NCT02469714

Brief Summary

The health care needs of people with serious mental illness are exacerbated by ethnic health disparities. Latinos with serious mental illness show significant health problems compared to other ethnic groups. Therefore, this project is to develop a meaningful peer-navigator program for Latinos with serious mental illness using community-based participatory research (CBPR). Investigators are currently working with seven Hispanic/Latinos with a mental illness that have formed a Consumer Research Team (CRT) that will guide this project. This project will identify and define the problem by conducting a mixed methods research thru qualitative interviews with various stakeholders defined by the investigator's CRT group. The qualitative findings will then be cross-validated in a quantitative survey by 100 Hispanic/Latinos with mental illness. This information will then be used to design an intervention using an integrated care model for Peer-Navigators. Feasibility, accessibility , acceptability and impact of the peer-navigator program will be then evaluated in a randomized control trial (RCT) with 100 Latinos with serious mental illness who will complete measures of physical health, mental health, service use and engagement at baseline, 4, 8, and 12 months. Investigators expect to show physical health improvement with the greater engagement observed in the peer navigator group. Investigators expect a similar improvement in mental health and quality of life as physical health concerns are diminished.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

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

First Submitted

Initial submission to the registry

June 5, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

September 23, 2019

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

June 5, 2015

Results QC Date

April 5, 2017

Last Update Submit

March 12, 2024

Conditions

Keywords

Patient NavigatorIntegrated CareLatinoMental health and wellnessPhysical health and wellness

Outcome Measures

Primary Outcomes (1)

  • Weekly Health Appointment Measure

    This scale represents the total achieved appointments and total scheduled appointments. Data was collected weekly and added up per month.The minimum is 0 ( no appointments ) with no maximum (participants were not limited to the number of appointments per week).

    Every week for up to 52 weeks

Secondary Outcomes (7)

  • Attitudes Toward Seeking Professional Psychological Help Scale (ATSPPH)

    Baseline (0), 4, 8, and 12 months

  • Empowerment Scale (EMP)

    Baseline (0), 4, 8, and 12 months

  • Recovery Assessment Scale (RAS)

    Baseline (0), 4, 8, and 12 months

  • Medical Outcome Study (SF-36)

    Baseline (0), 4, 8, and 12 months

  • Quality of Life Scale (QLS)

    Baseline (0), 4, 8, and 12 months

  • +2 more secondary outcomes

Study Arms (2)

Peer Navigator Intervention

EXPERIMENTAL

Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months.

Behavioral: Peer Navigator Intervention

Controlled

NO INTERVENTION

Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months

Interventions

Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group

Also known as: Peer Navigator
Peer Navigator Intervention

Eligibility Criteria

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

You may qualify if:

  • Identify ethnicity as Hispanic/Latino
  • Identify with experience with a mental illness

You may not qualify if:

  • Must be 18 years or older
  • Have case manager they met on a regular basis (every week for the past 4 months) for physical health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Illinois Institute of Technology

Chicago, Illinois, 60616, United States

Location

Related Publications (18)

  • Corrigan PW. Consumer satisfaction with institutional and community care. Community Ment Health J. 1990 Apr;26(2):151-65. doi: 10.1007/BF00752392.

    PMID: 2191833BACKGROUND
  • Corrigan PW, Jakus MR. The Patient Satisfaction Interview for partial hospitalization programs. Psychol Rep. 1993 Apr;72(2):387-90. doi: 10.2466/pr0.1993.72.2.387.

    PMID: 8488222BACKGROUND
  • Fischer EH, Turner JL. Orientations to seeking professional help: development and research utility of an attitude scale. J Consult Clin Psychol. 1970 Aug;35(1):79-90. doi: 10.1037/h0029636. No abstract available.

    PMID: 5487612BACKGROUND
  • Johansen R, Hestad K, Iversen VC, Agartz I, Sundet K, Andreassen OA, Melle I. Cognitive and clinical factors are associated with service engagement in early-phase schizophrenia spectrum disorders. J Nerv Ment Dis. 2011 Mar;199(3):176-82. doi: 10.1097/NMD.0b013e31820bc2f9.

