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NCT Number: NCT06598436

Achieving Chronic Care equiTy by leVeraging the Telehealth Ecosystem

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

San Francisco, California, 94110, United States

Location status: Recruiting

Location contact

Alexandra Velasquez, MS

CONTACT

[email protected]

415-562-4509

Andy Ramirez, BS

CONTACT

[email protected]

415-562-4509

Anjana Sharma, MD

SUB_INVESTIGATOR

Delphine Tuot, MD MAS

PRINCIPAL_INVESTIGATOR

About this study

ACCTIVATE is a multi-level intervention (including practice facilitation and patient digital coaching) that aims to tackle patient-level and clinic-level barriers to increase the equitable use of telehealth tools for chronic disease management. Direct patient support via digital coaching can meet the needs of patients who have been left behind in the digital divide. For those with reduced digital literacy and low access to smartphones and broadband, this resource can increase their confidence in using digital technologies and engaging in virtual care. Additionally, primary care clinic support through practice facilitation can empower team members to address racial/ethnic disparities in telehealth use through equitable screening/offering of digital technologies, resources to prepare patients for virtual chronic disease management, and consistent review of telehealth equity data. The investigators hypothesize that this multi-level intervention will improve patient control of chronic health conditions (i.e., glycosylated hemoglobin) as well as digital literacy, while also increasing patient and clinician engagement with patient portals, telehealth video visits and remote monitoring.

Aim 1: Assess the impact of the multi-level intervention on clinical outcomes at 3, 6, 12, and 24 months. Our working hypotheses are that patients randomized to receive digital coaching (vs. usual care) will experience a greater change in mean glycosylated hemoglobin A1C, both overall and among Black and Latinx patients. Clinics randomized to practice facilitation (vs. usual care) will experience a greater clinic-level change in mean glycosylated hemoglobin A1C, both overall and among their Black and Latinx populations.

Aim 2: Assess the impact of the multi-level intervention on process outcomes related to digital literacy, engagement in care, and health IT utilization at 3, 6, 12, and 24 months. The investigators hypothesize that randomization to digital coaching (vs. usual care) will increase patient portal use, digital literacy, and visit show rate, overall and among Black and Latinx patients. Randomization to practice facilitation (vs. usual care) will increase clinic-level use of telehealth video visits and patient-portal communication, overall and with Black and Latinx patients.

Aim 3: Conduct a mixed methods evaluation of intervention implementation outcomes. Quantitative engagement data, direct observations of intervention sessions, and stakeholder interviews will characterize implementation outcomes and factors necessary to integrate the multi-level intervention into clinical operations, applying the RE-AIM implementation science framework.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Digital Health Coaching (Patient-Level Intervention)

Other

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)

Other

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 outcomes

  1. Change in Patient-Level Hemoglobin A1C

    Time frame: Baseline, month 3, month 6, and month 12

    Change in A1C (%) will be determined by subtracting month 3, 6, and 12 A1C values from baseline A1C

  2. Change in Patient Portal Use

    Time frame: Baseline, month 3, month 6, and month 12

    The average number of patient portal log-ins per month will be obtained from the EHR

Secondary outcomes

  1. Digital Literacy

    Time frame: Baseline, month 3, month 6, and month 12

    Digital literacy will be ascertained with the Digital Healthcare Literacy Scale (DHLS). The DHLS is an 3-item scale that uses a 5-point Likert scale. Scores range from 0 to 12, with higher scores indicating higher digital health care literacy.

    Ongoing digital literacy will be ascertained with the Digital Equity Screening Tool Scale (DEST). The DEST is an 5-item scale that uses a 5-point Likert scale.

  2. Medication Adherence

    Time frame: Baseline, month 3, month 6, and month 12

    Medication adherence will be ascertained by the eight-item Morisky Medication Adherence Scale (MMAS-8). The scales score ranges from 0 to 8, with higher scores indicating greater medication adherence.

    High adherence: A score of 8 Medium adherence: A score of 6-8 Low adherence: A score of 6 and below.

  3. Patient Activation Measure (PAM)

    Time frame: Baseline, month 3, month 6, and month 12

    Patient activation will be measured by the Patient Activation Measure (PAM). The PAM-13 consists of 13 items on a 4-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree, 0 = undecided). Item scores are summed to a raw score resulting in theoretical values between 13 and 52, with higher scores indicating higher patient activation.

  4. Change in Clinic-Wide Blood Pressure (mmHg)

    Time frame: Baseline, month 3, month 6, month 12, and month 24

    BP readings will be obtained from the EHR

  5. Change in Clinic-Wide Hemoglobin A1C (average)

    Time frame: Baseline, month 3, month 6, month 12, and month 24

    Hemoglobin A1C readings will be obtained from the EHR

  6. Change in Patient-Level Systolic BP (mmHg)

    Time frame: Baseline, month 3, month 6, month 12

    Changes in mean SBP from baseline, using values from the electronic health record.

  7. Proportion of Primary care Clinic Visits Completed by Video

    Time frame: Baseline, month 3, month 6, month 12 and month 24

    This proportion will be ascertained from the electronic health record.

  8. Number of Patient Portal Communications Completed by Primary Care Team Members

    Time frame: Baseline, month 3, month 6, month 12, and month 24

    The number of patient portal communications will be ascertained from the EHR

  9. Clinic-level Visit Show Rates

    Time frame: Baseline, month 3, month 6, month 12, and month 24

    Visit show rates for in-person, phone, or telehealth video as obtained from the EHR

  10. Change in Patient-Level urine microalbuminuria (mg/g) among individuals with hypertension and/or diabetes

    Time frame: Baseline, month 3, month 6, month 12

    Urine microalbuminuria (mg/g) will be obtained from the electronic health record.

  11. Change in Clinic-Wide Urine Albumin-Creatinine Ratio UACR (mg/g) among individuals with hypertension and/or diabetes.

    Time frame: Baseline, month 3, month 6, month 12, and month 24

    Microalbuminuria values among individuals with hypertension and/or diabetes will be obtained from the EHR.

Study contacts

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

Alexandra Velasquez, MS

CONTACT

[email protected]

415-562-4509

Andy Ramirez, BS

CONTACT

[email protected]

415-562-4509

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • San Francisco Tech Council

Registry information

Acronym: ACCTiVATE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Jan 6, 2026

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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