Improving Outcomes for Individuals With Serious Mental Illness and Diabetes
TTIM
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus
Started Jul 2011
Longer than P75 for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 29, 2011
CompletedFirst Posted
Study publicly available on registry
August 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
October 4, 2017
CompletedOctober 4, 2017
October 1, 2017
4 years
July 29, 2011
April 18, 2017
October 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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
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
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Other Outcomes (7)
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
- +4 more other outcomes
Study Arms (2)
Targeted Training in Illness Management (TTIM)
EXPERIMENTALParticipants 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.
Treatment As Usual (TAU)
NO INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Have Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression
- Have DM based upon either previous diagnosis or laboratory values
- Be ≥ 18 years of age
- Be able to communicate in English
- Be able to provide written, informed consent to participation.
You may not qualify if:
- Actively suicidal/homicidal
- Unable to be rated on study rating scales
- Demented
- Pregnant
- Unable to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Case Western Reserve Universitylead
- National Institute of Mental Health (NIMH)collaborator
- MetroHealth Medical Centercollaborator
Study Sites (1)
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Related Publications (2)
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.
PMID: 30160510DERIVEDAftab 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.
PMID: 29280685DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Martha Sajatovic
- Organization
- Case Western Reserve University School of Medicine and Neurological Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Martha Sajatovic, MD
Case Western Reserve University
- PRINCIPAL INVESTIGATOR
Neal V Dawson, MD
Case Western Reserve University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
July 29, 2011
First Posted
August 5, 2011
Study Start
July 1, 2011
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
October 4, 2017
Results First Posted
October 4, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will share
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.