (ANOVA), repeated measures ANOVA, and mixed-effects models. Implementation outcomes will be evaluated following the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The study aims to generate evidence for integrated health management strategies for older adults with stroke and multimorbidity in urban China.

Eligibility criteria: Inclusion Criteria:

* Aged ≥60 years
* The doctor diagnosed it as a stroke and it is in a stable stage (the diagnosis time is not limited)
* Patients with concurrent hypertension and/or diabetes may also have other diseases at the same time
* Be able to participate in a community intervention lasting for six months
* Be informed and agree to participate in the research

Exclusion Criteria:

* With the aid of a walking aid (not a wheelchair), it is also impossible to walk independently to the community service center.
* Lack basic communication skills and do not recognize Arabic numerals
* Suffering from life-threatening diseases, with a survival expectation of less than 6 months, etc.

Primary outcomes:
measure: Intrinsic Capacity (World Health Organization Integrated Care for Older People)
timeFrame: 24 months
Secondary outcomes:
measure: Locomotion: SPPB (Short Physical Performance Battery)
timeFrame: 24 months
measure: Cognition
timeFrame: 24 months
measure: Psychological well-being
timeFrame: 24 months
measure: Vitality
timeFrame: 24 months
measure: Medication Adherence
timeFrame: 24 months
measure: Physical Activity (MET-min/week)
timeFrame: 24 months
measure: Systolic Blood Pressure (SBP)
timeFrame: 24 months
measure: Weight
timeFrame: 24 months
measure: Height
timeFrame: 24 months
measure: Neck circumference
timeFrame: 24 months
measure: Waist circumference
timeFrame: 24 months
measure: Mobility
timeFrame: 24 months
measure: Mental Health
timeFrame: 24 months
measure: Health related quality of life
timeFrame: 24 months
measure: Lifestyle risk factors
timeFrame: 24 months
measure: Basic activities of daily living
timeFrame: 24 months
measure: Instrumental activities of daily living
timeFrame: 24 months
measure: Disability
timeFrame: 24 months
measure: Multimorbidity
timeFrame: 24 months
measure: Locomotion: Grip strength
timeFrame: 24 months
measure: Continuation of medication taking
timeFrame: 24 months
measure: Healthcare Utilization: Hospital Visits
timeFrame: 24 months
measure: Healthcare Utilization: Emergency Room Visits
timeFrame: 24 months
measure: Healthcare Utilization: Outpatient Visits
timeFrame: 24 months
measure: Self-reported disease history (via questionnaire)
timeFrame: 24 months
measure: Disease history based on medical insurance records
timeFrame: 24 months
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Duke Kunshan University
state: Jiangsu
Study officials:
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