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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05933798
• Other study ID #: 2020-QS-001
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: July 2023
• Source: Pinetree Health Technologies (Beijing) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2148
• Est. completion date: August 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Healthy Aging
• Utilization, Health Care

Intervention

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
• 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

Locations

Country	Name	City	State
China	Pinetree Care Group	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Pinetree Health Technologies (Beijing) Co., Ltd.	Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Tavassoli N, de Souto Barreto P, Berbon C, Mathieu C, de Kerimel J, Lafont C, Takeda C, Carrie I, Piau A, Jouffrey T, Andrieu S, Nourhashemi F, Beard JR, Soto Martin ME, Vellas B. Implementation of the WHO integrated care for older people (ICOPE) programme in clinical practice: a prospective study. Lancet Healthy Longev. 2022 Jun;3(6):e394-e404. doi: 10.1016/S2666-7568(22)00097-6. Epub 2022 Jun 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of implementing the ICOPE program in China	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).	12 months
Secondary	Independence	measured by the activities of daily living (ADL) 14-questionnaire scale, to assess the participant's physical function	6 months
Secondary	Cognition	measured by mini-mental status examination (MMSE) to assess the cognitive health of the participants	6 months
Secondary	Vitality	nutrition measured by mini-nutritional assessment- short form (MNA-SF) to assess the risk of malnutrition	6 months
Secondary	Mobility	measured by short physical performance battery (SPPB) to assess the risk of declining mobility	6 months
Secondary	Psychological health	measured by geriatric depression scale-five items (GDS-5) using a short set of questions to assess possible depressive symptoms	6 months

External Links

•   WHO's report on findings from implementing ICOPE pilots in different countries