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

NCT07134881 | Recruiting

• 1 other identifier: ECOS 2025-0194
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

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

Keywords

randomised control trial; digital intervention; advance care planning; goals of care; palliative care

Outcome Measures

Primary Outcomes (1)

• Advance Care Planning Engagement Survey for Surrogate Decision-Maker

  The 17-item ACP Surrogate Decision Making Instrument (ACP-17 SDM) developed by Sudore et. al., is a validated questionnaire designed to assess how engaged surrogate decision makers (SDMs) are in the advance care planning process. The ACP-17 SDM measures engagement across three domains: 1) Serving as SDM (7 items), 2) Contemplation (4 items), and 3) Readiness (6 items). Each item is answered on a 5-point Likert scale (1 = not at all/never, to 5 = extremely/A lot), and higher mean scores (range: 1.0 - 5.0) indicate higher engagement in ACP by the surrogate. Van Scoy, Lauren J., et al. "Adaptation and preliminary validation of the advance care planning engagement survey for surrogate decision makers." Journal of pain and symptom management 57.5 (2019): 980-988.

  Baseline, 1-week, and 6-week

Secondary Outcomes (8)

• Satisfaction with care

  Baseline, 6-week, and 6-month

• Satisfaction with care - Feeling Heard and Understood

  Baseline, 6-week, and 6-month

• Goals of care

  Baseline, 1-week, 6-week, and 6-month

• Caregivers Wellbeing

  Baseline, 1-week, 6-week, and 6-month

• Caregiver quality of life - Mental health

  Baseline, 1-week, 6-week, and 6-month

Study Arms (2)

Comparator arm

ACTIVE COMPARATOR

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.

Other: Usual Care

Intervention arm

EXPERIMENTAL

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.

Behavioral: Careverse

Interventions

Careverse BEHAVIORAL

Careverse is a digital psychoeducational website designed to assist caregivers and patients to clarify their values, end-of-life preferences, enable surrogates to further their understanding of the patient's wishes, and prepare surrogates for the role and responsibilities of a medical decision maker. The intervention consists of values elicitation tools, educational materials, and testimonies. The participants will receive guides on how to initiate/re-introduce discussions about end-of-life wishes with their loved ones and clinicians.

Intervention arm

Usual Care OTHER

Caregivers in the comparator arm will receive a digital version of standard advanced care planning education material prepared by Agency of Integrated Care. The ACP Workbook is created by AIC to help individuals explore their values, care preferences, and end-of-life goals in a structured, reflective way.

Comparator arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singapore resident aged 21years and above,
• patient able to identify one main caregiver in the care and medical decision-making for the patient;
• patient able to communicate in either English, Chinese, Malay or Tamil;
• patient meeting one of the following illness criteria: 4a. Patients with brain tumours: histological and/or radiological diagnosis of glioma or brain metastases.
• b. Patients with spontaneous intracerebral haemorrhage (SICH) based on radiological diagnosis of SICH on baseline computed-tomographic scans.
• c. 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.

You may not qualify if:

• Patients unable to identify a caregiver who is a medical decision-maker,
• Patients are currently or was previously healthcare workers; or
• Patients are diagnosed with dementia or deemed cognitively impaired as determined by the Abbreviated Mental Test.
• caregivers are identified as a medical decision-maker for the patient
• Singapore resident aged 21 years and above; and
• able to communicate in English
• caregivers are currently or were previously healthcare workers;
• 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
• caregivers diagnosed with dementia.

Sponsors & Collaborators

• National University of Singapore: lead
• National University Hospital, Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Study Officials

• Gerald Choon Huat Koh, PhD(FM)

  Saw Swee Hock School of Public Health, National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Treatment allocation will be masked from participants for the entirety of the study. We do not anticipate unblinding of participants to treatment status. Effort to maintain blinding of participants include training our research coordinators (RCs) to strictly follow a protocol and script in all interactions with participants. RCs are blinded of treatment allocation during recruitment, consent-taking and baseline survey process, minimising the risk of selection bias. Once participants are randomised into their allocated arm, RCs will be aware of the participant's treatment allocation as RCs will need to ensure that participants successfully complete the signup process required for the intervention arm. Risks of unmasking caregivers participants is minimal as followup questionnaires are completed via self-administered online survey without the RCs being present.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study is a single-blind, participant-level randomised trial. Upon providing consent and completion of the baseline survey, enrolled caregiver participants will be randomly assigned 1:1 to the experimental and comparator arms using the built-in randomizer function in the online survey software (Qualtrics). Balance between the allocation arms will be achieved by stratifying based on illness.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)