Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-25 @ 6:34 PM
Study NCT ID:
NCT00525304
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2007-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Self-Management Program for Adults With Both Schizophrenia and a Co-occurring Medical Condition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073278', 'term': 'Self-Management'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-23', 'studyFirstSubmitDate': '2007-09-04', 'studyFirstSubmitQcDate': '2007-09-04', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related self-efficacy and recovery orientation', 'timeFrame': 'Measured at pre- and post-intervention'}, {'measure': 'Medical illness self-management skills', 'timeFrame': 'Measured at pre- and post-intervention'}, {'measure': 'Social and communication skills during interactions with health care providers', 'timeFrame': 'Measured at pre- and post-intervention'}, {'measure': 'Physical and mental health status', 'timeFrame': 'Measured at pre- and post-intervention'}, {'measure': 'Medical service use patterns', 'timeFrame': 'Measured at pre- and post-intervention'}], 'secondaryOutcomes': [{'measure': 'Medication use', 'timeFrame': 'Measured throughout the study'}, {'measure': 'Neurocognition', 'timeFrame': 'Measured at baseline'}, {'measure': 'Substance abuse', 'timeFrame': 'Measured at pre- and post-intervention'}, {'measure': 'Psychiatric symptoms', 'timeFrame': 'Measured at pre- and post-intervention'}, {'measure': 'Amount and seriousness of related comorbidities', 'timeFrame': 'Measured at pre- and post-intervention'}, {'measure': 'Quantitative and qualitative survey ratings', 'timeFrame': 'Measured throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['medical co-morbidity', 'diabetes', 'heart disease', 'respiratory illness'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nParticipants 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets DSM-IV criteria for schizophrenia or schizoaffective disorder\n* Current documented chart diagnosis of at least one chronic medical condition\n* Received clinic services for a minimum of 3 months prior to study entry\n* English-speaking\n* Willing to use an effective form of birth control throughout the study if sexually active\n\nExclusion Criteria:\n\n* History of a serious neurological disorder or head trauma with loss of consciousness\n* Diagnosed with mental retardation or dementia\n* Diagnosed with end stage organ disease\n* Currently receiving chemotherapy and/or radiation treatment for cancer\n* Received psychiatric hospitalization less than 3 months prior to study entry date\n* Blind and/or deaf\n* Pregnant\n* Infected with HIV with a CD4 count under 350\n* Diagnosis of AIDS\n* Diagnosis of anorexia\n* Problematic substance use, as defined by a mental health provider\n* Psychiatric instability, as defined by a mental health provider'}, 'identificationModule': {'nctId': 'NCT00525304', 'briefTitle': 'A Self-Management Program for Adults With Both Schizophrenia and a Co-occurring Medical Condition', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia', 'orgStudyIdInfo': {'id': 'HP-00040526'}, 'secondaryIdInfos': [{'id': 'R34MH078168', 'link': 'https://reporter.nih.gov/quickSearch/R34MH078168', 'type': 'NIH'}, {'id': 'DAHBR 96-BHB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participants will receive a self-management program for chronic illness', 'interventionNames': ['Behavioral: Self-management program for chronic illness']}, {'type': 'NO_INTERVENTION', 'label': 'Usaual Care', 'description': 'Usual Care; no additional intervention'}], 'interventions': [{'name': 'Self-management program for chronic illness', 'type': 'BEHAVIORAL', 'description': 'Self-management program for chronic illness will include between 10 and 16 psychoeducational and supportive group sessions.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Fayette Street Clinics', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Richard W. Goldberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, College Park'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Richard Goldberg', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}