The e-SINCERE Study

NCT07174466 | Recruiting

• 2 other identifiers: 001818911R01NR021501-01
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Social Determinants of Health (SDOH); Digital Health Literacy; Health Services Utilization

Outcome Measures

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.

  6 months after randomization

Secondary Outcomes (3)

• Health-related quality of life (PROMIS Global Health)

  Baseline, 2 weeks, 3 months, and 6 months after randomization

• Emergency department utilization (all-cause ED visits)

  6 months after randomization

• Digital access stability (phone connectivity)

  6 months after randomization

Study Arms (3)

Arm 1: Control - Standard Referral to 211

ACTIVE COMPARATOR

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

Arm 2: Phone - Bridge Phone to 211

EXPERIMENTAL

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)

Arm 3: Navigation - Digital Navigator + 211

EXPERIMENTAL

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

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.

Arm 1: Control - Standard Referral to 211

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.

Arm 2: Phone - Bridge Phone to 211

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.

Arm 3: Navigation - Digital Navigator + 211

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Andrea Wallace: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Andrea Wallace, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ernest Grigorian, MS

CONTACT

801-585-7194; Ernest.Grigorian@utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Services to which participants are referred will not be aware of the participant's inclusion in the research study or their study arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 16, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)