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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
MetroHealth Medical Center
Information provided by (Responsible Party):
Martha Sajatovic, MD, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01410357
First received: July 29, 2011
Last updated: March 31, 2014
Last verified: March 2014

July 29, 2011
March 31, 2014
July 2011
July 2015   (final data collection date for primary outcome measure)
  • Change from Baseline in Brief Psychiatric Rating Scale (BPRS) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Montgomery Asberg Depression Rating Scale (MADRS) at 13 weeks, 30 weeks, and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Clinical Global Impression (CGI) at 13 weeks, 30 weeks, and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Global Assessment of Functioning (GAF) at 13 weeks, 30 weeks, and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Sheehan Disability Scale (SDS) at 13 weeks, 30 weeks, and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in SF-36 Health Survey at 13 weeks, 30 weeks, and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Glycosylated Hemoglobin (HbA1c) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Blood Pressure at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Body Mass Index (BMI) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Heart Rate at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Brief Psychiatric Rating Scale (BPRS) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Montgomery Asburg Depression Rating Scale (MADRS) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Clinical Global Impression (CGI) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Global Assessment of Functioning (GAF) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Sheehan Disability Scale (SDS) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Glycosylated Hemoglobin (HbA1c) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Blood Pressure at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Body Mass Index (BMI) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in SF-12 Health Survey at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01410357 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Tablets Routine Questionnaire (TRQ) at 13 weeks, 30 weeks, and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 13 weeks, 30 weeks, and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in The Alcohol Use Disorders Identification Test (AUDIT) at 13 weeks, 30 weeks, and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Smoking Index at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Mental Health Resource Utilization at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Medical Care Resource Utilization at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Drug Abuse Screening Test (DAST-10) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Tablets Routine Questionnaire (TRQ) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Addiction Severity Index (ASI) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change from Baseline in Michigan Diabetes Research and Training Center's Brief Diabetes Knowledge Test at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Perceived Diabetes Self-Management Scale (PDSMS) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Perceived Mental Health Self-Management Scale (PMHSMS) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Perceived Therapeutice Efficacy Scale for Diabetes (PTES for DM) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Insight and Treatment Attitudes Questionnaire (ITAQ) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Multi-dimensional Scale of Perceived Social Support (MSPSS) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Internalized Stigma for Mental Illness Scale (ISMI) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Barriers to Self-Care Scale (BSCS) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Active, not recruiting
212
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01410357
R01MH085665, R01MH085665
Yes
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
March 2014

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