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NCT04977583 · ClinicalTrials.gov registry record · NA
Unmet Social Needs Study
A NA study of Hypertension and Diabetes Mellitus, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 479
- Enrollment target
- 3
- Study locations
NCT04977583: Completed NA study of Hypertension and Diabetes Mellitus, sponsored by VA Office of Research and Development.
NCT04977583 is a NA study of Hypertension and Diabetes Mellitus that has completed, run by VA Office of Research and Development. The registered enrollment target is 479 participants, below the 3,506-participant average among 470 other Hypertension trials with a reported enrollment target (86% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04977583, a NA study of Hypertension and Diabetes Mellitus, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 479 participants
- Enrollment target
- 3
- Study locations
Study Summary
The impacts of unmet social needs, such as homelessness, inconsistent access to food, and exposure to violence on health are well-established, especially for cardiovascular disease. A limited but growing body of evidence suggests that screening for and addressing these needs - also referred as social determinants of health -- in clinic settings helps to connect patients to resources to address unmet needs and has the potential to improve health outcomes. Veterans carry a high burden of unmet needs. At present, VA systematically screens for only two unmet needs; homelessness and food insecurity. The investigators propose to assess the efficacy of systematically screening Veterans for nine unmet needs (i.e., housing, food insecurity, utility insecurity, transportation, legal problems, employment, safety, stress, and social isolation), and compare the effect of referral mechanisms of varying intensity on Veterans' connection to resources, reduction of unmet needs, treatment adherence, reduced preventable hospitalizations, and clinical outcomes.
Primary Outcome
Defined as participant connecting to one or more resources since the index unmet need screen and assessed via a participant survey administered 8 weeks following the index unmet need screen. The survey will ask: "Since you completed the unmet social need screen on (insert date), were you able to connect with any of the programs or resources for help with (insert need(s) identified)".
Conditions Studied
Interventions
- BEHAVIORAL Unmet Need Screening
- BEHAVIORAL Unmet Need Referral - Resource Sheet
- BEHAVIORAL Unmet Need Referral Assistance
Study Locations (3)
Massachusetts
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA - Boston
Pennsylvania
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA - Philadelphia
South Carolina
- Ralph H. Johnson VA Medical Center, Charleston, SC - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 479 participants |
| Start Date | 2022-04-29 |
| Est. Completion | 2023-12-15 |
| Phase | NA |
What the finished NCT04977583 record still lists
NCT04977583 is an interventional study that assigns participants to a tested intervention. The registered 479 participants enrollment target is mid-sized for trials with a published cap, below the 3,506-participant average among 470 other Hypertension trials with a reported enrollment target (86% lower).
The record links to 4 conditions, with Hypertension appearing as the primary indexed condition, and to 3 interventions - of which Unmet Need Screening is the first listed.
NCT04977583 reports a single indexed study location in Massachusetts, Pennsylvania, South Carolina.
Frequently Asked Questions
What is clinical trial NCT04977583 about?
NCT04977583 is a clinical study titled "Unmet Social Needs Study". The impacts of unmet social needs, such as homelessness, inconsistent access to food, and exposure to violence on health are well-established, especially for cardiovascular disease. A limited but growing body of evidence suggests that screening for and addressing these needs - also referred as socia...
What is the current status of trial NCT04977583?
This trial is currently completed. It is a NA study. The enrollment target is 479 participants. The study started on 2022-04-29. Estimated completion is 2023-12-15.
What conditions does trial NCT04977583 study?
This clinical trial studies the following conditions: Hypertension, Diabetes Mellitus, Cardiovascular Disease, Hyperlipidemia.
What interventions are being tested in trial NCT04977583?
The interventions under investigation include: Unmet Need Screening (BEHAVIORAL), Unmet Need Referral - Resource Sheet (BEHAVIORAL), Unmet Need Referral Assistance (BEHAVIORAL).
Who is sponsoring clinical trial NCT04977583?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04977583 being conducted?
This trial has 3 study locations across Massachusetts, Pennsylvania, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04977583's enrollment target sits among peer trials
479 130th of 470 higher than 341 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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