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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06090734
• Other study ID #: 2022/2482
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: February 2025

Study information

• Verified date: October 2023
• Source: Duke-NUS Graduate Medical School
• Contact: Chetna Malhotra, MD, MPH
• Phone: +65 65165692
• Email: chetna.malhotra[@]duke-nus.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 244
• Est. completion date: February 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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:

a) domestic helper

Related Conditions & MeSH terms

• Advance Care Planning
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Duke-NUS Graduate Medical School	Changi General Hospital, Khoo Teck Puat Hospital, National Heart Centre Singapore, Sengkang General Hospital, Singapore General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Proportion of patients who have ACP discussions with their caregivers	will be assessed from the survey	1 year from data collection
Primary	Proportion of patients who prefer life-extending treatments	will be assessed from the survey	1 year from data collection
Secondary	Proportion of patients with psychological distress	will be assessed from the survey	1 year from data collection
Secondary	Peace and acceptance scores	will be assessed from the survey	1 year from data collection
Secondary	Proportion of patients having decision maker	will be assessed from the survey	1 year from data collection