Study Stopped
Target sample size not reached for enrollment.
Study on the Impact of Patient Navigators on the Health Education and Quality of Life in Formerly Incarcerated Patients
Impact of Patient Navigators on Health Education and Quality of Life in Formerly Incarcerated Patients
1 other identifier
interventional
144
1 country
2
Brief Summary
This is a 3-year prospective randomized comparative study of the efficacy of patient navigation on health education, health related quality of life, healthcare utilization, and medical outcomes in formerly incarcerated individuals. Individuals will be randomized to the patient-navigator intervention or to a care-as-usual control condition. A total of 300 recently incarcerated individuals will be enrolled with 150 subjects each in the intervention and usual care group. The investigators hypothesize that the intervention will improve health education, health related quality of life, adherence to clinical appointments, glycemic/blood pressure control, and virologic suppression in HIV-infected. The results of this study will demonstrate interventions to eliminate health disparities in a highly marginalized group going through the transitional phase of re-entry into the community.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2014
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 15, 2014
CompletedFirst Posted
Study publicly available on registry
October 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedAugust 20, 2015
August 1, 2015
10 months
September 15, 2014
August 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Health Education Impact
Health education impact questionnaire (heiQ)
18 months
Quality of Life
Health related quality of life (HRQOL-14)
18 months
Secondary Outcomes (2)
Health Outcomes
18 months
Healthcare Utilization
18 months
Study Arms (2)
Patient Navigation
EXPERIMENTALIntensive Patient Navigation with Motivational Interviewing and Health Education for 8 months 18 month follow-up
Treatment as Usual
NO INTERVENTIONCase Management and Medical Care as provided by the Coming Home Program at Mount Sinai St. Luke's Institute of Advanced Medicine, Morningside Clinic
Interventions
Eligibility Criteria
You may qualify if:
- age 18 years or older
- English or Spanish speaking
- release from the correctional system within the previous 6 months
You may not qualify if:
- unable to provide informed consent
- report duration of incarceration of less than 5 days
- report history of incarceration more than 6 months ago
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mount Sinai St. Luke's
New York, New York, 10025, United States
Hunter College at The City University of New York
New York, New York, 10065, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Georgina Osorio, MD, MPH
St. Luke's-Roosevelt Hospital Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2014
First Posted
October 8, 2014
Study Start
June 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
August 20, 2015
Record last verified: 2015-08