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

This study is currently recruiting participants.
Verified January 2013 by National Institute of Mental Health (NIMH)
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
MetroHealth System
Information provided by (Responsible Party):
Martha Sajatovic, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01410357
First received: July 29, 2011
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Bipolar Disorder
Depression
Psychotic Disorders
Schizophrenia
 Behavioral: Targeted Training in Illness Management (TTIM)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improving Outcomes for Individuals With Serious Mental Illness and Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 212
Study Start Date: July 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410357

Contacts
Contact: Stephanie Wolfe Kanuch, M.Ed. 216-778-4184 skanuch@metrohealth.org
Contact: Kristin A Cassidy, MA 216-844-2834 kristin.cassidy@case.edu

Locations
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Stephanie Wolfe Kanuch, M.Ed.     216-778-4184     skanuch@metrohealth.org    
Contact: Kristin A Cassidy, MA     216-844-2834     kristin.cassidy@case.edu    
Principal Investigator: Martha Sajatovic, MD            
Principal Investigator: Neal V Dawson, MD            
Sponsors and Collaborators
Case Western Reserve University
National Institute of Mental Health (NIMH)
MetroHealth System
Investigators
Principal Investigator: Martha Sajatovic, MD Case Western Reserve University
Principal Investigator: Neal V Dawson, MD Case Western Reserve University
  More Information

No publications provided

Responsible Party: Martha Sajatovic, Professor of Psychiatry, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01410357     History of Changes
Other Study ID Numbers: R01MH085665, R01MH085665
Study First Received: July 29, 2011
Last Updated: January 3, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute of Mental Health (NIMH):
serious mental illness
diabetes

Additional relevant MeSH terms:
Mental Disorders
Bipolar Disorder
Depression
Depressive Disorder
Diabetes Mellitus
Psychotic Disorders
Schizophrenia
 Affective Disorders, Psychotic
Mood Disorders
Behavioral Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 21, 2013