    PMID: 21346488BACKGROUND
  • Rogers ES, Chamberlin J, Ellison ML, Crean T. A consumer-constructed scale to measure empowerment among users of mental health services. Psychiatr Serv. 1997 Aug;48(8):1042-7. doi: 10.1176/ps.48.8.1042.

    PMID: 9255837BACKGROUND
  • Rogers ES, Ralph RO, Salzer MS. Validating the empowerment scale with a multisite sample of consumers of mental health services. Psychiatr Serv. 2010 Sep;61(9):933-6. doi: 10.1176/ps.2010.61.9.933.

    PMID: 20810594BACKGROUND
  • Corrigan PW, Faber D, Rashid F, Leary M. The construct validity of empowerment among consumers of mental health services. Schizophr Res. 1999 Jul 27;38(1):77-84. doi: 10.1016/s0920-9964(98)00180-7.

    PMID: 10427613BACKGROUND
  • Corrigan PW, Giffort D, Rashid F, Leary M, Okeke I. Recovery as a psychological construct. Community Ment Health J. 1999 Jun;35(3):231-9. doi: 10.1023/a:1018741302682.

    PMID: 10401893BACKGROUND
  • Corrigan PW, Salzer M, Ralph RO, Sangster Y, Keck L. Examining the factor structure of the recovery assessment scale. Schizophr Bull. 2004;30(4):1035-41. doi: 10.1093/oxfordjournals.schbul.a007118.

    PMID: 15957202BACKGROUND
  • Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

    PMID: 1593914BACKGROUND
  • de Vet HC, Ader HJ, Terwee CB, Pouwer F. Are factor analytical techniques used appropriately in the validation of health status questionnaires? A systematic review on the quality of factor analysis of the SF-36. Qual Life Res. 2005 Jun;14(5):1203-18; dicussion 1219-21, 1223-4. doi: 10.1007/s11136-004-5742-3.

    PMID: 16047498BACKGROUND
  • Lehman AF. The well-being of chronic mental patients. Arch Gen Psychiatry. 1983 Apr;40(4):369-73. doi: 10.1001/archpsyc.1983.01790040023003.

    PMID: 6838316BACKGROUND
  • Lehman AF. The effects of psychiatric symptoms on quality of life assessments among the chronic mentally ill. Eval Program Plann. 1983;6(2):143-51. doi: 10.1016/0149-7189(83)90028-9.

    PMID: 10265063BACKGROUND
  • Corrigan PW, Buican B, McCraken S. The needs and resources assessment interview for severely mentally ill adults. Psychiatr Serv. 1995 May;46(5):504-5. doi: 10.1176/ps.46.5.504.

    PMID: 7627679BACKGROUND
  • Contopoulos-Ioannidis DG, Karvouni A, Kouri I, Ioannidis JP. Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review. BMJ. 2009 Jan 12;338:a3006. doi: 10.1136/bmj.a3006.

    PMID: 19139138BACKGROUND
  • Corrigan PW, Jakus MR. The reliability of severely mentally ill patients' report of treatment satisfaction. International Journal of Methods in Psychiatric Research 3: 215-219, 1993.

    BACKGROUND
  • Corrigan PW, Michaels PJ. Perceived availability of services scale. Chicago: CASD. 2012.

    BACKGROUND
  • Lehman AF. A quality of life interview for the chronically mentally ill. Evaluation and Program Planning 11(1): 51-62, 1988.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Mental DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Limitations and Caveats

Concerns to US Immigration and Customs Enforcement for those with undocumented residency status make some Latinos suspicious of institutions.Heterogeneity may influence solutions to health care concerns of these Latinos with serious mental illness.

Results Point of Contact

Title
Patrick Corrigan
Organization
Illinois Institute of Technology

Study Officials

  • Patrick Corrigan, Psy.D

    Illinois Institute of Technology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor of Psychology

Study Record Dates

First Submitted

June 5, 2015

First Posted

June 11, 2015

Study Start

August 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

March 15, 2024

Results First Posted

September 23, 2019

Record last verified: 2024-03

Locations