Social Determinants of Health (SDOH)e-SINCERENCT07174466
The e-SINCERE Study
A study testing Standard Referral to 211, e-SINCERE (Phone Support) and e-SINCERE (Digital Navigation) in people with Social Determinants of Health (SDOH) and Digital Health Literacy, run by Andrea Wallace at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Determinants of Health (SDOH), Digital Health Literacy, Health Services Utilization
- What is being tested?
- Standard Referral to 211, e-SINCERE (Phone Support) and e-SINCERE (Digital Navigation)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2025to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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)
Who cannot join
- Those unable to communicate verbally in English or Spanish
- Those living in nursing facilities, or those who are not otherwise responsible for self-care
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Enhanced Digital Access to Bridge Social Needs and Reduce Health Disparities: 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.
- Conditions
- Social Determinants of Health (SDOH), Digital Health Literacy, Health Services Utilization
- Being tested
- Standard Referral to 211, e-SINCERE (Phone Support), e-SINCERE (Digital Navigation)
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Referral to 211Other
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)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: e-SINCERE (Digital Navigation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after randomization
Secondary outcomes (3)
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.
Measured: Baseline, 2 weeks, 3 months, and 6 months after randomization
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.
Measured: 6 months after randomization
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.
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start8 Aug 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social Determinants of Health (SDOH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrea Wallace
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor-investigator, Andrea Wallace, University of Utah
- Investigators
- Andrea Wallace, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174466
- Sponsor's protocol ID
- 00181891
- Other IDs
- 1R01NR021501-01
- Acronym
- e-SINCERE
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Digital Access to Bridge Social Needs and Reduce Health Disparities: The e-SINCERE Study
- ClinicalTrials.gov ID
- NCT07174466
- Acronym / sponsor ID
- e-SINCERE / 00181891
- Conditions
- Social Determinants of Health (SDOH), Digital Health Literacy, Health Services Utilization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Andrea WallaceUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Control - Standard Referral to 211 | Active comparator | Other: Standard Referral to 211Participants 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. |
| Arm 2: Phone - Bridge Phone to 211 | Experimental | Behavioral: e-SINCERE (Phone Support)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. |
| Arm 3: Navigation - Digital Navigator + 211 | Experimental | Behavioral: e-SINCERE (Digital Navigation)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Community Advisory Board Members
- Health system, governmental, and community service stakeholders
- Able to understand English
- Adult (> 18 years)
- General screening population:
Key exclusion criteria (2 listed)
- Those unable to communicate verbally in English or Spanish
- Those living in nursing facilities, or those who are not otherwise responsible for self-care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Referral to 211Participants 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. | Other | Arm 1: Control - Standard Referral to 211 |
| e-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. | Behavioural | Arm 2: Phone - Bridge Phone to 211 |
| e-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. | Behavioural | Arm 3: Navigation - Digital Navigator + 211 |
Primary outcome
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.
3 secondary outcomes
Health-related quality of life (PROMIS Global Health)
Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization
Emergency department utilization (all-cause ED visits)
Time frame: 6 months after randomization
Digital access stability (phone connectivity)
Time frame: 6 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 42498479Wallace 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Wallace, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Referral to 211, e-SINCERE (Phone Support) and e-SINCERE (Digital Navigation) in people with Social Determinants of Health (SDOH) and Digital Health Literacy, run by Andrea Wallace at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ernest Grigorian, MS (801-585-7194, Ernest.Grigorian@utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful connection to community social services (any service) (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07174466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.