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:

  1. Whether it is feasible to implement the ICOPE approach in China;
  2. 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

Completed

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:

  1. Whether it is feasible to implement the ICOPE approach in China;
  2. 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:

  1. Independence is measured by the activities of daily living (ADL) 14-questionnaire scale.
  2. Cognition is measured by mini-mental status examination (MMSE).
  3. Vitality or nutrition is measured by by mini-nutritional assessment- short form (MNA-SF) to assess the risk of malnutrition.
  4. Mobility is measured by short physical performance battery (SPPB).
  5. Psychological health is measured by geriatric depression scale-five items (GDS-5).

Study Type

Interventional

Enrollment (Actual)

2148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beijing, China, 100029
        • Pinetree Care Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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
Active Comparator: Control Group
Pariticpants who continued receiving usual care during the study period.
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

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
  1. Sample size (to successfully recruit over 2,000 participants, 500 of whom were to be categorized in the intervention group)
  2. Capacity building (at least 200 primary care providers to be fully trained and deployed in the pilot program)
  3. Acceptance (reach more than 90% satisfaction with the pilot by both participants and providers).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Independence
Time Frame: 6 months
measured by the activities of daily living (ADL) 14-questionnaire scale, to assess the participant's physical function
6 months
Cognition
Time Frame: 6 months
measured by mini-mental status examination (MMSE) to assess the cognitive health of the participants
6 months
Vitality
Time Frame: 6 months
nutrition measured by mini-nutritional assessment- short form (MNA-SF) to assess the risk of malnutrition
6 months
Mobility
Time Frame: 6 months
measured by short physical performance battery (SPPB) to assess the risk of declining mobility
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ninie Wang, MBA DrPH, Pinetree Care Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

July 2, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 2, 2023

Last Verified

July 1, 2023

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)?

NO

IPD Plan Description

Access to de-identified data of the China ICOPE Pilot (2020-2021) by other researchers is subject to the approval of an independent review committee and after signing a data access and a data use agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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