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HypertensionCEEECNCT06975501

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

A study testing Exercise Intervention and Cognitive Intervention in people with Hypertension and Type 2 Diabetes Mellitus (T2DM), run by Duke Kunshan University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is a cluster randomized controlled trial with a 2×2 factorial design conducted in community health centers in Kunshan, Wuhan and Shanghai, China. It aims to evaluate the independent and combined effects of exercise and cognitive interventions on intrinsic capacity and related health outcomes among stroke… Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Exercise Intervention and Cognitive Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteChina
Study dates
20 Jun 2025to 31 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

China1 site
  • Duke Kunshan University

    Suzhou, Jiangsu, 215316

Other trials in China

About this study

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

This study is a cluster randomized controlled trial with a 2×2 factorial design conducted in community health centers in Kunshan, Wuhan and Shanghai, China. 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 20 week, followed by a 12~24 month follow-up. Findings will inform integrated health management strategies for older adults with multimorbidity.

Read the detailed description

The CEEEC trial is a multicenter, 2×2 factorial cluster-randomized controlled trial evaluating the independent and combined effects of physical and cognitive enrichment among community-dwelling older adults with prior stroke and hypertension and/or type 2 diabetes in China.

The Phase I intervention is delivered over 20 weeks through community primary care teams, supported by community health volunteers and automated voice messaging. Community health stations are randomized to physical enrichment, cognitive enrichment, combined enrichment, or usual care. The primary endpoint is intrinsic capacity at 20 weeks. Secondary outcomes include cognitive and physical performance, blood pressure, physical activity, medication adherence, and health-related quality of life.

Longer-term follow-up at 12 and 24 months is planned to examine the durability of intervention effects.

Being tested
Exercise Intervention, Cognitive Intervention
Medical subject headings
Hypertension, Diabetes Mellitus, Type 2, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise InterventionBehavioural

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

  • Cognitive InterventionBehavioural

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

Study groups in NCT06975501
Study groupRoleWhat they receive
Active ControlNo interventionParticipants in this arm will receive medication compliance education from the family doctor.
Physical Activity OnlyExperimentalParticipants will receive twice-weekly aerobic and balance training sessions, with medication compliance education.
Receives: Behavioral: Exercise Intervention
Cognitive Training OnlyExperimentalParticipants in this arm will participate in twice-weekly structured cognitive training sessions, with medication compliance education.
Receives: Behavioral: Cognitive Intervention
Combined Physical + CognitiveExperimentalParticipants in this arm will receive both twice-weekly aerobic and balance training sessions and twice-weekly structured cognitive training sessions, with medication compliance education.
Receives: Behavioral: Exercise Intervention; Behavioral: Cognitive Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 20 weeks

Secondary outcomes (21)
  1. Locomotion: SPPB (Short Physical Performance Battery)

    The Short Physical Performance Battery (SPPB) is a validated, performance-based tool designed to assess lower extremity function in older adults. It consists of three components: a balance test, a gait speed test, and a chair stand test. Each component is scored on a scale from 0 to 4, with a total score ranging from 0 (worst performance) to 12 (best performance).

    Measured: 20 weeks

  2. Cognition

    Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a widely validated screening tool for mild cognitive impairment. The MoCA evaluates multiple cognitive domains, including attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.

    The MoCA score ranges from 0 to 30, with higher scores indicating better cognitive function. A score of 26 or above is generally considered within the normal range.

    Assessments will be conducted at baseline and at regular intervals across the 24-month study period to track changes over time.

    Measured: 20 weeks

  3. Psychological well-being

    Psychological well-being will be assessed using the Cornell Scale for Depression in Dementia (CSDD), a clinician-administered instrument specifically designed to assess signs of depression in individuals with cognitive impairment, including those with dementia. The CSDD incorporates information from both patient interviews and caregiver reports to increase the reliability of the assessment.

    The scale includes 19 items, each scored from 0 (absent) to 2 (severe), resulting in a total score ranging from 0 to 38. Higher scores indicate more severe depressive symptoms, reflecting poorer psychological well-being. A score of ≥12 suggests probable major depression, while scores between 8-11 indicate possible depression.

    CSDD assessments will be performed at baseline and repeated at regular intervals throughout the 24-month study period.

    Measured: 20 weeks

  4. Vitality

    Vitality will be assessed using the Mini Nutritional Assessment (MNA), a validated screening and assessment tool designed to identify older adults at risk of malnutrition or undernutrition, which are closely associated with reduced physical vitality and frailty.

    The full MNA consists of 18 items, producing a total score ranging from 0 to 30. Higher scores indicate better nutritional status, reflecting greater vitality and overall health.

    A score of 24-30 indicates normal nutritional status. Scores 17-23.5 suggest risk of malnutrition. Scores <17 indicate malnutrition. The MNA will be administered at baseline and at regular follow-ups over the 24-month study period to monitor changes in patients' nutritional status and associated vitality.

    Measured: 20 weeks

  5. Medication Adherence

    measured using the 4-item Morisky Green Levine Medication Adherence Scale (MGLS). The 4-item Morisky Green Levine Medication Adherence Scale (MGLS) is a validated self-reported questionnaire that evaluates patients' behaviors related to medication-taking. The scale consists of 4 yes/no questions, with each "yes" answer scored as 1 and each "no" as 0. The total score ranges from 0 to 4, with higher scores indicating lower adherence. A score of 0 indicates high adherence, 1-2 indicates medium adherence, and 3-4 indicates low adherence.

