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Improving Outcomes for Individuals With Serious Mental Illness and Diabetes (TTIM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01410357
First Posted: August 5, 2011
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Mental Health (NIMH)
MetroHealth Medical Center
Information provided by (Responsible Party):
Martha Sajatovic, MD, Case Western Reserve University
July 29, 2011
August 5, 2011
April 18, 2017
October 4, 2017
October 4, 2017
July 2011
July 2015   (Final data collection date for primary outcome measure)
  • Brief Psychiatric Rating Scale (BPRS) at 60 Weeks [ Time Frame: 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.
  • Montgomery Asberg Depression Rating Scale (MADRS) at 60 Weeks [ Time Frame: 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.
  • Clinical Global Impression (CGI) at 60 Weeks [ Time Frame: 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.
  • Global Assessment of Functioning (GAF) at 60 Weeks [ Time Frame: 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.
  • Sheehan Disability Scale (SDS) at 60 Weeks [ Time Frame: 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.
  • SF-36 (Short-form) Health Survey at 60 Weeks; Mental Health Component [ Time Frame: 60 weeks ]
    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.
  • Glycosylated Hemoglobin (HbA1c) at 60 Weeks [ Time Frame: 60 weeks ]
  • Systolic Blood Pressure at 60 Weeks [ Time Frame: 60 weeks ]
  • Body Mass Index (BMI) at 60 Weeks [ Time Frame: 60 weeks ]
  • SF-36 Health Survey at 60 Weeks; Physical Health Component [ Time Frame: 60 weeks ]
    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.
  • Change from Baseline in Brief Psychiatric Rating Scale (BPRS) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ]
  • Change from Baseline in Montgomery Asburg Depression Rating Scale (MADRS) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ]
  • Change from Baseline in Clinical Global Impression (CGI) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ]
  • Change from Baseline in Global Assessment of Functioning (GAF) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ]
  • Change from Baseline in Sheehan Disability Scale (SDS) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ]
  • Change from Baseline in SF-12 Health Survey at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ]
  • Change from Baseline in Glycosylated Hemoglobin (HbA1c) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ]
  • Change from Baseline in Blood Pressure at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ]
  • Change from Baseline in Body Mass Index (BMI) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ]
Complete list of historical versions of study NCT01410357 on ClinicalTrials.gov Archive Site
  • Tablets Routine Questionnaire (TRQ) at 60 Weeks [ Time Frame: 60 weeks ]
    The self-reported Tablets Routine Questionnaire (TRQ) measures change in treatment adherence. The TRQ determines proportion of prescribed medication missed, and ranges from 0 (no medication missed/100% adherent) to 100 (no medication taken/0% adherent). The TRQ format captured an exact proportion (%) of days with a missed medication dose for each oral maintenance psychotropic medication and then an average combined TRQ was calculated for all orally-prescribed medications.
  • Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 60 Weeks [ Time Frame: 60 weeks ]
    The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking. It is comprised of 10 questions, to which each have a 5 point scale with anchors 1= never through 5= always. The items are summed to a total score, which ranges from 10-50.
  • Comparison of AUDIT (Alcohol Use Disorders Identification Test) Score Between TTIM and TAU (Treatment as Usual) at 60 Weeks [ Time Frame: 60 weeks ]
    The AUDIT scale (Alcohol Use Disorders Identification Test) has 10 questions, with scores on each question ranging from 0 to 4 (0= never, 1= less than monthly, 2= monthly, 3= weekly 4= daily/almost daily). Questions 9 and 10 only have three anchors: 0, 2, and 4. The scores are summed to get total. Therefore, the range of possible scores are 0-40, with higher scores indicating indicating a greater likelihood of hazardous and harmful drinking. However, such scores may also reflect greater severity of alcohol problems and dependence, as well as a greater need for more intensive treatment.
  • Comparison of ISMI (Internalized Stigma of Mental Illness -Alienation) Between TTIM and TAU at 60 Weeks [ Time Frame: 60 weeks ]
    The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Alienation, has 6 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Alienation subscale range from 6-30, with higher scores reflecting higher levels of reported internalized stigma of mental illness.
  • Comparison of ISMI (Stereotype Endorsement) Score Between TTIM and TAU at 60 Weeks [ Time Frame: 60 weeks ]
    The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Stereotype Endorsement, has 7 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= agree, 4= strongly agree. Total scores on the Stereotype Endorsement subscale range from 7-28, with higher scores reflecting higher levels of reported internalized stigma of mental illness.
  • Comparison of ISMI (Discrimination Experience) Between TTIM and TAU at 60 Weeks [ Time Frame: 60 weeks ]
    The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Discrimination Experience, has 5 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Discrimination Experience subscale range from 5-25, with higher scores reflecting higher levels of reported internalized stigma of mental illness.
  • Comparison of ISMI (Social Withdrawal) Score Between TTIM and TAU at 60 Weeks [ Time Frame: 60 weeks ]
    The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Social Withdrawal, has 6 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Social Withdrawal subscale range from 6-30, with higher scores reflecting higher levels of reported internalized stigma of mental illness.
  • Comparison of ISMI (Stigma Resistance) Score Between TTIM and TAU at 60 Weeks [ Time Frame: 60 weeks ]
    The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Stigma Resistance, has 5 Likert-scale items. Each question is rated as 0= strongly disagree, 1= disagree, 2= neutral, 3= agree, 4= strongly agree. These scores are all reverse coded. Total scores on the Stigma Resistance subscale range from 0-20, with higher scores reflecting higher levels of reported internalized stigma of mental illness.
  • Change from Baseline in Tablets Routine Questionnaire (TRQ) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ]
  • Change from Baseline in Addiction Severity Index (ASI) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ]
    substance abuse portion only
  • Change from Baseline in Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ]
  • Comparison of Utilization (Phys Ed) Score Between TTIM and TAU at 60 Weeks [ Time Frame: 60 weeks ]
    The Utilization of Physical Education score looks at how many times a participant used these resources. Analyses include a simple mean and SD.
  • Comparison of Utilization (Mental Ed) Score Between TTIM and TAU at 60 Weeks [ Time Frame: 60 weeks ]
    The Utilization of Mental Education score looks at how many times a participant used these resources. Analyses include a simple mean and SD.
  • Comparison of Utilization (Mental Hospital) Score Between TTIM and TAU at 60 Weeks [ Time Frame: 60 weeks ]
    The Utilization of Mental Hospital score looks at how many times a participant used these resources. Analyses include a simple mean and SD.
  • Comparison of Diabetes Knowledge Score Between TTIM and TAU at 60 Weeks [ Time Frame: 60 weeks ]
    The diabetes knowledge score has 23 questions which assess how much knowledge one has about diabetes. They are in multiple choice format, with 4 choices, and only one is correct. The total amount correct is added up, and then calculated into a percentage of answers correct.
  • Comparison of MSPSS (Multidimensional Scale of Perceived Social Support) Score Between TTIM and TAU at 60 Weeks [ Time Frame: 60 weeks ]
    The Multidimensional Scale of Perceived Social Support is a 12 question Likert scale, with each item ranging from 1-5. Total scores range from 12-60, with higher scores indicating more perceived social support.
  • Comparison of PDSMS (Perceived Diabetes Self Management Scale)Score Between TTIM and TAU at 60 Weeks [ Time Frame: 60 weeks ]
    The Perceived Diabetes Self-Management Scale is an 8-item Likert scale, with each question ranging from 1-5. Items 1, 2, 6, and 7 are reverse coded. Total summed scores range from 8-40, with higher scores indicating higher perceived self-management competence in regards to diabetes.
  • Comparison of PMHSMS (Perceived Mental Health Self-Management Scale) Score Between TTIM and TAU at 60 Weeks [ Time Frame: 60 weeks ]
    The Perceived Mental Health Self-Management Scale is an 8-item Likert scale, with each question ranging from 1-5. Total summed scores range from 8-40, with higher scores indicating higher perceived self-management competence in regards to mental health.
Not Provided
 
