NAVIGATE Study Testing a Digital Website to Support Caregivers of Seriously Ill Patients in Advance Care Planning Engagement
Led by National University of Singapore · Updated on 2025-09-15
200
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether a digital and interactive website can improve advance care planning ACP engagement among caregivers of patients with serious illness. This clinical trial compares the use of a digital website called Careverse to usual care, which involves a digital booklet, to see which better supports caregivers in understanding and discussing end-of-life values and preferences. The study is designed as a two-armed, randomized trial with a pre- and post-intervention assessment format.
Caregiver participants will be randomly assigned to either the intervention group, who will use the Careverse website with tools and educational content to help clarify values and prepare for medical decision-making, or the usual care group, who will receive a standard digital ACP booklet. Patient participants will not receive any intervention but will be observed through scheduled questionnaires. The trial includes four self-administered questionnaires for caregivers and interviewer-administered questionnaires for patients at baseline, one week, six weeks, and six months.
Participants will complete questionnaires measuring ACP engagement, satisfaction with care, goals of care, caregiver well-being, quality of life, and patient healthcare utilization during the study. Researchers will monitor these outcomes at multiple time points up to six months to understand the impact of the digital intervention. The study will last up to six months for each participant, with data collection focused on both caregivers and patients under usual care conditions.
CONDITIONS
Brief Title
Navigating Advanced Illness Goals And Treatment With Digital Engagement (NAVIGATE)
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Patient participants must be Singapore residents aged 21 years and above
Patients must be able to identify one main caregiver involved in care and medical decisions
Patients must communicate in English, Chinese, Malay, or Tamil
Patients must have one of the following: brain tumors (glioma or brain metastases), spontaneous intracerebral hemorrhage, or stage 4 or 5 chronic kidney disease
Physicians must assess that advance care planning is appropriate for the patient
Caregiver participants must be identified as medical decision-makers for the patient
Caregivers must be Singapore residents aged 21 years and above
Caregivers must be able to communicate in English
You will not qualify if you...
Patients unable to identify a caregiver who is a medical decision-maker
Patients currently or previously employed as healthcare workers
Patients diagnosed with dementia or deemed cognitively impaired
Caregivers currently or previously employed as healthcare workers
Caregivers not involved in primary care or decision-making for the patient
Caregivers diagnosed with dementia
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) to confirm eligibility and enroll participants
Outpatient Treatment
Duration - 6 weeks
Caregiver participants randomized to the intervention arm use the Careverse digital psychoeducational website at their own pace to clarify values and prepare for medical decision-making. Caregiver participants in the comparator arm receive a digital version of standard advanced care planning education materials. Patient participants receive usual care as prescribed by their clinical team and are observed.
Baseline, 1-week, and 6-week assessments for caregivers and patients
Follow-up
Duration - Up to 6 months after treatment
Participants complete additional assessments to evaluate satisfaction with care, goals of care, caregiver wellbeing, and patient quality of life up to 6 months after the intervention period.
Assessments at 6-week and 6-month timepoints
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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NAVIGATE Study Testing a Digital Website to Support Caregivers of Seriously Ill Patients in Advance Care Planning Engagement
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Published Research Related To This Trial
Navigating Advanced Illness Goals And Treatment with Digital Engagement (NAVIGATE): a protocol for a randomised controlled trial of a website for caregivers of patients with serious illness.
Vinh Anh Huynh, Gerald Choon Huat Koh, Mervyn Jun Rui Lim...