    Measured: 20 weeks

  6. Physical Activity (MET-min/week)

    Measurement of physical activity levels in metabolic equivalent of task (MET) minutes per week.

    Measured: 20 weeks

  7. Systolic Blood Pressure (SBP)

    Change in the systolic blood pressure.

    Measured: 20 weeks

  8. Weight

    change in weight

    Measured: 20 weeks

  9. Height

    change in height

    Measured: 20 weeks

  10. Mobility

    measured by timed-up-and-go test, a simple and quick functional mobility test that requires the participants to stand up, walk 3 meters, turn, walk back, and sit down

    Measured: 20 weeks

  11. Mental Health

    The Geriatric Depression Scale - 15 item version (GDS-15) is a self-report questionnaire designed to screen for depression in older adults. It contains 15 yes/no questions that assess mood, motivation, energy levels, and outlook on life over the past week. Scores range from 0 to 15, with higher scores indicating more severe depressive symptoms, thus reflecting a worse outcome. Each depressive answer is scored as 1 point, and the total score is the sum of these points. Commonly used cut-off points are: 0-4 (no depression), 5-8 (mild depression), 9-11 (moderate depression), and 12-15 (severe depression).

    Measured: 20 weeks

  12. Health related quality of life

    measured using EuroQol-5 Dimensions-5L (EQ5D-5L). EQ-5D-5L descriptive system comprises the following five dimensions, each describing a different aspect of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each domain, the total scores range from 0 (indicating no problem) to 5 (indicating unable to/extreme problems). In addition, the participants were required to assess how their health is today by write a number from 0 to 100 on the numbered scale. 100 means the best health the participant can image, 0 means the worst health the participant can image.

    Measured: 20 weeks

  13. Basic activities of daily living

    measured by the basic activities of daily living (ADL). The basic ADL include the following categories: Ambulating, Feeding, Dressing, Personal hygiene, Continence, and Toileting. The ADL score ranges from 0 to 12. Limitation in ADL was defined as being scored greater than 0 on ADL scales, i.e., having some or severe limitation in at least one ADL item. Higher scores mean a worse functional independence.

    Measured: 20 weeks

  14. Instrumental activities of daily living

    measured by the Lawton Instrumental Activities of Daily Living (IADL) Scale to evaluate independent living skills. The scale measures eight domains of function, including food preparation, housekeeping, laundering. The IADL score ranges from 0 to 14. Limitation in IADL was defined as being scored greater than 0 on IADL scales, i.e., having some or severe limitation in at least one IADL item. Higher scores mean a worse functional independence.

    Measured: 20 weeks

  15. Disability

    measured using modified Rankin Scale (ranged 0 (no symptom) to 5 severe disability)

    Measured: 20 weeks

  16. Locomotion: Grip strength

    Grip strength (kilogram) will be estimated through the dynamometer (YuejianTM WL-1000, Nantong, China). Trained examiners will instruct people to hold the dynamometer and squeeze the handle for a few seconds. This study both measures right and left-hand grip strength twice in each hand. The grip strength will be recorded separately. If the average grip strength of both right and left hand of is all less than the criteria (man < 30 kg, woman < 20 kg), it is defined as weak grip strength.

    Measured: 20 weeks

  17. Healthcare Utilization: Hospital Visits

    The number of hospital visits (both inpatient and outpatient) will be measured during the 24-month follow-up period. This will include the total number of hospital admissions, along with any follow-up outpatient visits associated with hospital care. Unit of Measure: Number of hospital visits

    Measured: 20 weeks

  18. Healthcare Utilization: Emergency Room Visits

    The number of emergency room visits will be assessed over the 24-month period. This includes any visits to the emergency room for acute health concerns or urgent care needs.

    Unit of Measure: Number of emergency room visits

    Measured: 20 weeks

  19. Healthcare Utilization: Outpatient Visits

    The number of outpatient visits (excluding emergency room and inpatient visits) will be measured throughout the 24-month study period. This includes visits to primary care providers, specialists, and other outpatient services.

    Unit of Measure: Number of outpatient visits

    Measured: 20 weeks

  20. Self-reported disease history (via questionnaire)

    Presence of chronic diseases reported by participants through a structured questionnaire. Unit of Measure: Count of documented diseases

    Measured: 20 weeks

  21. Disease history based on medical insurance records

    Number and type of diagnosed chronic diseases retrieved from participants' medical insurance claims data. Unit of Measure: Count of documented diseases

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2025
  2. Study start20 Jun 2025
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06975501
Sponsor's protocol ID
2025DKU
Acronym
CEEEC
Status last verified
Oct 2026
First submitted
30 Apr 2025
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The investigators will not share the individual participant data. But de-identified data is available upon request.

Publications

  • 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.

    PubMed 32525811
  • Gong 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.

    PubMed 31742234
  • Yan 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.

    PubMed 33909607
  • Tian 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.

    PubMed 26187183
  • Yan 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.

    PubMed 24721435
  • Zhu 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.

    PubMed 38111691
  • Xiong 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.

    PubMed 39141640

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Intervention and Cognitive Intervention in people with Hypertension and Type 2 Diabetes Mellitus (T2DM), run by Duke Kunshan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intrinsic Capacity (World Health Organization Integrated Care for Older People) (time frame: 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06975501, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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