Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
CEEEC
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
1 other identifier
interventional
444
1 country
1
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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2025
CompletedFirst Posted
Study publicly available on registry
May 16, 2025
CompletedStudy Start
First participant enrolled
June 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 20, 2027
January 21, 2026
May 1, 2025
1 year
April 30, 2025
January 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Intrinsic Capacity (World Health Organization Integrated Care for Older People)
Assessment of intrinsic capacity using the World Health Organization Integrated Care for Older People (WHO ICOPE) framework.
24 months
Secondary Outcomes (26)
Locomotion: SPPB (Short Physical Performance Battery)
24 months
Cognition
24 months
Psychological well-being
24 months
Vitality
24 months
Medication Adherence
24 months
- +21 more secondary outcomes
Study Arms (4)
Active Control
NO INTERVENTIONParticipants in this arm will receive medication compliance education from the family doctor.
Physical Activity Only
EXPERIMENTALParticipants will receive twice-weekly aerobic and balance training sessions, with medication compliance education.
Cognitive Training Only
EXPERIMENTALParticipants in this arm will participate in twice-weekly structured cognitive training sessions, with medication compliance education.
Combined Physical + Cognitive
EXPERIMENTALParticipants in this arm will receive both twice-weekly aerobic and balance training sessions and twice-weekly structured cognitive training sessions, with medication compliance education.
Interventions
Participants will receive twice-weekly aerobic and balance training sessions, with medication compliance education.
Participants will participate in twice-weekly structured cognitive training sessions, with medication compliance education.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Kunshan Universitylead
- Wuhan Universitycollaborator
- Harbin Medical Universitycollaborator
- Shanghai Jiao Tong University School of Medicinecollaborator
- Beijing Tiantan Hospitalcollaborator
Study Sites (1)
Duke Kunshan University
Suzhou, Jiangsu, 215316, China
Related Publications (7)
Ni Z, Atluri N, Shaw RJ, Tan J, Khan K, Merk H, Ge Y, Shrestha S, Shrestha A, Vasudevan L, Karmacharya B, Yan LL. Correction: Evaluating the Feasibility and Acceptability of a Mobile Health-Based Female Community Health Volunteer Program for Hypertension Control in Rural Nepal: Cross-Sectional Study. JMIR Mhealth Uhealth. 2020 Jun 11;8(6):e19048. doi: 10.2196/19048.
PMID: 32525811RESULTGong E, Lu H, Shao S, Tao X, Peoples N, Kohrt BA, Xiong S, Kyobutungi C, Haregu TN, Khayeka-Wandabwa C, Van Minh H, Hanh TTD, Koirala S, Gautam K, Yan LL. Feasibility assessment of invigorating grassrooTs primary healthcare for prevention and management of cardiometabolic diseases in resource-limited settings in China, Kenya, Nepal, Vietnam (the FAITH study): rationale and design. Glob Health Res Policy. 2019 Nov 12;4:33. doi: 10.1186/s41256-019-0124-0. eCollection 2019.
PMID: 31742234RESULTYan LL, Gong E, Gu W, Turner EL, Gallis JA, Zhou Y, Li Z, McCormack KE, Xu LQ, Bettger JP, Tang S, Wang Y, Oldenburg B. Effectiveness of a primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA): A cluster-randomized controlled trial. PLoS Med. 2021 Apr 28;18(4):e1003582. doi: 10.1371/journal.pmed.1003582. eCollection 2021 Apr.
PMID: 33909607RESULTTian M, Ajay VS, Dunzhu D, Hameed SS, Li X, Liu Z, Li C, Chen H, Cho K, Li R, Zhao X, Jindal D, Rawal I, Ali MK, Peterson ED, Ji J, Amarchand R, Krishnan A, Tandon N, Xu LQ, Wu Y, Prabhakaran D, Yan LL. A Cluster-Randomized, Controlled Trial of a Simplified Multifaceted Management Program for Individuals at High Cardiovascular Risk (SimCard Trial) in Rural Tibet, China, and Haryana, India. Circulation. 2015 Sep 1;132(9):815-24. doi: 10.1161/CIRCULATIONAHA.115.015373. Epub 2015 Jul 17.
PMID: 26187183RESULTYan LL, Fang W, Delong E, Neal B, Peterson ED, Huang Y, Sun N, Yao C, Li X, MacMahon S, Wu Y. Population impact of a high cardiovascular risk management program delivered by village doctors in rural China: design and rationale of a large, cluster-randomized controlled trial. BMC Public Health. 2014 Apr 11;14:345. doi: 10.1186/1471-2458-14-345.
PMID: 24721435RESULTZhu G, Malhotra R, Xiong S, Chen X, Zhang M, Wu Y, Gong E, Wang Z, Tian X, Peng W, Ostbye T, Yan LL. Community Efficacy for Non-Communicable Disease Management and Medication Adherence: The Sequential Mediating Role of Self-Efficacy and Depressive Symptoms. Patient Prefer Adherence. 2023 Dec 14;17:3421-3433. doi: 10.2147/PPA.S436419. eCollection 2023.
PMID: 38111691RESULTXiong S, Zhu G, Malhotra R, Chen X, Gong E, Wang Z, Zhang J, Peng W, Wang S, Jin X, Peoples N, Ostbye T, Tian M, Yan LL. Community efficacy for non-communicable disease management (COEN): Conceptualization and measurement. PLOS Glob Public Health. 2024 Aug 14;4(8):e0003549. doi: 10.1371/journal.pgph.0003549. eCollection 2024.
PMID: 39141640RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 30, 2025
First Posted
May 16, 2025
Study Start
June 20, 2025
Primary Completion (Estimated)
June 20, 2026
Study Completion (Estimated)
June 20, 2027
Last Updated
January 21, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
The investigators will not share the individual participant data. But de-identified data is available upon request.