Clinical trial NCT05933798: China Pilot of ICOPE (Integrated Care for Older People) in Chaoyang
Official title: China Pilot of ICOPE (Integrated Care for Older People) in Chaoyang District, Beijing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Healthy Aging
Utilization, Health Care
Keywords: integrated care
primary care
ICOPE
decade of healthy ageing
Lead sponsor: Pinetree Health Technologies (Beijing) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking Union Medical College Hospital
First posted: 2023-07-06
Enrollment: 2148
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of implementing the ICOPE program in China
timeFrame: 12 months
Secondary outcomes:
measure: Independence
timeFrame: 6 months
measure: Cognition
timeFrame: 6 months
measure: Vitality
timeFrame: 6 months
measure: Mobility
timeFrame: 6 months
measure: Psychological health
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Pinetree Care Group
Study officials:
affiliation: Pinetree Care Group
name: Ninie Wang, MBA DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.