Clinical impact and cost-effectiveness of the WHO integrated care for older people (ICOPE) Intervention for older adults with intrinsic capacity decline in primary health care facilities in China: study protocol for a cluster-randomised controlled trial

This cluster-randomised trial aims to evaluate the effectiveness of the WHO Integrated Care for Older People (ICOPE) intervention for community-dwelling older adults with declining intrinsic capacity in China, incorporating a cost-effectiveness analysis from a healthcare system perspective. This study will employ a community-based, cluster randomised controlled trial design. A total of 1,400 participants with declining intrinsic capacity aged ≥ 60 years will be recruited from 37 health service stations affiliated with seven community health service centres (CHCs) in Beijing. Within each CHC, clusters will be randomised to either the ICOPE intervention group or the standard health management care group. The ICOPE intervention will comprise a 4-month program featuring structured group health education sessions, group practice activities and online health education delivered via WeChat. Educational content will target six domains of intrinsic capacity: cognitive function, vitality/nutrition, sensory ability, psychological well-being, mobility and traditional Chinese medicine-based approaches. The primary outcomes will include health status and economic evaluations assessed at 12 and 24 months post-intervention. Health outcomes will encompass physical function, cognitive capacity, vitality, mobility, vision capacity, hearing capacity and psychological health. The economic evaluation will assess incremental cost-effectiveness based on quality-adjusted life-years gained, as measured by the EuroQol five-dimensional questionnaire (EQ-5D), using a 12-month time horizon. This trial will generate critical evidence on the effectiveness and cost implications of the WHO ICOPE integrated care model when implemented in a Chinese community setting.This study will provide research evidence on effectiveness and cost-effectiveness of the ICOPE intervention among community-dwelling older adults with declining intrinsic capacity in China. Findings will inform policy and practice development. The trial has been registered in the Chinese Clinical Trial Registry (ID: ChiCTR 2400090521). Date of registration: 08/10/2024.