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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06090734
Other study ID # 2022/2482
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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