A Self-Management Program for Adults With Both Schizophrenia and a Co-occurring Medical Condition
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-management program for chronic illness
Sponsored by

About this trial
This is an interventional supportive care trial for Schizophrenia focused on measuring medical co-morbidity, diabetes, heart disease, respiratory illness
Eligibility Criteria
Inclusion Criteria:
- Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
- Current documented chart diagnosis of at least one chronic medical condition
- Received clinic services for a minimum of 3 months prior to study entry
- English-speaking
- Willing to use an effective form of birth control throughout the study if sexually active
Exclusion Criteria:
- History of a serious neurological disorder or head trauma with loss of consciousness
- Diagnosed with mental retardation or dementia
- Diagnosed with end stage organ disease
- Currently receiving chemotherapy and/or radiation treatment for cancer
- Received psychiatric hospitalization less than 3 months prior to study entry date
- Blind and/or deaf
- Pregnant
- Infected with HIV with a CD4 count under 350
- Diagnosis of AIDS
- Diagnosis of anorexia
- Problematic substance use, as defined by a mental health provider
- Psychiatric instability, as defined by a mental health provider
Sites / Locations
- Fayette Street Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
Usaual Care
Arm Description
Participants will receive a self-management program for chronic illness
Usual Care; no additional intervention
Outcomes
Primary Outcome Measures
Health-related self-efficacy and recovery orientation
Medical illness self-management skills
Social and communication skills during interactions with health care providers
Physical and mental health status
Medical service use patterns
Secondary Outcome Measures
Medication use
Neurocognition
Substance abuse
Psychiatric symptoms
Amount and seriousness of related comorbidities
Quantitative and qualitative survey ratings
Full Information
NCT ID
NCT00525304
First Posted
September 4, 2007
Last Updated
August 23, 2019
Sponsor
University of Maryland, Baltimore
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00525304
Brief Title
A Self-Management Program for Adults With Both Schizophrenia and a Co-occurring Medical Condition
Official Title
Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will develop and evaluate the effectiveness of a self-management program for adults living with both schizophrenia and a co-occurring medical condition.
Detailed Description
Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, and believe that others are controlling their thoughts. People with schizophrenia also experience increased rates of concurrent medical conditions, such as diabetes, respiratory illness, and heart disease. This can make holding a job or even caring for oneself very difficult. The purpose of this study is to develop and evaluate a self-management program for adults living with both schizophrenia and a concurrent medical condition.
Participants in this open-label study will attend 10 to 16 group sessions led by two group leaders. Group sessions will meet each week for an hour during which participants will learn new skills to help them take responsibility for the daily management of chronic medical conditions. In addition to learning how to communicate more effectively with medical providers, participants will learn about healthy eating, the importance of physical activity, addictive behaviors that can worsen health conditions, and proper use of medications. Homework will be assigned weekly for participants to review skills learned in each session. After each session, participants will complete a survey to evaluate the session's effectiveness. At the end of the study, participants will attend one additional group meeting and an individual interview to discuss the overall effectiveness of the intervention and their experiences in the group sessions. The results of this study will be used to evaluate and improve the self-management program for future use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
medical co-morbidity, diabetes, heart disease, respiratory illness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive a self-management program for chronic illness
Arm Title
Usaual Care
Arm Type
No Intervention
Arm Description
Usual Care; no additional intervention
Intervention Type
Behavioral
Intervention Name(s)
Self-management program for chronic illness
Intervention Description
Self-management program for chronic illness will include between 10 and 16 psychoeducational and supportive group sessions.
Primary Outcome Measure Information:
Title
Health-related self-efficacy and recovery orientation
Time Frame
Measured at pre- and post-intervention
Title
Medical illness self-management skills
Time Frame
Measured at pre- and post-intervention
Title
Social and communication skills during interactions with health care providers
Time Frame
Measured at pre- and post-intervention
Title
Physical and mental health status
Time Frame
Measured at pre- and post-intervention
Title
Medical service use patterns
Time Frame
Measured at pre- and post-intervention
Secondary Outcome Measure Information:
Title
Medication use
Time Frame
Measured throughout the study
Title
Neurocognition
Time Frame
Measured at baseline
Title
Substance abuse
Time Frame
Measured at pre- and post-intervention
Title
Psychiatric symptoms
Time Frame
Measured at pre- and post-intervention
Title
Amount and seriousness of related comorbidities
Time Frame
Measured at pre- and post-intervention
Title
Quantitative and qualitative survey ratings
Time Frame
Measured throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
Current documented chart diagnosis of at least one chronic medical condition
Received clinic services for a minimum of 3 months prior to study entry
English-speaking
Willing to use an effective form of birth control throughout the study if sexually active
Exclusion Criteria:
History of a serious neurological disorder or head trauma with loss of consciousness
Diagnosed with mental retardation or dementia
Diagnosed with end stage organ disease
Currently receiving chemotherapy and/or radiation treatment for cancer
Received psychiatric hospitalization less than 3 months prior to study entry date
Blind and/or deaf
Pregnant
Infected with HIV with a CD4 count under 350
Diagnosis of AIDS
Diagnosis of anorexia
Problematic substance use, as defined by a mental health provider
Psychiatric instability, as defined by a mental health provider
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard W. Goldberg, PhD
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fayette Street Clinics
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
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A Self-Management Program for Adults With Both Schizophrenia and a Co-occurring Medical Condition
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