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NCT03118752
Pragmatic Collaborative Care for Cardiac Inpatients With Depression or Anxiety
NA trial testing Collaborative Care in Acute Coronary Syndrome in 290 participants. Completed in 8 March 2024.
8 March 2024
Quick facts
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 290 |
| Start date | 16 October 2017 |
| Primary completion | 8 March 2024 |
| Estimated completion | 8 March 2024 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Collaborative Care
Conditions studied
- Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →
- Heart Failure — all drugs for Heart Failure →
- Depression — all drugs for Depression →
- Generalized Anxiety Disorder — all drugs for Generalized Anxiety Disorder →
Sponsor
Massachusetts General Hospital
Who can join
18 and older, any sex, with Acute Coronary Syndrome or Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03118752
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT03523923 — TBI Care: Collaborative Care for Pain After Traumatic Brain Injury (TBI) · NA · completed
- NCT03199326 — Collaborative Care for Infants at Risk · NA · completed
Other recruiting trials for Acute Coronary Syndrome
Currently open trials in the same condition.
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- NCT07032389 — A Polypill for Acute Coronary Syndrome · Phase 2 · recruiting
- NCT07102628 — Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronar · Phase 3 · recruiting
- NCT06416813 — Preventive Intervention Value of DCB in Vulnerable Coronary Atherosclerotic Plaques · NA · active not recruiting
Other Massachusetts General Hospital trials
Trials by the same sponsor.
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- NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg · NA · not yet recruiting
- NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior · NA · not yet recruiting
- NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
- NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03118752 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
- Last refreshed: 13 May 2024
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing