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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
Results First Submitted: April 18, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Diabetes Mellitus
Bipolar Disorder
Depression
Psychotic Disorders
Schizophrenia
Intervention: Behavioral: Targeted Training in Illness Management (TTIM)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Targeted Training in Illness Management (TTIM)

Participants in this arm received the TTIM intervention as well as regular treatment for their DM (diabetes mellitus) and SMI (serious mental illness) from their normal medical and mental health care providers.

Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management.

Treatment As Usual (TAU) Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.

Participant Flow:   Overall Study
    Targeted Training in Illness Management (TTIM)   Treatment As Usual (TAU)
STARTED   100   100 
COMPLETED   74   76 
NOT COMPLETED   26   24 
Death                2                1 
Withdrawal by Subject                1                2 
Lost to Follow-up                23                21 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Targeted Training in Illness Management (TTIM)

Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.

Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management.

Treatment As Usual (TAU) Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Total Total of all reporting groups

Baseline Measures
   Targeted Training in Illness Management (TTIM)   Treatment As Usual (TAU)   Total 
Overall Participants Analyzed 
[Units: Participants]
 100   100   200 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.8  (9.7)   52.6  (9.7)   52.7  (9.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      63  63.0%      65  65.0%      128  64.0% 
Male      37  37.0%      35  35.0%      72  36.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Caucasian   38   36   74 
African-American   52   55   107 
Other   10   9   19 
Hispanic   10   7   17 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   100   100   200 
Education 
[Units: Years]
Mean (Standard Deviation)
 12.7  (2.5)   12.5  (2.9)   12.6  (2.7) 
Health Insurance Type 
[Units: Participants]
Count of Participants
     
Private      5   5.0%      2   2.0%      7   3.5% 
Medicare      35  35.0%      34  34.0%      69  34.5% 
Medicaid      48  48.0%      47  47.0%      95  47.5% 
Other/None      12  12.0%      17  17.0%      29  14.5% 
Mini-International Neuropsychiatric Interview (MINI) 
[Units: Participants]
Count of Participants
     
Schizophrenia      29  29.0%      20  20.0%      49  24.5% 
Bipolar Disorder      22  22.0%      34  34.0%      56  28.0% 
Major Depressive Disorder      49  49.0%      46  46.0%      95  47.5% 
Serious Mental Illness duration 
[Units: Years]
Mean (Standard Deviation)
 19.1  (12.9)   17.8  (12.4)   18.5  (12.6) 
Diabetes mellitus duration 
[Units: Years]
Mean (Standard Deviation)
 9.8  (7.5)   10.3  (8.1)   10.1  (7.8) 
AHA-defined hypertension 
[Units: Participants]
Count of Participants
 45   42   87 
On second generation antipsychotic medication 
[Units: Participants]
Count of Participants
 40   33   73 
Insulin user 
[Units: Participants]
Count of Participants
 43   45   88 
Charlson Index [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 2.4  (1.7)   2.1  (1.5)   2.2  (1.6) 
[1] The self-reported Charlson Index evaluates medical comorbidity. Possible scores range from 0 to 9, with higher scores indicating higher comorbidity. There are no subscales for this measure, just a total score that is summed.
Basic Health Literacy Screen [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 12.5  (3.0)   12.4  (3.3)   12.5  (3.2) 
[1] The Basic Health Literacy Scale is comprised of three items on a 5-point response scale, ranging from 1-5. After reverse-scoring the item addressing confidence with forms (item #2), responses to the three items are summed. Total scores range between 3 and 15, with higher scores indicating higher subjective health literacy.
Clinical Global Impression [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 4.3  (1.0)   4.3  (0.9)   4.3  (0.9) 
[1] 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.
Montgomery Asberg Depression Rating Scale [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 23.1  (9.4)   25.0  (8.8)   24.1  (9.1) 
[1] 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.
Brief Psychiatry Rating Scale [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 38.7  (9.8)   41.3  (8.9)   40.0  (9.3) 
[1] 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.
Global Assessment of Functioning [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 51.8  (11.0)   51.4  (11.9)   51.6  (11.5) 
[1] 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 [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 18.0  (5.8)   17.8  (6.5)   17.9  (6.2) 
[1] 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.
Short-form 36 (general health status) [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
     
Physical   39.4  (10.1)   39.8  (10.9)   39.6  (10.5) 
Mental   37.2  (10.6)   35.6  (12.1)   36.4  (11.4) 
[1] 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. Both the physical and mental are separate subscales with their own scoring as determined by the process above.
Glycosylated hemoglobin (HbA1c) 
[Units: Mmol/mol]
Mean (Standard Deviation)
 8.2  (2.0)   8.0  (2.4)   8.2  (2.3) 
Systolic blood pressure 
[Units: mmHg]
Mean (Standard Deviation)
 135.0  (20.7)   134.5  (21.7)   134.8  (21.2) 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 35.4  (8.0)   36.6  (9.4)   36.0  (8.7) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Brief Psychiatric Rating Scale (BPRS) at 60 Weeks   [ Time Frame: 60 weeks ]

