NCT01410357|CompletedResultsDMC
Improving Outcomes for Individuals With Serious Mental Illness and Diabetes
TTIM
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Sponsor study identifier
NIH
Secondary identifiers
NIH
interventional
200
1 country
1
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2015
Actual (reported)Study Completion
July 2015
Actual (reported)This project tests a model for improving illness self-management among persons who have both serious mental illness and diabetes and will be performed within a primary care setting at a safety net hospital system. The information gained from the randomized trial will be supplemented with reports from participants about their experiences of trying to improve illness self-management. Improvements in self-management should result in a reduction of psychiatric symptoms and improvements in functioning and physical health.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
July 29, 2011
Actual (reported)August 5, 2011
Actual (reported)July 2015
Actual (reported)July 2015
Actual (reported)October 4, 2017
Actual (reported)Brief Psychiatric Rating Scale (BPRS) at 60 Weeks
The BPRS measures psychotic and non-psychotic symptoms in serious mental illness. Possible total scores range from 7 to 126, with higher scores indicating greater symptom severity. For this study, the BPRS with 18 items was used. Each symptom measured ranges from 1-7, and all 18 items/symptoms are summed to create the total score. Only the BPRS total score was utilized in the analyses.
60 weeks
Montgomery Asberg Depression Rating Scale (MADRS) at 60 Weeks
The MADRS is a 10-item depression severity scale widely utilized in studies with patients with serious mental illness. Possible scores range from 0 to 60 with higher scores indicating worse depression.
60 weeks
Clinical Global Impression (CGI) at 60 Weeks
Participants in this arm will receive the TTIM intervention as well as receiving regular treatment for their DM and SMI from their normal medical and mental health care providers.
Participants in this arm will continue to receive Treatment as Usual from their usual medical and mental health care providers. They will not receive any intervention.
This intervention blends psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, has been adapted to the primary care setting and targeted for SMI-DM participants. Generalizability is enhanced with relatively brief in-person participation requirements and by utilizing professional staff typically found in primary care. TTIM will stress information sharing that is accessible to participants, and through a collaborative process, foster motivation for SMI-DM self-management.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Sajatovic M, Howland M, Gunzler D, Kanuch SW, Cassidy KA, McCormick R, Bauer MS, Scheidemantel T, Thomas C, Blixen C, Dawson NV. Race analysis in an African American sample with serious mental illness and comorbid diabetes. Psychiatr Rehabil J. 2018 Sep;41(3):246-252. doi: 10.1037/prj0000314.
Aftab A, Bhat C, Gunzler D, Cassidy K, Thomas C, McCormick R, Dawson NV, Sajatovic M. Associations among comorbid anxiety, psychiatric symptomatology, and diabetic control in a population with serious mental illness and diabetes: Findings from an interventional randomized controlled trial. Int J Psychiatry Med. 2018 May;53(3):126-140. doi: 10.1177/0091217417749795. Epub 2017 Dec 27.
Martha Sajatovic, MD
Case Western Reserve University
Neal V Dawson, MD
Case Western Reserve University
200 participants (actual enrollment reported by the registry).
First Submitted
July 29, 2011
First Posted
August 5, 2011
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Self-Management Training and Automated Telehealth to Improve SMI Health Outcomes
The Clinical Global Impression (CGI) is a broad measure of global psychopathology that evaluates illness severity on a 1 to 7 point continuum. Possible scores range from 0 to 7, with higher scores indicating greater psychopathology.
60 weeks
Global Assessment of Functioning (GAF) at 60 Weeks
The GAF is a 100-point single-item scale that measures global functioning. Possible scores range from 1 to 100, with higher scores indicating better functioning.
60 weeks
Sheehan Disability Scale (SDS) at 60 Weeks
The SDS measures role impairment in three domains (work/school; family life/home; social life). Possible total scores range from 0 to 30, with higher scores indicating greater disability. Only the total score was reported in our analyses, and is denoted here. The total score is calculated by summing the three domain scores, each which range from 0-10.
60 weeks
SF-36 (Short-form) Health Survey at 60 Weeks; Mental Health Component
The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function.
60 weeks
Glycosylated Hemoglobin (HbA1c) at 60 Weeks
60 weeks
Systolic Blood Pressure at 60 Weeks
60 weeks
Body Mass Index (BMI) at 60 Weeks
60 weeks
SF-36 Health Survey at 60 Weeks; Physical Health Component
The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function.
60 weeks
Tablets Routine Questionnaire (TRQ) at 60 Weeks
60 weeks
Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 60 Weeks
60 weeks
Comparison of AUDIT (Alcohol Use Disorders Identification Test) Score Between TTIM and TAU (Treatment as Usual) at 60 Weeks
60 weeks
Comparison of ISMI (Internalized Stigma of Mental Illness -Alienation) Between TTIM and TAU at 60 Weeks
60 weeks
Comparison of ISMI (Stereotype Endorsement) Score Between TTIM and TAU at 60 Weeks
60 weeks
Comparison of Utilization (Phys Ed) Score Between TTIM and TAU at 60 Weeks
60 weeks
Comparison of Utilization (Mental Ed) Score Between TTIM and TAU at 60 Weeks
60 weeks
Comparison of Utilization (Mental Hospital) Score Between TTIM and TAU at 60 Weeks
60 weeks
Contact the study team to confirm eligibility.
Primary Completion
July 2015
Actual (reported)Study Completion
July 2015
Actual (reported)Last Updated
October 4, 2017
Results First Posted
October 4, 2017
Record last verified: 2017-10
The investigators will make deidentified data available to other qualified investigators in the research community. Data will remain under control of the PIs of the research study at CWRU. Copies of electronic data files accompanied by data documentation (metadata) will be shared. Qualified investigators may contact the PIs for information on how to request data. Investigators will be required (at minimum) to provide 1) the names and qualifications of all individuals who will have any access to primary data files; 2) a research proposal detailing how the data will be used; 3) a statement that the investigators will a) not further share the primary data with third parties, b) protect the privacy of subjects, c) provide a means to protect the confidentiality of the data; and 4) a data transfer/use agreement with CWRU. Only data necessary to meet the goals of the investigators' research proposal will be provided to limit the risk of identifying individual research subjects.
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Source: ClinicalTrials.gov.
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