Clinical trial NCT06090734: 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
Overall status: RECRUITING
Phase: NA
Conditions: Advance Care Planning
Heart Failure
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
Collaborators: name: Changi General Hospital
name: Singapore General Hospital
name: Sengkang General Hospital
name: National Heart Centre Singapore
name: Khoo Teck Puat Hospital
First posted: 2023-10-19
Enrollment: 244
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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

Eligibility 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

Primary outcomes:
measure: Proportion of patients who have ACP discussions with their treating doctor at least once during the study period
timeFrame: 1 year from data collection
measure: Proportion of patients who have ACP discussions with their caregivers
timeFrame: 1 year from data collection
measure: Proportion of patients who prefer life-extending treatments
timeFrame: 1 year from data collection
Secondary outcomes:
measure: Proportion of patients with psychological distress
timeFrame: 1 year from data collection
measure: Peace and acceptance scores
timeFrame: 1 year from data collection
measure: Proportion of patients having decision maker
timeFrame: 1 year from data collection
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Duke-NUS
Study officials:
affiliation: Duke-NUS Graduate Medical School
name: Chetna Malhotra
role: PRINCIPAL_INVESTIGATOR
References: