Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02299180 |
Date of registration:
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18/11/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Impact of Advance Care Planning on Care for Patients With Advanced Heart Failure
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Scientific title:
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Impact of Advance Care Planning on Care for Patients With Advanced Heart Failure: A Randomized Controlled Trial |
Date of first enrolment:
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February 2015 |
Target sample size:
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282 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02299180 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Chetna Malhotra, MD, MPH |
Address:
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Telephone:
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Email:
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Affiliation:
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Duke-NUS Graduate Medical School |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Patient participant:
- Patients must be 21 years old or older and must be diagnosed with advanced heart
failure (New York Heart Association Class III and IV). Patients must be aware of their
diagnosis
- Caregiver/Decision-maker participant: Subject must be 21 years old or older
Participant must be either
- appointed substitute decision maker or
- most likely to be substitute decision maker for patient (if patient were to lose
decision-making capacity)
Exclusion Criteria:
- Patient participant: Patients must not have any psychiatric or cognitive disorders
- Caregiver/Decision-maker participant: Cannot be a maid or foreign domestic worker
Age minimum:
21 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Heart Failure
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Intervention(s)
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Behavioral: ACP
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Primary Outcome(s)
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Proportion of patients receiving end of life care consistent with their stated preferences
[Time Frame: one year]
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Secondary Outcome(s)
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Patient scores for Quality of life
[Time Frame: every four months for one year]
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Patient scores for anxiety and depression
[Time Frame: every four months for one year]
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Total health care expenditure of patients during study duration
[Time Frame: one year]
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Patient's understanding of own illness
[Time Frame: every four months for one year]
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Patient's participation in decision-making
[Time Frame: every four months for one year]
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Secondary ID(s)
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LCPC IN14-0001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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