Navigating Advanced Illness Goals And Treatment With Digital Engagement (NAVIGATE)

National University of Singapore

Status: Enrolling

Conditions: Advance Care Planning; Digital Education Interventions; Goals of Care; Paliative Care; Values, Social

Treatments: Other: Usual Care; Behavioral: Careverse

Study type: Interventional

Funder types: Other

Identifiers

NCT07134881

ECOS 2025-0194

Details and patient eligibility

About

The goal of this two-armed, parallel-design, pre-/post-intervention assessment clinical trial is to learn if a digital and interactive website helps to improve advance care planning (ACP) engagement among caregivers of patients with serious illness. The main questions it aims to answer are:

Does the website increase ACP engagement of caregivers of patients with serious illness? Researchers will compare the digital and interactive website to the usual care (a digital booklet) to see if the digital intervention works to improve ACP engagement among caregivers.

Participants who are caregivers will:

• Be introduced to a digital website and asked to explore the site over the course of the study.
• Complete four self-administered questionnaires (baseline, one-week, six-week, and six-month).

Participants who are patients will not have any intervention assigned and will only have their observational data collected through four interviewer-administered questionnaires (baseline, one-week, six-week, and six-month)

Enrollment: 200 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Comparator arm

Active Comparator group

Description:

For caregiver participants: Usual care. For patient participants: usual care, as prescribed by the clinical care team, is unaffected by the study design and we only conduct observational measurements of patient participants during the course of the study.

Treatment:

Other: Usual Care

Intervention arm

Experimental group

Description:

For caregiver participants: Enrolled caregiver participants randomised in the intervention arm will be directed to the intervention digital website and guided through the signup process. Once logged in, they are asked to explore and use the website contents and tools in their own time. For patient participants: usual care, as prescribed by the clinical care team, is unaffected by the study design and we only conduct observational measurements of patient participants during the course of the study.

Treatment:

Behavioral: Careverse