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SINCERE Intervention for COVID-19 Health Disparities (SINCERE Trial)
N/A
Recruiting
Led By Andrea Wallace, PhD
Research Sponsored by Andrea Wallace
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult (> 17 years)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2-week, 4-week and 12-week surveys
Awards & highlights
SINCERE Trial Summary
This trial is testing a strategy of universal social needs screening, community-based service referrals, and telephonic follow-up to see if it prevents COVID-19 transmission and addresses the secondary health effects of the pandemic.
Who is the study for?
This trial is for adults over 17 who have social needs and are willing to get help from community services after visiting certain emergency departments or COVID-19 testing sites. They must be reachable by phone or able to complete surveys online, and speak English or Spanish. It's not for those in nursing homes or unable to communicate verbally.Check my eligibility
What is being tested?
The SINCERE intervention includes universal screening for social needs, referrals to community services, and follow-up calls. The study tests if these steps can prevent COVID-19 spread among vulnerable groups and improve health outcomes following the pandemic's socioeconomic impacts.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like screenings, referrals, and follow-ups rather than drugs or medical procedures, traditional side effects are not expected. However, participants may experience stress or discomfort during discussions of personal social needs.
SINCERE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 17 years.
SINCERE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2-week, 4-week and 12-week surveys
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2-week, 4-week and 12-week surveys
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Anxiety over 12-week time period
Change in Depression over 12-week time period
Change in Global Health over 12-week time period
SINCERE Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Call + Resources + Scheduled Follow-UpExperimental Treatment1 Intervention
Participants receive standard care typically provided to 211 callers plus scheduled follow-up calls according to the Scheduled Follow-Up intervention description.
Group II: Call + Resources + SINCEREExperimental Treatment1 Intervention
Participants receive standard care typically provided to 211 callers plus scheduled follow-up calls according to the SINCERE intervention description (scheduled follow up with active collaborative goal setting).
Group III: Call + ResourcesActive Control1 Intervention
Participants receive standard care typically provided to 211 callers, including ad hoc follow-up.
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Who is running the clinical trial?
Andrea WallaceLead Sponsor
2 Previous Clinical Trials
9,643 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,375,061 Total Patients Enrolled
2 Trials studying COVID-19
681 Patients Enrolled for COVID-19
Andrea Wallace, PhDPrincipal InvestigatorUniversity of Utah
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 17 years.I live in a nursing facility or need help with daily activities.You have completed the referral process at specific medical facilities and have indicated that you need and are willing to receive low-cost or free services from the United Way 211 community referral service.I can be contacted by phone or can complete surveys via text or email.I speak English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Call + Resources
- Group 2: Call + Resources + Scheduled Follow-Up
- Group 3: Call + Resources + SINCERE
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any opportunities to enroll in this research endeavor?
"According to the data found on clinicaltrials.gov, this medical experiment is currently recruiting participants. This research project was first shared with the public on September 27th 2021 and saw its last amendment made in March of 2022."
Answered by AI
How many individuals have subscribed to this research project?
"Affirmative. Clinicaltrials.gov records demonstrate that this trial, which was initialy posted on September 27th 2021, is actively enrolling participants. Approximately 1500 patients have to be recruited from 1 medical centre."
Answered by AI
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