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

ConditionsCarersPalliative CareNeeds AssessmentSupportive Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Hong Kong Polytechnic University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

adults ≥18 years old;

family members taking a primary role in patient care at home as nominated by the palliative cancer patient;

ability to communicate in Chinese.

Disqualifiers

paid caregivers;

unable to complete the questionnaire due to mental impairment determined by physicians.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CSNAT-I

    Other intervention

    CSNAT-I will be conducted in five stages, including an introduction of the CSNAT, family caregivers' consideration of needs, prioritize needs, a shared care plan, and a shared review for effectiveness and subsequent actions .

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: CSNAT-IExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Caregiver burden

13-item Caregiver Strain Index (CSI), each item with 1 ("yes") or 0("no") responses. The total score ranges from 0 to 13 and a higher score represents greater caregiver burden.

Time frame
From enrollment to the end of intervention at 4 weeks

Secondary outcomes

1

Caregiver distress

The Depression, Anxiety, and Stress Scale (DASS), 4-point Likert scale ranging from 0('did not apply to me at all") to 3('applied to me very much'). The scale has 3 subscales, and the subscale score is obtained by summing up the item scores. A possible score range of 0 to 21 is each subscale. A higher score indicates greater depression, anxiety and stress.

Time frame
From enrollment to the end of intervention at 4 weeks
2

Health-related quality of life

Quality of Life in Life-Threatening Illness-Family Carer (QOLLTI-F), assesses seven dimensions, encompassing environment, patient condition, your own condition, your outlook, quality of care, relationships, and financial worries. The rating scale of each tool ranges from 0 to 10, and the total score is 160 respectively, with a higher total score indicating better QOL.

Time frame
From enrollment to the end of intervention at 4 weeks
3

Reach

eligibility rate, consent rate, participation rate, and reasons for non-participation will be used to measure reach of the intervention. All data will be collected from the study screening log.

Time frame
Through study completion, an average of 6 months
4

Implementation

Fidelity, appropriateness and acceptability of the intervention, enablers and barriers to intervention implementation as well as the cost of the implementation. Fidelity of the intervention will be measured through the intervention delivery log. The appropriate and acceptability of the intervention, enablers and barriers to the intervention implementation will be collected using a self-designed questionnaire completed by participants. The cost of the implementation of the study will be calculated based on the time of interventionists for each intervention case multiplied by hourly salary determined by the hospital authority

Time frame
Through study completion, an average of 6 months.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hong Kong Polytechnic University

Lead sponsor

United Christian Hospital

Collaborator

Haven of Hope Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: