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AgingNCT05933798

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

A study testing ICOPE in people with Aging and Healthy Aging, run by Pinetree Health Technologies (Beijing) Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Aging, Healthy Aging, Utilization, Health Care
What is being tested?
ICOPE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,148 participants
Where
1 siteChina
Study dates
1 Sep 2020to 31 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Pinetree Care Group

    Beijing, 100029

Other trials in China

About this study

Official title: 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.

Read the 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).
Being tested
ICOPE, Usual Care
Keywords
integrated care, primary care, ICOPE, decade of healthy ageing
Medical subject headings
Patient Acceptance of Health Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICOPEOther

    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 CareOther

    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

Study groups in NCT05933798
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants 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.
Receives: Other: ICOPE
Control GroupActive comparatorPariticpants who continued receiving usual care during the study period.
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of implementing the ICOPE program in China

    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).

    Measured: 12 months

Secondary outcomes (5)

  1. Independence

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

    Measured: 6 months

  2. Cognition

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

    Measured: 6 months

  3. Vitality

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

    Measured: 6 months

  4. Mobility

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

    Measured: 6 months

  5. Psychological health

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2023
  2. Study start1 Sep 2020
  3. Primary completion31 Jul 2021
  4. Study completion31 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05933798
Sponsor's protocol ID
2020-QS-001
Status last verified
Jul 2023
First submitted
6 Jun 2023
Last updated
6 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 36098317

Questions about this trial

What is this clinical trial studying?

A study testing ICOPE in people with Aging and Healthy Aging, run by Pinetree Health Technologies (Beijing) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of implementing the ICOPE program in China (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05933798, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.

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