Life Goals Collaborative Care to Improve Health Outcomes in Mental Disorders

NCT01487668 | Completed Results

• 1 other identifier: IIR 10-340
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder; Schizophrenia; Major Depressive Disorder; Schizoaffective Disorder; Cardiovascular Disease Risk

Keywords

chronic mental disorders; cardiovascular disease; behavior change

Outcome Measures

Primary Outcomes (1)

• Physical Health-related Quality of Life

  The outcome is measures by changes in the Veterans short form 12-item (VR-12) survey, which includes a physical and mental health component score (PCS and MCS, respectively). Each component score (PCS and MCS) has a range of 0-100, with a higher score on the PCS and MCS indicating better outcome, or better physical or mental health-related quality of life, respectively.

  12 months

Secondary Outcomes (1)

• Improved Mental Health-related Quality of Life

  12 months

Study Arms (2)

Arm 1 - Usual Care

NO INTERVENTION

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.

Arm 2 - Life Goals Collaborative Care

EXPERIMENTAL

Behavioral: Life Goals Collaborative Care

Interventions

Life Goals Collaborative Care BEHAVIORAL

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.

Arm 2 - Life Goals Collaborative Care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (6)

• Kilbourne AM, Goodrich DE, Lai Z, Post EP, Schumacher K, Nord KM, Bramlet M, Chermack S, Bialy D, Bauer MS. Randomized controlled trial to assess reduction of cardiovascular disease risk in patients with bipolar disorder: the Self-Management Addressing Heart Risk Trial (SMAHRT). J Clin Psychiatry. 2013 Jul;74(7):e655-62. doi: 10.4088/JCP.12m08082.

  PMID: 23945460 RESULT

• O'Donnell AN, Williams M, Kilbourne AM. Overcoming roadblocks: current and emerging reimbursement strategies for integrated mental health services in primary care. J Gen Intern Med. 2013 Dec;28(12):1667-72. doi: 10.1007/s11606-013-2496-z. Epub 2013 Jun 4.

  PMID: 23733375 RESULT

• Goodrich DE, Kilbourne AM, Nord KM, Bauer MS. Mental health collaborative care and its role in primary care settings. Curr Psychiatry Rep. 2013 Aug;15(8):383. doi: 10.1007/s11920-013-0383-2.

  PMID: 23881714 RESULT

• Waxmonsky J, Kilbourne AM, Goodrich DE, Nord KM, Lai Z, Laird C, Clogston J, Kim HM, Miller C, Bauer MS. Enhanced fidelity to treatment for bipolar disorder: results from a randomized controlled implementation trial. Psychiatr Serv. 2014 Jan 1;65(1):81-90. doi: 10.1176/appi.ps.201300039.

  PMID: 24129806 RESULT

• Kilbourne AM, Bramlet M, Barbaresso MM, Nord KM, Goodrich DE, Lai Z, Post EP, Almirall D, Verchinina L, Duffy SA, Bauer MS. SMI life goals: description of a randomized trial of a collaborative care model to improve outcomes for persons with serious mental illness. Contemp Clin Trials. 2014 Sep;39(1):74-85. doi: 10.1016/j.cct.2014.07.007. Epub 2014 Jul 30.

  PMID: 25083802 RESULT

• Kilbourne AM, Barbaresso MM, Lai Z, Nord KM, Bramlet M, Goodrich DE, Post EP, Almirall D, Bauer MS. Improving Physical Health in Patients With Chronic Mental Disorders: Twelve-Month Results From a Randomized Controlled Collaborative Care Trial. J Clin Psychiatry. 2017 Jan;78(1):129-137. doi: 10.4088/JCP.15m10301.

  PMID: 27780336 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Schizophrenia; Depressive Disorder, Major; Psychotic Disorders; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Depressive Disorder

Results Point of Contact

• Title: Amy M. Kilbourne, PhD, MPH
• Organization: Department of Veterans Affairs, VA Ann Arbor Healthcare System

amy.kilbourne@va.gov

734-845-3452

Study Officials

• Amy M. Kilbourne, PhD MPH

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: December 7, 2011
• Study Start: December 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 22, 2016
• Results First Posted: January 22, 2016

Record last verified: 2015-12

Locations

US (1)