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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

‣ \- 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

Locations
Other Locations
Singapore
Duke-NUS
RECRUITING
Singapore
Contact Information
Primary
Chetna Malhotra, MD, MPH
chetna.malhotra@duke-nus.edu.sg
+65 65165692
Time Frame
Start Date: 2024-03-07
Estimated Completion Date: 2026-02
Participants
Target number of participants: 244
Treatments
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).
No_intervention: Control
Control arm patients and caregivers will receive usual care.
Related Therapeutic Areas
Sponsors
Collaborators: Sengkang General Hospital, Singapore General Hospital, Khoo Teck Puat Hospital, Changi General Hospital, National Heart Centre Singapore
Leads: Duke-NUS Graduate Medical School

This content was sourced from clinicaltrials.gov