An interventional study of Digital Health Coaching (Patient-Level Intervention) and Practice Facilitation (Clinic-Level Intervention) in Diabetes, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Health services research
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 600 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
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Exclusion Criteria:
Digital coach navigator + Clinic Intervention
Other: Digital Health Coaching (Patient-Level Intervention) · Other: Practice Facilitation (Clinic-Level Intervention)
Usual Care (Patient-Level) + Clinic Usual Care
Digital coach navigator + Clinic Usual Care
Other: Digital Health Coaching (Patient-Level Intervention)
Usual Care (Patient-Level) + Clinic Intervention
Other: Practice Facilitation (Clinic-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.
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).
Change in Patient-Level Hemoglobin A1C
Change in A1C (%) will be determined by subtracting month 3, 6, and 12 A1C values from baseline A1C
Time frame: Baseline, month 3, month 6, and month 12
Change in Patient Portal Use
The average number of patient portal log-ins per month will be obtained from the EHR
Time frame: Baseline, month 3, month 6, and month 12
Digital Literacy
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.
Time frame: Baseline, month 3, month 6, and month 12
Medication Adherence
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.
Time frame: Baseline, month 3, month 6, and month 12
Patient Activation Measure (PAM)
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.
Time frame: Baseline, month 3, month 6, and month 12
Change in Clinic-Wide Blood Pressure (mmHg)
BP readings will be obtained from the EHR
Time frame: Baseline, month 3, month 6, month 12, and month 24
Change in Clinic-Wide Hemoglobin A1C (average)
Hemoglobin A1C readings will be obtained from the EHR
Time frame: Baseline, month 3, month 6, month 12, and month 24
Change in Patient-Level Systolic BP (mmHg)
Changes in mean SBP from baseline, using values from the electronic health record.
Time frame: Baseline, month 3, month 6, month 12
Proportion of Primary care Clinic Visits Completed by Video
This proportion will be ascertained from the electronic health record.
Time frame: Baseline, month 3, month 6, month 12 and month 24
Number of Patient Portal Communications Completed by Primary Care Team Members
The number of patient portal communications will be ascertained from the EHR
Time frame: Baseline, month 3, month 6, month 12, and month 24
Clinic-level Visit Show Rates
Visit show rates for in-person, phone, or telehealth video as obtained from the EHR
Time frame: Baseline, month 3, month 6, month 12, and month 24
Change in Patient-Level urine microalbuminuria (mg/g) among individuals with hypertension and/or diabetes
Urine microalbuminuria (mg/g) will be obtained from the electronic health record.
Time frame: Baseline, month 3, month 6, month 12
Change in Clinic-Wide Urine Albumin-Creatinine Ratio UACR (mg/g) among individuals with hypertension and/or diabetes.
Microalbuminuria values among individuals with hypertension and/or diabetes will be obtained from the EHR.
Time frame: Baseline, month 3, month 6, month 12, and month 24
Plan to share: Yes — The proposed research will include data from approximately 690 participants recruited from primary care clinics in the San Francisco Health Network with uncontrolled diabetes (defined as glycosylated A1c greater than or equal to 8.0%). The final dataset will include self-reported demographic, telehealth engagement, and chronic disease self-management data from self-report, and additional demographic, clinical outcome, and telehealth utilization data from the electronic medical record. The data will be made available in a de-identified format in a .csv or .dta file. In addition to the IPD data set, the ACCTIVATE study team will share the data set, data dictionary, statistical analysis plan, analytic code, and final protocol with amendments
Supporting information: Study protocol, Sap, Analytic code
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University of California, San Francisco