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NCT01775436 · ClinicalTrials.gov registry record · NA
Palliative Care in People Living With HIV/AIDS: Integrating Into Standard of Care
A NA study of HIV, sponsored by Children's National Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 444
- Enrollment target
- 5
- Study locations
NCT01775436: Completed NA study of HIV, sponsored by Children's National Research Institute.
NCT01775436 is a NA study of HIV that has completed, run by Children's National Research Institute. The registered enrollment target is 444 participants, roughly in line with the 438-participant average among 303 other HIV trials with a reported enrollment target. The trial reports 5 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01775436, a NA study of HIV, has completed, sponsored by Children's National Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 444 participants
- Enrollment target
- 5
- Study locations
Study Summary
Our goal is to advance palliative care with persons living with AIDS (PLWA) or life-limiting co-morbidities to decrease suffering and increase quality of life (QOL). Left without advance care planning (ACP) for end-of-life decision, miscommunication and disagreements may result in families being charged with neglect or court battles over treatment choices, unmet care or delivery of unnecessary or unwanted care, and non-relative caregivers being dismissed (e.g. gay partners). We hope to increase families' understandings of their family member's wishes for end-of-life care to decrease conflict through the FAmily-CEntered Advance (FACE) Care Planning intervention. We will also study communication, quality of life, and spiritual struggle. Families will be randomized into either the Control (N=96 families) or the FACE Intervention (n=192 dyads). FACE families will meet with a trained/certified researcher for two 60-minute sessions scheduled one week apart: Session 1: The Respecting Choices Interview®; and Session 2: Completion of The Five Wishes©. Control families will also meet with a researcher for two 60-minute sessions scheduled one week apart: Session 1: Developmental History; and Session 2: Nutrition and Exercise. Questionnaires will be administered five times, Baseline and at 3, 6, 12 and 18 month post-intervention, for an average of 2 years. AIM 1. To determine the efficacy of FACE on congruence in treatment preferences between PLWA and their surrogates over time, and the effect of the pattern of congruence development trajectory on healthcare utilization (i.e., distal outcomes: number of hospitalizations, dialysis, ER visits). Hypothesis A: Development of congruence may not be homogeneous and FACE may influence the pattern of congruence development. Hypothesis B: Different patterns of congruence development may have different effects on health care utilization. Hypothesis C: Compared to Controls, FACE participants will better maintain congruence over time.
Primary Outcome
Measured by the Statement of Treatment Preferences. This measure was adapted using experts and community advisory board. It is a tool to express values and goals related to future medical decisions regarding frequently occurring situations specific to HIV/AIDS.Multiple Time Frames are needed as the Primary Outcome measure is going to report a change over time, per Aim 1: "to sustain congruence in treatment preferences between PLWA and their surrogate over time" compared to controls.
Conditions Studied
Interventions
- BEHAVIORAL FAmily-CEntered Advance Care Planning
- BEHAVIORAL Healthy Living Control
Study Locations (5)
District of Columbia
- Georgetown University Hospital - Washington D.C.
- Children's National Medical Center - Washington D.C.
- Institute for Clinical Research, Inc. (Affiliated with Department of Veterans Affairs Medical Center of Washington, DC) - Washington D.C.
- MedStar Health Research Institute/Washington Hospital Center - Washington D.C.
- George Washington University - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 444 participants |
| Start Date | 2013-10-13 |
| Est. Completion | 2017-03-28 |
| Phase | NA |
What the finished NCT01775436 record still lists
NCT01775436 is an interventional study that assigns participants to a tested intervention. The registered 444 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 438-participant average among 303 other HIV trials with a reported enrollment target.
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 2 interventions - of which FAmily-CEntered Advance Care Planning is the first listed.
NCT01775436 lists 5 locations in 1 state (District of Columbia).
Frequently Asked Questions
What is clinical trial NCT01775436 about?
NCT01775436 is a clinical study titled "Palliative Care in People Living With HIV/AIDS: Integrating Into Standard of Care". Our goal is to advance palliative care with persons living with AIDS (PLWA) or life-limiting co-morbidities to decrease suffering and increase quality of life (QOL). Left without advance care planning (ACP) for end-of-life decision, miscommunication and disagreements may result in families being cha...
What is the current status of trial NCT01775436?
This trial is currently completed. It is a NA study. The enrollment target is 444 participants. The study started on 2013-10-13. Estimated completion is 2017-03-28.
What conditions does trial NCT01775436 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT01775436?
The interventions under investigation include: FAmily-CEntered Advance Care Planning (BEHAVIORAL), Healthy Living Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT01775436?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01775436 being conducted?
This trial has 5 study locations across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01775436's enrollment target sits among peer trials
444 37th of 303 higher than 267 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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