2.  Primary:   Montgomery Asberg Depression Rating Scale (MADRS) at 60 Weeks   [ Time Frame: 60 weeks ]

3.  Primary:   Clinical Global Impression (CGI) at 60 Weeks   [ Time Frame: 60 weeks ]

4.  Primary:   Global Assessment of Functioning (GAF) at 60 Weeks   [ Time Frame: 60 weeks ]

5.  Primary:   Sheehan Disability Scale (SDS) at 60 Weeks   [ Time Frame: 60 weeks ]

6.  Primary:   SF-36 (Short-form) Health Survey at 60 Weeks; Mental Health Component   [ Time Frame: 60 weeks ]

7.  Primary:   Glycosylated Hemoglobin (HbA1c) at 60 Weeks   [ Time Frame: 60 weeks ]

8.  Primary:   Systolic Blood Pressure at 60 Weeks   [ Time Frame: 60 weeks ]

9.  Primary:   Body Mass Index (BMI) at 60 Weeks   [ Time Frame: 60 weeks ]

10.  Primary:   SF-36 Health Survey at 60 Weeks; Physical Health Component   [ Time Frame: 60 weeks ]

11.  Secondary:   Tablets Routine Questionnaire (TRQ) at 60 Weeks   [ Time Frame: 60 weeks ]

12.  Secondary:   Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 60 Weeks   [ Time Frame: 60 weeks ]

13.  Secondary:   Comparison of AUDIT (Alcohol Use Disorders Identification Test) Score Between TTIM and TAU (Treatment as Usual) at 60 Weeks   [ Time Frame: 60 weeks ]

14.  Secondary:   Comparison of ISMI (Internalized Stigma of Mental Illness -Alienation) Between TTIM and TAU at 60 Weeks   [ Time Frame: 60 weeks ]

15.  Secondary:   Comparison of ISMI (Stereotype Endorsement) Score Between TTIM and TAU at 60 Weeks   [ Time Frame: 60 weeks ]

16.  Secondary:   Comparison of ISMI (Discrimination Experience) Between TTIM and TAU at 60 Weeks   [ Time Frame: 60 weeks ]

17.  Secondary:   Comparison of ISMI (Social Withdrawal) Score Between TTIM and TAU at 60 Weeks   [ Time Frame: 60 weeks ]

18.  Secondary:   Comparison of ISMI (Stigma Resistance) Score Between TTIM and TAU at 60 Weeks   [ Time Frame: 60 weeks ]

19.  Other Pre-specified:   Comparison of Utilization (Phys Ed) Score Between TTIM and TAU at 60 Weeks   [ Time Frame: 60 weeks ]

20.  Other Pre-specified:   Comparison of Utilization (Mental Ed) Score Between TTIM and TAU at 60 Weeks   [ Time Frame: 60 weeks ]

21.  Other Pre-specified:   Comparison of Utilization (Mental Hospital) Score Between TTIM and TAU at 60 Weeks   [ Time Frame: 60 weeks ]

22.  Other Pre-specified:   Comparison of Diabetes Knowledge Score Between TTIM and TAU at 60 Weeks   [ Time Frame: 60 weeks ]

23.  Other Pre-specified:   Comparison of MSPSS (Multidimensional Scale of Perceived Social Support) Score Between TTIM and TAU at 60 Weeks   [ Time Frame: 60 weeks ]

24.  Other Pre-specified:   Comparison of PDSMS (Perceived Diabetes Self Management Scale)Score Between TTIM and TAU at 60 Weeks   [ Time Frame: 60 weeks ]

25.  Other Pre-specified:   Comparison of PMHSMS (Perceived Mental Health Self-Management Scale) Score Between TTIM and TAU at 60 Weeks   [ Time Frame: 60 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Martha Sajatovic
Organization: Case Western Reserve University School of Medicine and Neurological Institute
phone: 216-844-2808
e-mail: martha.sajatovic@uhhospitals.org



Responsible Party: Martha Sajatovic, MD, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01410357     History of Changes
Other Study ID Numbers: R01MH085665 ( U.S. NIH Grant/Contract )
First Submitted: July 29, 2011
First Posted: August 5, 2011
Results First Submitted: April 18, 2017
Results First Posted: October 4, 2017
Last Update Posted: October 4, 2017