DepressionROSENCT02087956
Realizing Opportunities for Self Empowerment
A study testing Navigation and Enhanced Screening and Referral in people with Depression, run by University of Rochester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression
- What is being tested?
- Navigation and Enhanced Screening and Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently receiving case management services
- In need of acute psychiatric services
- Unable to commit to the duration of the project
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester, Women Health Practice
Rochester, New York, 14620
About this study
Official title: Patient Priorities and Community Context: Navigation for Disadvantaged Women With Depression
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.
Read the detailed 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.
- Conditions
- Depression
- Being tested
- Navigation, Enhanced Screening and Referral
- Keywords
- Women, Depression, Socioeconomically Disadvantaged, Navigation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavigationBehavioural
Also called mentoring
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 ReferralBehavioural
Also called Comprehensise health result screening
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Support for Progress (PSP) | Active comparator | In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan. Receives: Behavioral: Navigation |
| Enhanced Screening and Referral (ESR) | Active comparator | (ESR)- participant will receive personal report of their current needs and list of resources available in the community. Receives: Behavioral: Enhanced Screening and Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post treatment (4 months after enrollment)
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.
Measured: baseline, post treatment (4 months after enrollment), 3 months and 6 months follow up (7 and 10 months after enrollment)
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.
Measured: Post treatment- 4 months after enrollment, 3 and 6 months follow-up (7 and 10 months after the enrollment)
Secondary outcomes (1)
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.
Measured: baseline, post treatment (4 months after enrollment), 3 and 6 months follow-up (7 and 10 months after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Ellen Poleshuck, University of Rochester
- Investigators
- Ellen Poleshuck, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087956
- Sponsor's protocol ID
- AD-12-11-4261
- Acronym
- ROSE
- Status last verified
- Jan 2019
- First submitted
- 12 Mar 2014
- Last updated
- 7 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Priorities and Community Context: Navigation for Disadvantaged Women With Depression
- ClinicalTrials.gov ID
- NCT02087956
- Acronym / sponsor ID
- ROSE / AD-12-11-4261
- Conditions
- Depression
- Keywords
- Women, Depression, Socioeconomically Disadvantaged, Navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Jan 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Posted 7 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Support for Progress (PSP) | Active comparator | Behavioral: NavigationIn Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan. |
| Enhanced Screening and Referral (ESR) | Active comparator | Behavioral: Enhanced Screening and Referral(ESR)- participant will receive personal report of their current needs and list of resources available in the community. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Currently receiving case management services
- In need of acute psychiatric services
- Unable to commit to the duration of the project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NavigationAlso: mentoringThe 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. | Behavioural | Personalized Support for Progress (PSP) |
| Enhanced Screening and ReferralAlso: Comprehensise health result screeningPatients 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. | Behavioural | Enhanced Screening and Referral (ESR) |
Primary outcome
Patient Quality of Life
Time frame: Post treatment (4 months after enrollment)
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.
Depression Change Outcome Measure
Time frame: baseline, post treatment (4 months after enrollment), 3 months and 6 months follow up (7 and 10 months after enrollment)
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.
Client Satisfaction Questionnaire- 8 Items
Time frame: Post treatment- 4 months after enrollment, 3 and 6 months follow-up (7 and 10 months after the enrollment)
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.
1 secondary outcome
Domestic Violence (Feldhaus)
Time frame: baseline, post treatment (4 months after enrollment), 3 and 6 months follow-up (7 and 10 months after enrollment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Poleshuck, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation and Enhanced Screening and Referral in people with Depression, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Quality of Life (time frame: Post treatment (4 months after enrollment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.