A Pilot Effectiveness and Implementation Trial of CSNAT-I in Hong Kong

In this hybrid Type 1 effectiveness-implementation pilot randomized controlled trial, 60 caregivers will be randomized into either the CSNAT-I group or usual care. Preliminary effectiveness outcomes include caregiver burden, distress, and health-related quality of life. Preliminary implementation outcomes include feasibility, fidelity, appropriateness, acceptability, cost of the intervention, as well as barriers and facilitators to intervention implementation. Quantitative data will be analyzed using descriptive analysis and linear mixed effects model, while qualitative data using thematic analysis. The CSNAT-I is expected to be preliminarily effective in improving caregiver outcomes and implementable in Hong Kong palliative care context, which will serve as the foundation for a large trial before integration into daily practice.

NCT Number	NCT07193433
Lead Sponsor	The Hong Kong Polytechnic University Collaborators: United Christian Hospital, Haven of Hope Hospital
Conditions	Carers, Palliative Care, Needs Assessment, Supportive Care
Enrollment	60 participants
Start Date	2025-09-20
Primary Completion	2026-03-20 (estimated)
Study Completion	2026-05-20 (estimated)
Updated on ClinicalTrials.gov	2025-09-25