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NCT01676909 · ClinicalTrials.gov registry record · NA
Wellness Self-Management
A NA study of Mental Illness and Chronic Medical Illness, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 262
- Enrollment target
- 2
- Study locations
NCT01676909: Completed NA study of Mental Illness and Chronic Medical Illness, sponsored by VA Office of Research and Development.
NCT01676909 is a NA study of Mental Illness and Chronic Medical Illness that has completed, run by VA Office of Research and Development. The registered enrollment target is 262 participants, above the 171-participant average among 11 other Mental Illness trials with a reported enrollment target (53% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01676909, a NA study of Mental Illness and Chronic Medical Illness, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 262 participants
- Enrollment target
- 2
- Study locations
Study Summary
Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting in increased risk of disability, high health care spending, reduced quality of life and early mortality. Physical wellness is increasingly recognized as a key component of the VA's commitment to developing recovery-oriented and Veteran-centered mental health treatment. There is also growing recognition of the value of interventions that promote and improve patient self-management of chronic medical conditions. Building on the established efficacy of consumer facilitated medical illness self-management programming used in the general population and two recent adaptations for use with SMI adults in the public health sector (including the investigators' own evaluation of an intervention called Living Well), the investigators propose to complete a randomized controlled effectiveness trial of the Living Well intervention and simultaneously conduct a well specified process evaluation to optimize knowledge accrual regarding important factors that may improve future adoption, implementation and sustainability of the Living Well intervention in the VA system of care.
Primary Outcome
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious men
Conditions Studied
Interventions
- BEHAVIORAL Living Well
- BEHAVIORAL Medical Illness Education & Support Group
Study Locations (2)
District of Columbia
- Washington DC VA Medical Center, Washington, DC - Washington D.C.
Maryland
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2013-10-01 |
| Est. Completion | 2016-12-31 |
| Phase | NA |
What the finished NCT01676909 record still lists
NCT01676909 is an interventional study that assigns participants to a tested intervention. The registered 262 participants enrollment target is mid-sized for trials with a published cap, above the 171-participant average among 11 other Mental Illness trials with a reported enrollment target (53% higher).
The record links to 2 conditions, with Mental Illness appearing as the primary indexed condition, and to 2 interventions - of which Living Well is the first listed.
NCT01676909 reports a single indexed study location in District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT01676909 about?
NCT01676909 is a clinical study titled "Wellness Self-Management". Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting in increased risk of disability, high health care spending, reduced quality of life and early mortality. Physical we...
What is the current status of trial NCT01676909?
This trial is currently completed. It is a NA study. The enrollment target is 262 participants. The study started on 2013-10-01. Estimated completion is 2016-12-31.
What conditions does trial NCT01676909 study?
This clinical trial studies the following conditions: Mental Illness, Chronic Medical Illness.
What interventions are being tested in trial NCT01676909?
The interventions under investigation include: Living Well (BEHAVIORAL), Medical Illness Education & Support Group (BEHAVIORAL).
Who is sponsoring clinical trial NCT01676909?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01676909 being conducted?
This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01676909's enrollment target sits among peer trials
262 4th of 11 higher than 8 of 11 other Mental Illness trials
participants (enrollment target), bucketed by value
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