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

Sponsor
Duke-NUS Graduate Medical School (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06090734
Collaborator
Changi General Hospital (Other), Singapore General Hospital (Other), Sengkang General Hospital (Other), National Heart Centre Singapore (Other), Khoo Teck Puat Hospital (Other)
244
Enrollment
2
Arms
15
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: My Voice
 N/A

Detailed Description

The research study consists of 3 phases:

  1. Usability testing - to assess the usability of 'My Voice' with patients with heart failure, their caregivers and healthcare providers,

  2. Pilot testing - to test the feasibility of implementation and workflow of 'My Voice' and the survey questionnaires with a small group of participants and,

  3. Randomized controlled trial- to evaluate the effectiveness of 'My Voice' with a control group who do not receive the intervention in improving patient outcomes

Study Design

Study Type:
Interventional
Anticipated Enrollment :
244 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Development and Evaluation of 'My Voice': A Randomized Controlled Trial
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: My Voice

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
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.
No Intervention: Control

Control arm patients and caregivers will receive usual care.

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients who have ACP discussions with their treating doctor at least once during the study period [1 year from data collection]

    will be assessed from medical records and survey

  2. Proportion of patients who have ACP discussions with their caregivers [1 year from data collection]

    will be assessed from the survey

  3. Proportion of patients who prefer life-extending treatments [1 year from data collection]

    will be assessed from the survey

Secondary Outcome Measures

  1. Proportion of patients with psychological distress [1 year from data collection]

    will be assessed from the survey

  2. Peace and acceptance scores [1 year from data collection]

    will be assessed from the survey

  3. Proportion of patients having decision maker [1 year from data collection]

    will be assessed from the survey

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • The inclusion criteria for patients are

  1. Age ≥ 21 years old

  2. Singaporean or Permanent Resident

  3. Diagnosed with heart failure

  4. Symptoms classified under NYHA class II (with an ejection fraction of less than or equal to 35%), III or IV

  5. Intact cognition determined through the Abbreviated Mental Test (AMT) (for pilot testing and main RCT)

  6. Ability to speak and read English, Mandarin or Malay

  7. Willing to complete a web intervention

  8. Easily contactable via mobile phone or landline

  9. Have a permanent address in Singapore for at least the next 1 year

  10. Not recruited in a previous phase of the study

The inclusion criteria for caregivers are

  1. Age ≥ 21 years old

  2. Nominated as a healthcare spokesperson by the patient or the main decision maker for the patient (for intervention arm only)

  3. Ability to speak and read English, Mandarin or Malay

  4. Willing to complete a web intervention

  5. Easily contactable via mobile phone or landline

  6. Have a permanent address in Singapore for at least the next 1 year

Exclusion criteria for caregivers are:
  1. domestic helper

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Duke-NUS Graduate Medical School
  • Changi General Hospital
  • Singapore General Hospital
  • Sengkang General Hospital
  • National Heart Centre Singapore
  • Khoo Teck Puat Hospital

Investigators

  • Principal Investigator: Chetna Malhotra, Duke-NUS Graduate Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chetna Malhotra, Assistant Professor, Duke-NUS Graduate Medical School
ClinicalTrials.gov Identifier:
NCT06090734
Other Study ID Numbers:
  • 2022/2482
First Posted:
Oct 19, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Oct 23, 2023