NAVIGATE — digital support to help caregivers navigate goals of care and advance planning

Navigating Advanced Illness Goals And Treatment With Digital Engagement (NAVIGATE): A Randomised Control Trial

This project tests whether a digital interactive website helps caregivers of seriously ill patients do more advance care planning than a standard digital booklet.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: National University of Singapore (Academic / other)
• Locations: 1 site (Singapore)
• Trial ID: NCT07134881 on ClinicalTrials.gov

What this trial studies

This two-arm, parallel-design interventional trial randomizes caregivers to either an interactive digital website (Careverse) or a usual-care digital booklet and measures changes in advance care planning engagement. Caregiver participants explore the assigned digital material and complete self-administered questionnaires at baseline, one week, six weeks, and six months, while patients provide observational data via interviewer-administered questionnaires on the same schedule. Eligible patients are Singapore residents aged 21 or older with an identified caregiver and predefined serious illnesses (glioma or brain metastases, spontaneous intracerebral haemorrhage, or chronic kidney disease stage 4–5) for whom clinicians consider ACP appropriate. The trial is led by the National University of Singapore and recruits through National University Hospital, with the intervention delivered digitally in English, Chinese, Malay, or Tamil.

Who should consider this trial

Good fit: Ideal participants are caregivers of Singaporean adults (21+) with serious illness (brain tumour, spontaneous intracerebral haemorrhage, or CKD stage 4–5) who can read English, Chinese, Malay, or Tamil and are willing to use online materials and complete four questionnaires.

Not a fit: Patients without an identified caregiver, those not meeting the specified illness criteria, those outside Singapore, or caregivers unable or unwilling to use digital tools are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the website could increase caregiver engagement in advance care planning, leading to clearer documentation of patients' wishes and care that better matches their goals.

How similar studies have performed: Previous digital and educational interventions for advance care planning have shown mixed but sometimes positive effects on documentation and discussions, although caregiver-focused interactive website trials are still relatively limited.

Eligibility criteria

1\. Patient Participants Inclusion Criteria:

1. Singapore resident aged 21years and above,
2. patient able to identify one main caregiver in the care and medical decision-making for the patient;
3. patient able to communicate in either English, Chinese, Malay or Tamil;
4. patient meeting one of the following illness criteria: 4a. Patients with brain tumours: histological and/or radiological diagnosis of glioma or brain metastases.

4b. Patients with spontaneous intracerebral haemorrhage (SICH) based on radiological diagnosis of SICH on baseline computed-tomographic scans.

4c. Patients with CKD Stage 4 and 5, identified at G4 or G5 of CKD, glomerular filtration rate (GFR) 30 ml/min or less, inclusive of kidney failure on kidney replacement therapy; and (5) Physicians assessment that ACP is appropriate for the patient by physicians.\* (\*) The attending clinicians may base the assessment of ACP appropriateness on several factors in addition to high mortality risk. As a baseline, clinicians are asked to base their assessment of high mortality risk using the validated "Surprise" question.

2\. Patient participants Exclusion Criteria:

1. Patients unable to identify a caregiver who is a medical decision-maker,
2. Patients are currently or was previously healthcare workers; or
3. Patients are diagnosed with dementia or deemed cognitively impaired as determined by the Abbreviated Mental Test.

3\. Caregiver Participants Inclusion Criteria:

1. caregivers are identified as a medical decision-maker for the patient
2. Singapore resident aged 21 years and above; and
3. able to communicate in English

4\. Caregiver Participants Exclusion Criteria:

1. caregivers are currently or were previously healthcare workers;
2. caregivers not involved in primary care of the patient (including providing care to the patient, supervision of care, or involved in making decisions regarding treatment the patient receives); or
3. caregivers diagnosed with dementia.

Where this trial is running

Singapore

• National University Hospital — Singapore, Singapore (Recruiting)

Study contacts

• Principal investigator: Gerald Choon Huat Koh, PhD(FM) — Saw Swee Hock School of Public Health, National University of Singapore

Conditions Paliative Care; Advance Care Planning; Digital Education Interventions; Values, Social; Goals of Care; randomised control trial; digital intervention; advance care planning