Development and Evaluation of 'My Voice': A Randomized Controlled Trial

Study Overview
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Brief Summary
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The study aims to develop and evaluate a web-based interactive platform (called 'My Voice') that helps to educate patients with heart failure and their caregivers about heart failure, identify their goals for end-of-life care, and share these with their caregivers and doctors.

Detailed Description
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The research study consists of 3 phases: Usability testing - to assess the usability of 'My Voice' with patients with heart failure, their caregivers and healthcare providers, Pilot testing - to test the feasibility of implementation and workflow of 'My Voice' and the survey questionnaires with a small group of participants and, Randomized controlled trial- to evaluate the effectiveness of 'My Voice' with a control group who do not receive the intervention in improving patient outcomes

Official Title
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Development and Evaluation of 'My Voice': A Randomized Controlled Trial

Conditions
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Advance Care Planning, Heart Failure

Intervention / Treatment
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* Other: My Voice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - The inclusion criteria for patients are Age ≥ 21 years old Singaporean or Permanent Resident Diagnosed with heart failure Symptoms classified under NYHA class II (with an ejection fraction of less than or equal to 35%), III or IV Intact cognition determined through the Abbreviated Mental Test (AMT) (for pilot testing and main RCT) Ability to speak and read English, Mandarin or Malay Willing to complete a web intervention Easily contactable via mobile phone or landline Have a permanent address in Singapore for at least the next 1 year Not recruited in a previous phase of the study The inclusion criteria for caregivers are Age ≥ 21 years old Nominated as a healthcare spokesperson by the patient or the main decision maker for the patient (for intervention arm only) Ability to speak and read English, Mandarin or Malay Willing to complete a web intervention Easily contactable via mobile phone or landline Have a permanent address in Singapore for at least the next 1 year Exclusion criteria for caregivers are: a) domestic helper

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: My Voice<br>Intervention arm patients will complete the patient version of 'My Voice' at least once every 3 months for 1 year or until they pass away (whichever is earlier). Caregivers of patients in the intervention arm will complete the caregiver version of 'My Voice' at least once every 3 months for 1 year (or until the patient passes away, whichever is earlier). | Other: My Voice<br>* The web intervention educates patients about their illness and supports them to make their own Advance Care Planning decisions, update these decisions frequently as their clinical condition changes, and to make the ACP process easier and more accessible. The intervention aims to shift implementation of ACP from a provider-led one-time model to a patient-led dynamic model.<br>|
| No Intervention: Control<br>Control arm patients and caregivers will receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who have ACP discussions with their treating doctor at least once during the study period | will be assessed from medical records and survey | 1 year from data collection | 
| Proportion of patients who have ACP discussions with their caregivers | will be assessed from the survey | 1 year from data collection | 
| Proportion of patients who prefer life-extending treatments | will be assessed from the survey | 1 year from data collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with psychological distress | will be assessed from the survey | 1 year from data collection | 
| Peace and acceptance scores | will be assessed from the survey | 1 year from data collection | 
| Proportion of patients having decision maker | will be assessed from the survey | 1 year from data collection |