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Recruiting

NCT Number: NCT07174466

The e-SINCERE Study

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.

Recruiting

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Key information

Conditions

Social Determinants of Health (SDOH) Behavior Digital Health Literacy Health Behavior Health Services Utilization Patient Acceptance of Health Care Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Standard Referral to 211

Other

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.

e-SINCERE (Phone Support)

Behavioral

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.

e-SINCERE (Digital Navigation)

Behavioral

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.

Primary outcomes

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

    Time frame: 6 months after randomization

    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.

Secondary outcomes

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

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

    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.

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

    Time frame: 6 months after randomization

    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.

  3. Digital access stability (phone connectivity)

    Time frame: 6 months after randomization

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ernest Grigorian, MS

CONTACT

[email protected]

801-585-7194

Sponsors and collaborators

Lead sponsor

Andrea Wallace

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Enhanced Digital Access to Bridge Social Needs and Reduce Health Disparities: The e-SINCERE Study

Acronym: e-SINCERE

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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