NCT02183844

Brief Summary

It is important that individuals with serious mental illness make informed choices among alternative healthcare treatments based on their preferences. However, at present, individuals' preferences are often not being elicited, nor used to guide which treatments are made available. In this pilot project, the investigators implement and evaluate a computerized method for assessing treatment preferences of individuals with schizophrenia. The investigators use weight management treatments for this initial test of the system. If this assessment method is found to predict treatment use and satisfaction, it can be used to guide implementation of treatments that improve outcomes while meeting individuals' preferences.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

3.4 years

First QC Date

June 30, 2014

Last Update Submit

November 2, 2017

Conditions

Keywords

Medical InformaticsPatient-CenteredHealthcare PreferencesHealth EducationQuality ImprovementWeight LossPersonal SatisfactionHumansCognitionBody Weight

Outcome Measures

Primary Outcomes (4)

  • Days until using weight services

    Utilization of the weight services offered. This includes the number of days until starting to use weight services. This is assessed using information regarding attendance at weight services, and by survey administered by interview.

    3 months

  • Participant preferences regarding weight services

    Individuals' preferences are assessed regarding different attributes of weight treatments. These are assessed using computerized conjoint analysis methods.

    Baseline

  • Satisfaction with the weight services provided

    Satisfaction with the weight services provided. This is assessed using the Client Satisfaction Questionnaire administered by interview.

    3 months

  • Number of weight services used

    Utilization of the weight services offered. This includes the number of weight service sessions attended. This is assessed using information regarding attendance at weight services, and by survey administered by interview.

    3 months

Secondary Outcomes (1)

  • Feasibility and acceptability of implementing preference assessment

    Baseline

Other Outcomes (1)

  • Aspects of the Theory of Planned Behavior

    Baseline and 3 months

Study Arms (1)

Psychosocial Weight Intervention

EXPERIMENTAL

Weekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses

Behavioral: Psychosocial Weight Intervention

Interventions

Weekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses

Psychosocial Weight Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of schizophrenia
  • age 18 or older
  • Body Mass Index (BMI) of either 28.0-29.9 and gained 10 pounds in the last 3 months; OR, BMI of 30 or above
  • able to provide informed consent

You may not qualify if:

  • a medical condition for which a weight program is contraindicated
  • pregnant and nursing mothers
  • attendance at a psychosocial intervention for weight management in the past month
  • individuals with legal conservators who manage informed consent
  • can not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Center for Health Services and Society

Los Angeles, California, 90024, United States

Location

Related Publications (5)

  • Young AS, Niv N, Chinman M, Dixon L, Eisen SV, Fischer EP, Smith J, Valenstein M, Marder SR, Owen RR. Routine outcomes monitoring to support improving care for schizophrenia: report from the VA Mental Health QUERI. Community Ment Health J. 2011 Apr;47(2):123-35. doi: 10.1007/s10597-010-9328-y. Epub 2010 Jul 25.

    PMID: 20658320BACKGROUND
  • Cohen AN, Chinman MJ, Hamilton AB, Whelan F, Young AS. Using patient-facing kiosks to support quality improvement at mental health clinics. Med Care. 2013 Mar;51(3 Suppl 1):S13-20. doi: 10.1097/MLR.0b013e31827da859.

    PMID: 23407006BACKGROUND
  • Brown AH, Cohen AN, Chinman MJ, Kessler C, Young AS. EQUIP: implementing chronic care principles and applying formative evaluation methods to improve care for schizophrenia: QUERI Series. Implement Sci. 2008 Feb 15;3:9. doi: 10.1186/1748-5908-3-9.

    PMID: 18279505BACKGROUND
  • Chinman M, Young AS, Schell T, Hassell J, Mintz J. Computer-assisted self-assessment in persons with severe mental illness. J Clin Psychiatry. 2004 Oct;65(10):1343-51. doi: 10.4088/jcp.v65n1008.

    PMID: 15491237BACKGROUND
  • Young AS. The client, the clinician, and the computer. Psychiatr Serv. 2010 Jul;61(7):643. doi: 10.1176/ps.2010.61.7.643. No abstract available.

    PMID: 20591993BACKGROUND

MeSH Terms

Conditions

Mental DisordersSchizophreniaOverweightObesityHealth EducationWeight LossPersonal SatisfactionBody Weight

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorBody Weight Changes

Study Officials

  • Alexander S Young, MD, MSHS

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2014

First Posted

July 8, 2014

Study Start

June 16, 2014

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

November 6, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations