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

Primary Purpose

Advance Care Planning, Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
My Voice
Sponsored by
Duke-NUS Graduate Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Advance Care Planning

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    My Voice

    Control

    Arm Description

    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).

    Control arm patients and caregivers will receive usual care.

    Outcomes

    Primary Outcome Measures

    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
    Proportion of patients who have ACP discussions with their caregivers
    will be assessed from the survey
    Proportion of patients who prefer life-extending treatments
    will be assessed from the survey

    Secondary Outcome Measures

    Proportion of patients with psychological distress
    will be assessed from the survey
    Peace and acceptance scores
    will be assessed from the survey
    Proportion of patients having decision maker
    will be assessed from the survey

    Full Information

    First Posted
    October 13, 2023
    Last Updated
    October 18, 2023
    Sponsor
    Duke-NUS Graduate Medical School
    Collaborators
    Changi General Hospital, Singapore General Hospital, Sengkang General Hospital, National Heart Centre Singapore, Khoo Teck Puat Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06090734
    Brief Title
    Development and Evaluation of 'My Voice': A Randomized Controlled Trial
    Official Title
    Development and Evaluation of 'My Voice': A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    November 2024 (Anticipated)
    Study Completion Date
    February 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Duke-NUS Graduate Medical School
    Collaborators
    Changi General Hospital, Singapore General Hospital, Sengkang General Hospital, National Heart Centre Singapore, Khoo Teck Puat Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advance Care Planning, Heart Failure

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    244 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    My Voice
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Control arm patients and caregivers will receive usual care.
    Intervention Type
    Other
    Intervention Name(s)
    My Voice
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Proportion of patients who have ACP discussions with their treating doctor at least once during the study period
    Description
    will be assessed from medical records and survey
    Time Frame
    1 year from data collection
    Title
    Proportion of patients who have ACP discussions with their caregivers
    Description
    will be assessed from the survey
    Time Frame
    1 year from data collection
    Title
    Proportion of patients who prefer life-extending treatments
    Description
    will be assessed from the survey
    Time Frame
    1 year from data collection
    Secondary Outcome Measure Information:
    Title
    Proportion of patients with psychological distress
    Description
    will be assessed from the survey
    Time Frame
    1 year from data collection
    Title
    Peace and acceptance scores
    Description
    will be assessed from the survey
    Time Frame
    1 year from data collection
    Title
    Proportion of patients having decision maker
    Description
    will be assessed from the survey
    Time Frame
    1 year from data collection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chetna Malhotra, MD, MPH
    Phone
    +65 65165692
    Email
    chetna.malhotra@duke-nus.edu.sg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chetna Malhotra
    Organizational Affiliation
    Duke-NUS Graduate Medical School
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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