Realizing Opportunities for Self Empowerment

Depression Clinical Trial

— ROSE  

Official title:

Patient Priorities and Community Context: Navigation for Disadvantaged Women With Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02087956
• Other study ID #: AD-12-11-4261
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: August 2017

Study information

• Verified date: January 2019
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether priority-based patient navigation will improve patient satisfaction, quality of life (QOL), and depression when compared to screening-and-referral for socioeconomically disadvantaged women's health patients with depression. The investigators goal is to establish patient-driven, effective, generalizable, and disseminable interventions to reduce depression-related disparities and improve outcomes.

Description:

• In this comparative effectiveness study, 200 participants who are patients at the University of Rochester Women's Health Practice or Highland Woman's Health and report significant depressive symptoms will be randomized to either PSP (Personal Support for Progress) or ESR (Enhanced Screening and Referral). Participants assigned to PSP will work with a patient navigator to prioritize their concerns, develop a personalized care plan, and implement their plan. Participants assigned to ESR will receive a personalized report of community resources that may be helpful for their identified needs.

• The investigators will use a simple 1:1 randomized design with treatment assignment being conducted using a random number generator. All analyses will follow an intent-to-treat protocol, such that all participants randomized will be followed for data collection and analyzed according to her randomized condition

• Each participant will be assessed 4 times for outcome changes: at baseline, post treatment (4 months), and two follow up ( at 7 and 10 months).

• Assessments are self report on iPads and they are linked directly to a Red Cap database.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with depression (PHQ9 score 10 or higher)

• Patient of University of Rochester Women's Health Practice or Highland Women's Health

• Monroe County resident

• English speaking

Exclusion Criteria:

• Currently receiving case management services

• In need of acute psychiatric services

• Unable to commit to the duration of the project

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Navigation
The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed.
• Enhanced Screening and Referral
Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free.

Locations

Country	Name	City	State
United States	University of Rochester, Women Health Practice	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Quality of Life	We will use the WHOQOL-BREF measure. The WHOQOL-bref contains 26 items; the first two questions evaluate self-perceived quality of life and satisfaction with health.The remaining 24 questions represent four domains: physical, psychological, social relationships and environment.; The WHOQOL-bref contains five Likert style response scales: "very poor to very good" (evaluation scale), "very dissatisfied to very satisfied" (evaluation scale), "none to extremely" (intensity scale), "none to complete" (capacity scale) and "never to always" (frequency scale).The mean score in each domain indicates the individual's perception of their satisfaction with each aspect of their life, relating it with quality of life. The higher the score, the better this is perceived to be. Total score was computed by summing all 26 items. The possible range is from 26 to 130.	Post treatment (4 months after enrollment)
Primary	Depression Change Outcome Measure	Depression was measured by PHQ-9, a screen for major depressive disorder with good discriminant validity and sensitivity to change validated in Ob/Gyn settings, and with pregnant and postpartum women, and with women of color. Scale ranges 0-27. Higher the score, higher severity of depression and cutpoints of 5, 10, 15 and 20 representing mild, moderate, moderately severe and severe levels of depressive symptoms.	baseline, post treatment (4 months after enrollment), 3 months and 6 months follow up (7 and 10 months after enrollment)
Primary	Client Satisfaction Questionnaire- 8 Items	The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report instrument to assess subjective satisfaction with treatment which was administered to all participants post-treatment We analyzed 4 items: CSQ1: "How would you rate the quality of service you have received?", CSQ 3: "To what extent has our program met your needs?", CSQ 6: "Have the services you received helped you to deal more effectively with your problems?" and CSQ 7: "In an overall, general sense, how satisfied are you with the service you have received?" (1 = Excellent, 2 = Good, 3 = Fair, 4 = Poor). We are reporting on CSQ 1 outcome.	Post treatment- 4 months after enrollment, 3 and 6 months follow-up (7 and 10 months after the enrollment)
Secondary	Domestic Violence (Feldhaus)	Feldhaus Partner Violence Screen is 3 items measure assessing physical abuse by partner in the past year. Scale range: 0-3; higher the score higher frequency of physical abuse.	baseline, post treatment (4 months after enrollment), 3 and 6 months follow-up (7 and 10 months after enrollment)