Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 10:58 PM
Study NCT ID:
NCT06090734
Status:
RECRUITING
Last Update Posted:
2025-03-21
First Post:
2023-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Evaluation of 'My Voice': a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 244}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2023-10-13', 'studyFirstSubmitQcDate': '2023-10-13', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'will be assessed from medical records and survey'}, {'measure': 'Proportion of patients who have ACP discussions with their caregivers', 'timeFrame': '1 year from data collection', 'description': 'will be assessed from the survey'}, {'measure': 'Proportion of patients who prefer life-extending treatments', 'timeFrame': '1 year from data collection', 'description': 'will be assessed from the survey'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with psychological distress', 'timeFrame': '1 year from data collection', 'description': 'will be assessed from the survey'}, {'measure': 'Peace and acceptance scores', 'timeFrame': '1 year from data collection', 'description': 'will be assessed from the survey'}, {'measure': 'Proportion of patients having decision maker', 'timeFrame': '1 year from data collection', 'description': 'will be assessed from the survey'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advance Care Planning', 'Heart Failure']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "The research study consists of 3 phases:\n\n1. Usability testing - to assess the usability of 'My Voice' with patients with heart failure, their caregivers and healthcare providers,\n2. Pilot testing - to test the feasibility of implementation and workflow of 'My Voice' and the survey questionnaires with a small group of participants and,\n3. Randomized controlled trial- to evaluate the effectiveness of 'My Voice' with a control group who do not receive the intervention in improving patient outcomes"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- The inclusion criteria for patients are\n\n1. Age ≥ 21 years old\n2. Singaporean or Permanent Resident\n3. Diagnosed with heart failure\n4. Symptoms classified under NYHA class II (with an ejection fraction of less than or equal to 35%), III or IV\n5. Intact cognition determined through the Abbreviated Mental Test (AMT) (for pilot testing and main RCT)\n6. Ability to speak and read English, Mandarin or Malay\n7. Willing to complete a web intervention\n8. Easily contactable via mobile phone or landline\n9. Have a permanent address in Singapore for at least the next 1 year\n10. Not recruited in a previous phase of the study\n\nThe inclusion criteria for caregivers are\n\n1. Age ≥ 21 years old\n2. Nominated as a healthcare spokesperson by the patient or the main decision maker for the patient (for intervention arm only)\n3. Ability to speak and read English, Mandarin or Malay\n4. Willing to complete a web intervention\n5. Easily contactable via mobile phone or landline\n6. Have a permanent address in Singapore for at least the next 1 year\n\nExclusion criteria for caregivers are:\n\na) domestic helper'}, 'identificationModule': {'nctId': 'NCT06090734', 'briefTitle': "Development and Evaluation of 'My Voice': a Randomized Controlled Trial", 'organization': {'class': 'OTHER', 'fullName': 'Duke-NUS Graduate Medical School'}, 'officialTitle': "Development and Evaluation of 'My Voice': a Randomized Controlled Trial", 'orgStudyIdInfo': {'id': '2022/2482'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'My Voice', '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).\n\nCaregivers 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).", 'interventionNames': ['Other: My Voice']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control arm patients and caregivers will receive usual care.'}], 'interventions': [{'name': 'My Voice', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['My Voice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '169857', 'city': 'Singapore', 'state': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'facility': 'Duke-NUS', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Chetna Malhotra, MD, MPH', 'role': 'CONTACT', 'email': 'chetna.malhotra@duke-nus.edu.sg', 'phone': '+65 65165692'}], 'overallOfficials': [{'name': 'Chetna Malhotra', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke-NUS Graduate Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke-NUS Graduate Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Changi General Hospital', 'class': 'OTHER'}, {'name': 'Singapore General Hospital', 'class': 'OTHER'}, {'name': 'Sengkang General Hospital', 'class': 'OTHER'}, {'name': 'National Heart Centre Singapore', 'class': 'OTHER'}, {'name': 'Khoo Teck Puat Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chetna Malhotra', 'investigatorAffiliation': 'Duke-NUS Graduate Medical School'}}}}