NCT05933798

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. 1.Whether it is feasible to implement the ICOPE approach in China;
  2. 2.Whether the integrated care approach would make any difference in health outcomes and resource utilization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

June 6, 2023

Last Update Submit

July 2, 2023

Conditions

Keywords

integrated careprimary careICOPEdecade of healthy ageing

Outcome Measures

Primary Outcomes (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).

    12 months

Secondary Outcomes (5)

  • Independence

    6 months

  • Cognition

    6 months

  • Vitality

    6 months

  • Mobility

    6 months

  • Psychological health

    6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

Pariticpants who continued receiving usual care during the study period.

Other: Usual Care

Interventions

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

Intervention Group

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

Control Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pinetree Care Group

Beijing, 100029, China

Location

Related 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.

    PMID: 36098317BACKGROUND

Related Links

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Ninie Wang, MBA DrPH

    Pinetree Care Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

July 6, 2023

Study Start

September 1, 2020

Primary Completion

July 31, 2021

Study Completion

August 31, 2021

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

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.

Locations