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NCT Number: NCT05933798

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pinetree Care Group

Beijing, 100029, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICOPE

Other

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

Other

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

Primary outcomes

  1. Feasibility of implementing the ICOPE program in China

    Time frame: 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 outcomes

  1. Independence

    Time frame: 6 months

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

  2. Cognition

    Time frame: 6 months

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

  3. Vitality

    Time frame: 6 months

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

  4. Mobility

    Time frame: 6 months

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

  5. 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

Sponsors and collaborators

Lead sponsor

Pinetree Health Technologies (Beijing) Co., Ltd.

Industry

Collaborators

  • Peking Union Medical College Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 6, 2023
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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