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NCT02059005 · ClinicalTrials.gov registry record · NA
Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions
A NA study of Diabetes Mellitus and End Stage Renal Disease, sponsored by Treatment Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 97
- Enrollment target
- 1
- Study location
NCT02059005 is a NA study of Diabetes Mellitus and End Stage Renal Disease that has completed, run by Treatment Research Institute. The registered enrollment target is 97 participants, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02059005, a NA study of Diabetes Mellitus and End Stage Renal Disease, has completed, sponsored by Treatment Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 97 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will assess Specialized Community Disease Management (SCDM), an intervention which employs various evidence-based strategies to engage substance using co-morbid patients while in the hospital and follow them into the community via an empirically validated telephone approach as well as contact with a trained community health worker peer specialist. The investigators will first adapt and refine the core SCDM intervention with patient, provider, and stakeholder input through an active community advisory board. The investigators will then conduct a three-year, randomized controlled trial of 222 patients enrolled prior to hospital discharge who are diagnosed with congestive heart failure, pneumonia, acute myocardial infarction, chronic obstructive pulmonary disease, diabetes mellitus, or end-stage renal disease, and a substance use disorder (SUD). Patients will be randomized to either the SCDM intervention or Treatment as Usual (TAU), in which a team of nurse navigators and community health workers follow patients (primarily by telephone) for 90 days post-discharge, but do not address the specific needs of SUDs. The investigators will test the following four hypotheses: (1) patients randomized to SCDM will demonstrate larger reductions in substance use measured by urine-confirmed self-reported days using over the 6-month follow-up compared to patients randomized to TAU, (2) patients randomized to SCDM will attend more specialty substance abuse intervention and treatment sessions over the 6 month follow-up than patients randomized to TAU, (3) patients randomized to SCDM will demonstrate reduced HIV transmission risk behaviors and greater rates of HIV testing over the 6 month follow-up than patients randomized to TAU, and (4) patients randomized to SCDM will experience fewer days of rehospitalization and use of acute emergency services than patients randomized to TAU.
Conditions Studied
Interventions
- BEHAVIORAL Treatment As Usual
- BEHAVIORAL Specialized Community Disease Management
Study Locations (1)
Pennsylvania
- Temple University Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2014-11-18 |
| Est. Completion | 2017-02-28 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02059005
The ClinicalTrials.gov registry entry for NCT02059005 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (95% lower). The listed sponsor is Treatment Research Institute, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Treatment As Usual is the first listed.
NCT02059005 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02059005 about?
NCT02059005 is a clinical study titled "Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions". This study will assess Specialized Community Disease Management (SCDM), an intervention which employs various evidence-based strategies to engage substance using co-morbid patients while in the hospital and follow them into the community via an empirically validated telephone approach as well as con...
What is the current status of trial NCT02059005?
This trial is currently completed. It is a NA study. The enrollment target is 97 participants. The study started on 2014-11-18. Estimated completion is 2017-02-28.
What conditions does trial NCT02059005 study?
This clinical trial studies the following conditions: Diabetes Mellitus, End Stage Renal Disease, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, Pneumonia.
What interventions are being tested in trial NCT02059005?
The interventions under investigation include: Treatment As Usual (BEHAVIORAL), Specialized Community Disease Management (BEHAVIORAL).
Who is sponsoring clinical trial NCT02059005?
This trial is sponsored by Treatment Research Institute, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02059005 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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