- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05933798
China Pilot of ICOPE (Integrated Care for Older People) in Chaoyang
China Pilot of ICOPE (Integrated Care for Older People) in Chaoyang District, Beijing
The goal of this pilot study is to examine predefined parameters (sample size, capacity building, acceptance by community-dwelling older people (participants) and care providers) to evaluate the feasibility of implementing World Health Organization's ICOPE (integrated care for older people) approach in China. The main questions it aims to answer are:
- Whether it is feasible to implement the ICOPE approach in China;
- Whether the integrated care approach would make any difference in health outcomes and resource utilization.
Participating older adults receiving integrated care (Intervention Group) are compared to those receiving usual care (Control Group) in order to answer the two questions above.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of this pilot study is to evaluate the feasibility of implementing World Health Organization's ICOPE (integrated care for older people) approach in China. The main questions it aims to answer are:
- Whether it is feasible to implement the ICOPE approach in China;
- Whether the integrated care approach would make any difference in health outcomes and resource utilization.
For the first question, predefined parameters such as sample size, capacity building, acceptance by community-dwelling older people (participants) and care providers were examined.
Based on literature review and also as evidenced in the background study of the ICOPE guideline development process, a key hypothesis is that implementing integrated care management programs can improve health outcomes while containing costs.
According to the pilot study design, a total of 2000 community-dwelling older persons aged 60 and above at-risk of functional loss in Chaoyang District of Beijing are recruited and randomly assigned to the intervention group (n=500) and control group (n=1500).
Chaoyang is the most populated district in Beijing, with subdistricts that are urban, suburban and rural, well representing the city of Beijing. To identify potential participants who are at risk of functional loss, the pilot used ICOPE screening tools in the recruitment process, to screen for any losses in mobility, cognition, vitality, psychological health, vision and hearing.
Screening tools used are:
- Independence is measured by the activities of daily living (ADL) 14-questionnaire scale.
- Cognition is measured by mini-mental status examination (MMSE).
- Vitality or nutrition is measured by by mini-nutritional assessment- short form (MNA-SF) to assess the risk of malnutrition.
- Mobility is measured by short physical performance battery (SPPB).
- Psychological health is measured by geriatric depression scale-five items (GDS-5).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Beijing, China, 100029
- Pinetree Care Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Screened as positive for intrinsic capacity declines
- Decline in intrinsic capacity confirmed by in-depth assessment in any of the domains described as: MMSE < 27 (for cognition), SPPB ≤ 9 (for locomotion), MNA-SF <12 (for vitality we used nutrition as a proxy), GDS-5 ≥ 2 (for psychology we used depression as a proxy) or any vision impairment
- Signed form of consent and willingly participate in the pilot study
Exclusion Criteria:
- Negative results in their intrinsic capacity decline screening
- Severe hearing problems as the study was conducted during COVID-19 pandemics period and relied on telecare or remote sessions of intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
Participants who were actively followed up during the study period with a personalized integrated care plan developed following the ICOPE screening and assessment, identified as "at-risk" for loss in intrinsic capacity.
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The ICOPE approach with locally adapted care pathways was implemented by trained integrated care managers (ICMs) advised by multi-disciplinary teams, delivered in primary care settings
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Active Comparator: Control Group
Pariticpants who continued receiving usual care during the study period.
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Participants in the Control Group would have their care plan after assessment and seek health and care services as usual without additional advice or support on implementing the care plan
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of implementing the ICOPE program in China
Time Frame: 12 months
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Independence
Time Frame: 6 months
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measured by the activities of daily living (ADL) 14-questionnaire scale, to assess the participant's physical function
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6 months
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Cognition
Time Frame: 6 months
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measured by mini-mental status examination (MMSE) to assess the cognitive health of the participants
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6 months
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Vitality
Time Frame: 6 months
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nutrition measured by mini-nutritional assessment- short form (MNA-SF) to assess the risk of malnutrition
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6 months
|
Mobility
Time Frame: 6 months
|
measured by short physical performance battery (SPPB) to assess the risk of declining mobility
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6 months
|
Psychological health
Time Frame: 6 months
|
measured by geriatric depression scale-five items (GDS-5) using a short set of questions to assess possible depressive symptoms
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6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ninie Wang, MBA DrPH, Pinetree Care Group
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020-QS-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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