Recruiting

Telehealth Ecosystem

Sponsor:

UCLA

Code:

NCT06598436

Conditions

Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital Health Coaching (Patient-Level Intervention)

Practice Facilitation (Clinic-Level Intervention)

Study Details

Brief summary:

This study examines the impact of a multi-level intervention aiming to improve telehealth access for low-income patients managing chronic health conditions, such as hypertension and diabetes. The multi-level intervention includes clinic-level practice facilitation and patient-level digital health coaching.

Conditions

Diabetes

Study ID

NCT06598436

Start date

Nov 4, 2024

Status verified date

Jan, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥ 18 years of age
  • English or Spanish-Speaking
  • Have uncontrolled diabetes defined as a listed diagnosis of diabetes with a recorded A1C ≥ 8.0% in the past two years or have uncontrolled HTN defined as a listed diagnosis of HTN and last recorded documented SBP >140 mmHg
  • At least 2 visits at a participating SFHN primary care site in the last 24 months

Exclusion Criteria:

  • Higher than average digital literacy, defined as an Digital Healthcare Literacy Scale (DHLS) score greater than 10, as determined prior to the baseline study visit; these patients may not benefit from a digital coaching intervention.
  • Presence of co-morbid conditions that would make it inappropriate to focus on telehealth chronic disease management. Conditions may include: end-stage or terminal condition with limited life expectancy and severe mental illness.
  • Lack of any working phone number
  • Visual or hearing impairment that precludes use of telehealth for chronic disease management
  • Cognitive impairment defined by the inability to restate study goals during the consent process
  • Pregnant

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Patient Intervention + Clinic Intervention

Digital coach navigator + Clinic Intervention

no intervention: Patient Usual Care + Clinic Usual Care

Usual Care (Patient-Level) + Clinic Usual Care

experimental: Patient Intervention + Clinic Usual Care

Digital coach navigator + Clinic Usual Care

experimental: Patient Usual Care + Clinic Intervention

Usual Care (Patient-Level) + Clinic Intervention

Interventions

Digital Health Coaching (Patient-Level Intervention)

The patient-level intervention combines the role of digital health navigator and chronic disease health coach to facilitate access to devices and broadband, offer digital skills training, and provide chronic disease health coaching focused on telehealth modalities.

Practice Facilitation (Clinic-Level Intervention)

The clinic-level intervention includes primary care clinic support through practice facilitation that empowers team members to address racial/ethnic disparities in telehealth use through consistent review of telehealth equity data and input from clinic-specific Patient Advisory Councils (PACs).

Primary outcome measure

  • Change in Patient-Level Hemoglobin A1C [ Time Frame: Baseline, month 3, month 6, and month 12 ]
  • Change in Patient Portal Use [ Time Frame: Baseline, month 3, month 6, and month 12 ]

Central Contacts and Locations

Central contacts

Andy Ramirez, BS

415-562-4509Andy.Ramirez@ucsf.edu

Alexandra Velasquez, MS

415-562-4509ACCTIVATEStudy@ucsf.edu

Locations

Zuckerberg San Francisco General Hospital (ZSFG) & SF Department of Public Health (DPH)

Recruiting

San Francisco, California, United States, 94110

Contacts

Andy Ramirez, BS

415-562-4509Andy.Ramirez@ucsf.edu

Alexandra Velasquez, MS

415-562-4509Alexandra.Velasquez@ucsf.edu

Principal Investigator:

Delphine Tuot, MD MAS

More Information

Sponsor

University of California, San Francisco

Last update posted

Jan 6, 2026

Last verified

Jan, 2026

Keywords

  • Adverse Event
  • Blood Pressure
  • Community Advisory Board (CAB)
  • Chronic Kidney Disease (CKD)
  • Clinic-level Intervention
  • Clinical Research Coordinator (CRC)
  • Cardiovascular Disease
  • Digital Coach Navigator
  • Federally Qualified Health Center (FQHC)
  • Good Clinical Practice
  • Health Care Systems
  • Health Insurance Portability and Accountability Act of 1996
  • Hemoglobin A1C
  • Informed Consent Form (ICF)
  • Institutional Review Board (IRB)
  • Library
  • National Institutes of Health (NIH)
  • Randomized Control Trial (RCT)
  • National Institute of Minority Health and Health Disparities (NIHMD)
  • Patient Advisory Council (PAC)
  • Patient-level Intervention
  • Principal Investigator (PI)
  • Socioeconomic Status
  • San Francisco Health Network (SFHN)
  • Systolic Blood Pressure (SBP)
  • Telehealth
  • Telemedicine
  • University of California, San Francisco (UCSF)
  • Zuckerberg San Francisco General Hospital (ZSFG)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-01-06.