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RecruitingNCT07174466e-SINCEREUpdated Sep 25, 2026

The e-SINCERE Study

An interventional study of Standard Referral to 211 and e-SINCERE (Phone Support) in Social Determinants of Health (SDOH), Digital Health Literacy and Health Services Utilization, sponsored by Andrea Wallace. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Andrea Wallace · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The e-SINCERE study will evaluate whether providing stable cell phones and digital navigation assistance helps patients overcome ICT barriers and connect more successfully with community services. The study will begin with patients in the UHealth ED, with additional sites added in the future, and will involve working with community service providers and policy leaders to refine and implement the intervention. Findings from this study may guide the development of future programs and policies to improve access to services for patients facing economic and technological barriers.

02

Conditions studied

  • Social Determinants of Health (SDOH)
  • Digital Health Literacy
  • Health Services Utilization
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Community Advisory Board Members

Health system, governmental, and community service stakeholders

Able to understand English

Adult (> 18 years)

- General screening population:

Any patient who completes the SINCERE screener.

Able to understand or read English or Spanish.

- Survey study inclusion criteria:

Any patient who completes the SINCERE screener who has connected with 211 for service outreach

Able to understand or read English or Spanish.

Adult (> 18 years)

Exclusion criteria

Exclusion Criteria:

  • Those unable to communicate verbally in English or Spanish
  • Those living in nursing facilities, or those who are not otherwise responsible for self-care
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Active comparator
    Arm 1: Control - Standard Referral to 211

    Participants receive usual care plus a referral to United Way 211 for assistance with social needs. No additional study-provided phone or navigation support is given.

    Other: Standard Referral to 211

  • Experimental
    Arm 2: Phone - Bridge Phone to 211

    Participants receive a study-provided cellphone to ensure stable phone access. They are connected by phone to United Way 211 for assistance with social needs.

    Behavioral: e-SINCERE (Phone Support)

  • Experimental
    Arm 3: Navigation - Digital Navigator + 211

    Participants receive a study-provided cellphone and direct support from a Digital Navigator. The Navigator assists participants in accessing United Way 211 and helps troubleshoot barriers to connecting with services.

    Behavioral: e-SINCERE (Digital Navigation)

Interventions

  • OtherStandard Referral to 211

    Participants receive a standard referral to United Way 211 for assistance with social needs. 211 specialists contact referred patients, provide available service referrals, and follow up in an ad-hoc manner as per standard 211 protocols.

  • Behaviorale-SINCERE (Phone Support)

    Participants receive a study-provided cellphone to ensure stable phone access. Using this device, participants are connected to United Way 211 specialists, who provide referral services for identified social needs. This intervention focuses on overcoming communication barriers that might otherwise prevent successful service connection.

  • Behaviorale-SINCERE (Digital Navigation)

    Participants receive a study-provided TracFone and direct support from a trained Digital Navigator. The Digital Navigator assists participants with accessing United Way 211 services, troubleshooting barriers to phone or internet use, and reinforcing follow-through on referrals. This arm is designed to provide enhanced, structured navigation support to address digital access barriers and increase successful service connections.

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What researchers measure

Primary outcomes

  1. Successful connection to community social services (any service)

    Proportion of participants who have at least one documented successful connection to a community social service (e.g., housing assistance, utilities, food support, transportation) within 6 months. Successful connection is defined as a recorded positive outcome in 211 or ServicePoint (client reached and service initiated) or participant self-report confirmed by case notes.

    Time frame: 6 months after randomization

Secondary outcomes

  1. Health-related quality of life (PROMIS Global Health)

    Change in PROMIS Global Health T-score from baseline to 6 months. Higher scores indicate better overall physical and mental health. Analysis will compare mean change between arms.

    Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization

  2. Emergency department utilization (all-cause ED visits)

    Number of all-cause ED visits per participant during the 6-month follow-up period, obtained from the institution's EDW and participant self-report for non-UHealth visits. Analysis will compare mean visits and proportion with any ED revisit between arms.

    Time frame: 6 months after randomization

  3. Digital access stability (phone connectivity)

    Proportion of participants in the phone/navigation arms with continuous phone connectivity (TracFone active and reachable) for at least 5 of 6 months. Connectivity assessed via phone service logs and navigator contact attempts.

    Time frame: 6 months after randomization

06

Study locations

1 of 1 sites recruiting
  • University of Utah
    Salt Lake City, Utah 84112, United States
    Recruiting
07

References and documents

Publications

  • Wallace AS, Luther BL, Simonsen SE, Jackson S, Grigorian E, Wong B. Evaluating the impact of stable cellphone access and digital navigation on 6-month health outcomes and service connection in emergency care: protocol for a randomised controlled trial. BMJ Open. 2026 Jul 24;16(7):e113945. doi: 10.1136/bmjopen-2025-113945. PubMed 42498479 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07174466
Lead sponsor
Andrea Wallace
Collaborators
National Institute of Nursing Research (NINR)
Responsible party
Andrea Wallace (Professor, University of Utah) — Sponsor-investigator
First posted
Sep 16, 2025
Start date
Aug 8, 2025
Primary completion
Aug 31, 2028 (estimated)
Completion
Aug 31, 2029 (estimated)
Last update
Sep 25, 2026

Study contacts

Ernest Grigorian, MS
Contact
Ernest.Grigorian@utah.edu
801-585-7194
Andrea Wallace, PhD
principal investigator · University of Utah

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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