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

Официальное название

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

Обзор

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)

Вмешательства

• Поведенческое Careverse
  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 wish
• Другое Usual Care
  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.

Первичные конечные точки

• Advance Care Planning Engagement Survey for Surrogate Decision-Maker [Срок оценки: Baseline, 1-week, and 6-week]

Вторичные конечные точки (8)

• Satisfaction with care [Срок оценки: Baseline, 6-week, and 6-month]
• Satisfaction with care - Feeling Heard and Understood [Срок оценки: Baseline, 6-week, and 6-month]
• Goals of care [Срок оценки: Baseline, 1-week, 6-week, and 6-month]
• Caregivers Wellbeing [Срок оценки: Baseline, 1-week, 6-week, and 6-month]
• Caregiver quality of life - Mental health [Срок оценки: Baseline, 1-week, 6-week, and 6-month]
• Caregiver dyadic relationship [Срок оценки: Baseline, 1-week, 6-week, and 6-month]
• Patient Healthcare Utilisation [Срок оценки: Within six months pre-and post-intervention OR 12 months before death]
• Patient quality of life [Срок оценки: Baseline, 1-week, 6-week, and 6-month]

Критерии участия

1\. Patient Participants Inclusion Criteria:

• 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.

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:

• 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.

3\. Caregiver Participants Inclusion Criteria:

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

4\. Caregiver Participants Exclusion Criteria:

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Сингапур · 1 центр

• National University Hospital — Singapore

Публикации

• Huynh VA, Koh GCH, Lim MJR, Liew TM, Nga VDW, Yeo TT, Chan N, Tan JN, Sym FP. 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. Trials. 2026 Jun 25. doi: 10.1186/s13063-026-09876-0. Online ahead of print. PMID 42351230

Идентификаторы

NCT: NCT07134881 · ECOS 2025-0194

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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