China Pilot of ICOPE (Integrated Care for Older People) in Chaoyang

Sponsor
Pinetree Health Technologies (Beijing) Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT05933798
Collaborator
Peking Union Medical College Hospital (Other)
2,148
1
2
12
179.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ICOPE
  • Other: Usual Care
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
2148 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
China Pilot of ICOPE (Integrated Care for Older People) in Chaoyang District, Beijing
Actual Study Start Date :
Sep 1, 2020
Actual Primary Completion Date :
Jul 31, 2021
Actual Study Completion Date :
Aug 31, 2021

Arms and Interventions

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.

Other: ICOPE
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.

Other: Usual Care
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

Outcome Measures

Primary Outcome Measures

  1. Feasibility of implementing the ICOPE program in China [12 months]

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

Secondary Outcome Measures

  1. Independence [6 months]

    measured by the activities of daily living (ADL) 14-questionnaire scale, to assess the participant's physical function

  2. Cognition [6 months]

    measured by mini-mental status examination (MMSE) to assess the cognitive health of the participants

  3. Vitality [6 months]

    nutrition measured by mini-nutritional assessment- short form (MNA-SF) to assess the risk of malnutrition

  4. Mobility [6 months]

    measured by short physical performance battery (SPPB) to assess the risk of declining mobility

  5. Psychological health [6 months]

    measured by geriatric depression scale-five items (GDS-5) using a short set of questions to assess possible depressive symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pinetree Care Group Beijing China 100029

Sponsors and Collaborators

  • Pinetree Health Technologies (Beijing) Co., Ltd.
  • Peking Union Medical College Hospital

Investigators

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

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
Pinetree Health Technologies (Beijing) Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05933798
Other Study ID Numbers:
  • 2020-QS-001
First Posted:
Jul 6, 2023
Last Update Posted:
Jul 6, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pinetree Health Technologies (Beijing) Co., Ltd.

Study Results

No Results Posted as of Jul 6, 2023