Life Goals Collaborative Care to Improve Health Outcomes in Mental Disorders

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01487668
First received: November 21, 2011
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

Persons with serious mental illness (SMI) are at increased risk of cardiovascular disease (CVD). The goals of this study are to test a treatment, Life Goals Collaborative Care to help promote health behavior change and improve mental health and physical health-related quality of life, as well as to get feedback from patients and providers on what is needed to help better coordinate the physical and mental health care of these patients.


Condition Intervention
Bipolar Disorder
Schizophrenia
Major Depressive Disorder
Schizoaffective Disorder
Cardiovascular Disease Risk
Behavioral: Life Goals Collaborative Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Life Goals Collaborative Care to Improve Health Outcomes in Mental Disorders

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • overall health-related quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in VR-12 physical and mental health scores from baseline to 12 months


Secondary Outcome Measures:
  • improved mental health-related quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in SF-12 mental health scores from baseline to 12 months

  • improved health behaviors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • change in cardiovascular risk factors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    change in systolic and diastolic blood pressure (mm/Hg) and body mass index (BMI) from baseline to 12 months


Enrollment: 251
Study Start Date: December 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm 1
Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
Behavioral: Life Goals Collaborative Care
LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.

Detailed Description:

Background: VA patients with serious mental illnesses (SMI- e.g., schizophrenia, bipolar disorder) die an average of 13-18 years earlier compared to the general U.S. population, mostly from cardiovascular disease (CVD). Increased risk of CVD and related risk factors in persons with SMI is attributed to patient, provider, and system-level barriers including unhealthy behaviors exacerbated by mental health-related symptoms and barriers to access and continuity of care between physical and mental health services.

Objectives: The primary aim of this randomized controlled effectiveness trial (RCT) is to determine whether VA patients with SMI receiving Life Goals Collaborative Care (LGCC), a program that combines customized behavioral change strategies with chronic care management for SMI will experience, within 12 months: a) improved medical outcomes (e.g., reduced CVD risk factors, improved physical health-related quality of life), b) improved mental health outcomes, including reduced psychiatric symptoms or improved mental health-related quality of life or c) improved health behaviors, compared to VA patients with SMI receiving enhanced treatment as usual (i.e., dissemination of health behavior change materials in addition to standard VA medical and psychiatric care). Secondary aims that will inform further implementation of LGCC will be to assess utilization and cost differences of LGCC versus treatment as usual, determine the patient factors associated with LGCC treatment response, and identify the organizational factors associated with LGCC implementation.

Methods: LGCC is a groundbreaking psychosocial and behavior change intervention that is based on the Chronic Care Model (CCM) and consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages. We will enroll 376 individuals diagnosed with SMI and a CVD risk factor who are receiving care within the VA Ann Arbor Healthcare System mental health clinic, and who will be randomized to receive LGCC or enhanced treatment as usual. Key outcomes include changes in CVD risk factors (e.g., blood pressure, BMI), psychiatric symptoms, health-related quality of life, health behaviors (e.g., physical activity), and inpatient and outpatient use assessed at 6 and 12 months.

Impact: This study addresses VA HSR&D research priorities related to mental health and care of complex, chronic conditions, and is consistent with the priorities of the VHA's Office of Mental Health Services (Patient Care Services), 10NC, and the National Center for Health Promotion and Disease Prevention. Serious mental illness (SMI) is associated with significant disability, decreased quality of life, and a decreased life span. The VA is undergoing two major quality improvement initiatives: the Patient-Aligned Care Team (PACT), which involves enhanced access and continuity of care based on Chronic Care Model (CCM) principles, and dissemination of behavioral medicine programs. However, to date these programs have not been fully adapted to address gaps in quality or outcomes of care for Veterans with SMI. Findings from this RCT will inform ongoing VA transformational initiatives around systems redesign and behavioral medicine programs for Veterans with SMI and determine whether a customized CCM-behavioral medicine strategy is most effective in improving outcomes for this vulnerable group.

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of serious mental illness (schizophrenia, bipolar disorder, other psychosis, major depressive disorder, or other recurrent depression or affective disorder)
  • Have at least one of the following risk factors for CVD (cardiovascular disease):

    • Body mass index (BMI) >28 or waist circumference of >35 (women) or >40 (men) inches OR
    • Self-reported diagnosis of hypertension ("high blood pressure"), dyslipidemia ("high cholesterol") or diabetes or high blood sugar OR
    • Documentation in the medical record of a diagnosis of or treatment for hypertension (defined as documented diagnosis or blood pressure of >140/90 on 2 occasions or prescription for an antihypertensive medication), dyslipidemia (documented diagnosis or LDL>160 or prescription for a lipid-lowering medication) or diabetes mellitus (documented diagnosis or HbA1C >7% or current prescription for oral hypoglycemic therapy)

Exclusion Criteria:

  • Have unresolved substance intoxication or withdrawal, such as appearing to be intoxicated (e.g., incoherent, slurred speech), or experiencing withdrawal symptoms from substance abuse at the time of enrollment.
  • Are unwilling or unable to provide informed consent or comply with study requirements at the time of enrollment (e.g., unable to complete forms or attend sessions due to substantial functional limitations).
  • Active suicidal ideation at time of enrollment (focused interventions are more appropriate for this group)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487668

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113-0170
Sponsors and Collaborators
Investigators
Principal Investigator: Amy M. Kilbourne, PhD MPH VA Ann Arbor Healthcare System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01487668     History of Changes
Other Study ID Numbers: IIR 10-340
Study First Received: November 21, 2011
Last Updated: June 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
chronic mental disorders
cardiovascular disease
behavior change

Additional relevant MeSH terms:
Cardiovascular Diseases
Schizophrenia
Psychotic Disorders
Depressive Disorder, Major
Depressive Disorder
Bipolar Disorder
Depression
Mental Disorders
Disease
Schizophrenia and Disorders with Psychotic Features
Mood Disorders
Affective Disorders, Psychotic
Behavioral Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014