Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity

Duke Kunshan University

Status: Active, not recruiting

Conditions: Hypertension; Stroke; Multimorbidity; Type 2 Diabetes Mellitus (T2DM)

Treatments: Behavioral: Cognitive Intervention; Behavioral: Exercise Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06975501

2025DKU

Details and patient eligibility

About

This study is a cluster randomized controlled trial with a 2×2 factorial design conducted in community health centers in Kunshan, Harbin, Wuhan, Beijing 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.

Full 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), Beijing 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.

Enrollment: 444 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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444 participants in 4 patient groups

Active Control

No Intervention group

Description:

Participants in this arm will receive medication compliance education from the family doctor.

Physical Activity Only

Experimental group

Description:

Participants will receive twice-weekly aerobic and balance training sessions, with medication compliance education.

Treatment:

Behavioral: Exercise Intervention

Cognitive Training Only

Experimental group

Description:

Participants in this arm will participate in twice-weekly structured cognitive training sessions, with medication compliance education.

Treatment:

Behavioral: Cognitive Intervention

Combined Physical + Cognitive

Experimental group

Description:

Participants in this arm will receive both twice-weekly aerobic and balance training sessions and twice-weekly structured cognitive training sessions, with medication compliance education.

Treatment:

Behavioral: Exercise Intervention

Behavioral: Cognitive Intervention