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NCT03118752 · ClinicalTrials.gov registry record · NA
Pragmatic Collaborative Care for Cardiac Inpatients With Depression or Anxiety
A NA study of Depression and Heart Failure, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 290
- Enrollment target
- 3
- Study locations
NCT03118752: Completed NA study of Depression and Heart Failure, sponsored by Massachusetts General Hospital.
NCT03118752 is a NA study of Depression and Heart Failure that has completed, run by Massachusetts General Hospital. The registered enrollment target is 290 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (63% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03118752, a NA study of Depression and Heart Failure, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 290 participants
- Enrollment target
- 3
- Study locations
Study Summary
The investigators will complete a pragmatic randomized trial (N=260 randomized participants) of the 26-week blended collaborative care (CC) intervention compared to enhanced usual care (eUC) in patients admitted for acute coronary syndrome (ACS) or heart failure (HF) found to have current depression, generalized anxiety disorder (GAD), or panic disorder (PD). The CC intervention will use a novel three-pronged approach to these high-risk patients. Care managers will provide centralized care coordination and specific interventions targeting: (1) the psychiatric disorders, (2) cardiac health behaviors, and (3) the cardiac illness. The primary study outcome will be physical function at 26 weeks, measured by the Duke Activity Status Index (DASI), given links between function and new cardiac events. The investigators will also examine effects on numerous other outcomes important to patients and healthcare systems. Specific Aim 1 \[patient-centered outcomes-primary aim\]: To compare between-group differences in the CC and eUC conditions on improvements in physical function, health-related quality of life, mental health, patient satisfaction, and other key patient-reported outcomes at 26 and 52 weeks. Specific Aim 2 \[adherence and medical outcomes\]: To compare between-group differences on health behaviors (physical activity, diet, smoking, medication adherence) and major adverse cardiac events. Specific Aim 3 \[cost\]: To compare healthcare costs between groups and assess the cost-effectiveness of CC. Hypotheses: The investigators expect this bolstered CC program to be associated with superior improvements in physical function, health-related quality of life, patient satisfaction, and adherence at 26 weeks, with promising effects on major adverse cardiac events. The investigators likewise expect the intervention to be cost-effective (\<$10,000/quality-adjusted life year) over the study period.
Primary Outcome
Physical function will be assessed with the Duke Activity Status Index (DASI).
Conditions Studied
Interventions
- BEHAVIORAL Collaborative Care
Study Locations (3)
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
- Salem Hospital - Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2017-10-16 |
| Est. Completion | 2024-03-08 |
| Phase | NA |
What the finished NCT03118752 record still lists
NCT03118752 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (63% lower).
The record links to 5 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Collaborative Care is the first listed.
NCT03118752 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03118752 about?
NCT03118752 is a clinical study titled "Pragmatic Collaborative Care for Cardiac Inpatients With Depression or Anxiety". The investigators will complete a pragmatic randomized trial (N=260 randomized participants) of the 26-week blended collaborative care (CC) intervention compared to enhanced usual care (eUC) in patients admitted for acute coronary syndrome (ACS) or heart failure (HF) found to have current depression...
What is the current status of trial NCT03118752?
This trial is currently completed. It is a NA study. The enrollment target is 290 participants. The study started on 2017-10-16. Estimated completion is 2024-03-08.
What conditions does trial NCT03118752 study?
This clinical trial studies the following conditions: Depression, Heart Failure, Generalized Anxiety Disorder, Acute Coronary Syndrome, Panic Disorder.
What interventions are being tested in trial NCT03118752?
The interventions under investigation include: Collaborative Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT03118752?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03118752 being conducted?
This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03118752's enrollment target sits among peer trials
290 154th of 679 higher than 525 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression 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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