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

Duke University

Status: Enrolling

Conditions: Advance Care Planning; Heart Failure

Treatments: Other: My Voice

Study type: Interventional

Funder types: Other

Identifiers

NCT06090734

2022/2482

Details and patient eligibility

About

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.

Full 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

Enrollment: 244 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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244 participants in 2 patient groups

My Voice

Experimental group

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).

Treatment:

Other: My Voice

Control

No Intervention group

Description:

Control arm patients and caregivers will receive usual care.