Improving Outcomes for Individuals With Serious Mental Illness and Diabetes
Improving Outcomes for Individuals With Serious Mental Illness and Diabetes
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.

This project will test a novel intervention, Targeted Training in Illness Management (TTIM), intended to improve both serious mental illness (SMI) and diabetes mellitus (DM) self-management in 100 individuals with SMI-DM vs. 100 individuals with SMI-DM receiving treatment as usual (TAU). The intervention will be conducted in a safety-net health system primary care setting and will be conducted as a randomized controlled trial (RCT). The primary effects of TTIM will be assessed with respect to SMI symptoms, Functional Status/Role Impairment, General Health Status, and DM outcomes. Secondary outcomes include adherence to psychotropic and DM medication, and engagement in healthy behaviors.

This assessment will include quantitative assessment of facilitators/barriers targeted by the proposed intervention as well as a supplemental qualitative assessment. The qualitative assessments will include input from patients and interventionists. Specific aims for the qualitative analysis are to validate findings from the RCT, expand understanding of "key active ingredients" of TTIM, and provide information to inform future studies on individuals with SMI and related medical conditions.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Diabetes Mellitus
  • Bipolar Disorder
  • Depression
  • Psychotic Disorders
  • Schizophrenia
Behavioral: Targeted Training in Illness Management (TTIM)
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.
  • Experimental: Targeted Training in Illness Management (TTIM)
    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.
    Intervention: Behavioral: Targeted Training in Illness Management (TTIM)
  • No Intervention: Treatment As Usual (TAU)
    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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
July 2015
July 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Have Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression
  2. Have DM based upon either previous diagnosis or laboratory values
  3. Be ≥ 18 years of age
  4. Be able to communicate in English
  5. Be able to provide written, informed consent to participation.

Exclusion Criteria:

  1. Actively suicidal/homicidal
  2. Unable to be rated on study rating scales
  3. Demented
  4. Pregnant
  5. Unable to provide informed consent.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01410357
R01MH085665( U.S. NIH Grant/Contract )
R01MH085665 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description:

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.

Martha Sajatovic, MD, Case Western Reserve University
Case Western Reserve University
  • National Institute of Mental Health (NIMH)
  • MetroHealth Medical Center
Principal Investigator: Martha Sajatovic, MD Case Western Reserve University
Principal Investigator: Neal V Dawson, MD Case Western Reserve University
Case Western Reserve University
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP