DiabetesACCTiVATENCT06598436
Achieving Chronic Care equiTy by leVeraging the Telehealth Ecosystem
A study testing Digital Health Coaching (Patient-Level Intervention) and Practice Facilitation (Clinic-Level Intervention) in people with Diabetes, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Digital Health Coaching (Patient-Level Intervention) and Practice Facilitation (Clinic-Level Intervention)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2024to Sep 2028
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
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
Zuckerberg San Francisco General Hospital (ZSFG) & SF Department of Public Health (DPH)
San Francisco, California, 94110
Andy Ramirez, BS, 415-562-4509, Andy.Ramirez@ucsf.edu
Alexandra Velasquez, MS, 415-562-4509, Alexandra.Velasquez@ucsf.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Diabetes
- Being tested
- Digital Health Coaching (Patient-Level Intervention), Practice Facilitation (Clinic-Level Intervention)
- 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)
- Medical subject headings
- Diabetes Mellitus, Renal Insufficiency, Chronic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Patient Intervention + Clinic Intervention | Experimental | Digital coach navigator + Clinic Intervention Receives: Other: Digital Health Coaching (Patient-Level Intervention); Other: Practice Facilitation (Clinic-Level Intervention) |
| Patient Usual Care + Clinic Usual Care | No intervention | Usual Care (Patient-Level) + Clinic Usual Care |
| Patient Intervention + Clinic Usual Care | Experimental | Digital coach navigator + Clinic Usual Care Receives: Other: Digital Health Coaching (Patient-Level Intervention) |
| Patient Usual Care + Clinic Intervention | Experimental | Usual Care (Patient-Level) + Clinic Intervention Receives: Other: Practice Facilitation (Clinic-Level Intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-Level Hemoglobin A1C
Change in A1C (%) will be determined by subtracting month 3, 6, and 12 A1C values from baseline A1C
Measured: 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
Measured: Baseline, month 3, month 6, and month 12
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, month 3, month 6, and month 12
Change in Clinic-Wide Blood Pressure (mmHg)
BP readings will be obtained from the EHR
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline, month 3, month 6, month 12, and month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Nov 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- The investigators propose a prospective, multilevel, nonblinded 2x2 randomized controlled trial to determine the effectiveness of a clinic-level intervention and a patient-level intervention, as well as the potential synergistic impact of both interventions on process outcomes and clinical measures of diabetes control. Five of the 11 participating clinics will be randomized to receive practice facilitation for 24 months. After implementing the clinic-level intervention, the investigators will begin recruiting/randomizing eligible patients in a 1:2 ratio to receive tailored digital coaching (n=200) or usual care (n=400) for 3 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Tech Council, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Delphine Tuot, MD MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598436
- Sponsor's protocol ID
- 23-40207
- Other IDs
- R01MD019042
- Acronym
- ACCTiVATE
- Status last verified
- Jan 2026
- First submitted
- 13 Sep 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Patrick K, Norman GJ, Davila EP, Calfas KJ, Raab F, Gottschalk M, Sallis JF, Godbole S, Covin JR. Outcomes of a 12-month technology-based intervention to promote weight loss in adolescents at risk for type 2 diabetes. J Diabetes Sci Technol. 2013 May 1;7(3):759-70. doi: 10.1177/193229681300700322.
PubMed 23759410Grossman LV, Masterson Creber RM, Benda NC, Wright D, Vawdrey DK, Ancker JS. Interventions to increase patient portal use in vulnerable populations: a systematic review. J Am Med Inform Assoc. 2019 Aug 1;26(8-9):855-870. doi: 10.1093/jamia/ocz023.
PubMed 30958532Irizarry T, Shoemake J, Nilsen ML, Czaja S, Beach S, DeVito Dabbs A. Patient Portals as a Tool for Health Care Engagement: A Mixed-Method Study of Older Adults With Varying Levels of Health Literacy and Prior Patient Portal Use. J Med Internet Res. 2017 Mar 30;19(3):e99. doi: 10.2196/jmir.7099.
PubMed 28360022Taha J, Sharit J, Czaja SJ. The impact of numeracy ability and technology skills on older adults' performance of health management tasks using a patient portal. J Appl Gerontol. 2014 Jun;33(4):416-36. doi: 10.1177/0733464812447283. Epub 2012 Jun 4.
PubMed 24781964Sarkar U, Karter AJ, Liu JY, Adler NE, Nguyen R, Lopez A, Schillinger D. Social disparities in internet patient portal use in diabetes: evidence that the digital divide extends beyond access. J Am Med Inform Assoc. 2011 May 1;18(3):318-21. doi: 10.1136/jamia.2010.006015. Epub 2011 Jan 24.
PubMed 21262921Wallace LS, Angier H, Huguet N, Gaudino JA, Krist A, Dearing M, Killerby M, Marino M, DeVoe JE. Patterns of Electronic Portal Use among Vulnerable Patients in a Nationwide Practice-based Research Network: From the OCHIN Practice-based Research Network (PBRN). J Am Board Fam Med. 2016 Sep-Oct;29(5):592-603. doi: 10.3122/jabfm.2016.05.160046.
PubMed 27613792Sarkar U, Karter AJ, Liu JY, Adler NE, Nguyen R, Lopez A, Schillinger D. The literacy divide: health literacy and the use of an internet-based patient portal in an integrated health system-results from the diabetes study of northern California (DISTANCE). J Health Commun. 2010;15 Suppl 2(Suppl 2):183-96. doi: 10.1080/10810730.2010.499988.
PubMed 20845203Lyles CR, Tieu L, Sarkar U, Kiyoi S, Sadasivaiah S, Hoskote M, Ratanawongsa N, Schillinger D. A Randomized Trial to Train Vulnerable Primary Care Patients to Use a Patient Portal. J Am Board Fam Med. 2019 Mar-Apr;32(2):248-258. doi: 10.3122/jabfm.2019.02.180263.
PubMed 30850461Ramirez V, Johnson E, Gonzalez C, Ramirez V, Rubino B, Rossetti G. Assessing the Use of Mobile Health Technology by Patients: An Observational Study in Primary Care Clinics. JMIR Mhealth Uhealth. 2016 Apr 19;4(2):e41. doi: 10.2196/mhealth.4928.
PubMed 27095507Schickedanz A, Huang D, Lopez A, Cheung E, Lyles CR, Bodenheimer T, Sarkar U. Access, interest, and attitudes toward electronic communication for health care among patients in the medical safety net. J Gen Intern Med. 2013 Jul;28(7):914-20. doi: 10.1007/s11606-012-2329-5. Epub 2013 Feb 20.
PubMed 23423453Nishii A, Campos-Castillo C, Anthony D. Disparities in patient portal access by US adults before and during the COVID-19 pandemic. JAMIA Open. 2022 Dec 16;5(4):ooac104. doi: 10.1093/jamiaopen/ooac104. eCollection 2022 Dec.
PubMed 36540762Barbosa W, Zhou K, Waddell E, Myers T, Dorsey ER. Improving Access to Care: Telemedicine Across Medical Domains. Annu Rev Public Health. 2021 Apr 1;42:463-481. doi: 10.1146/annurev-publhealth-090519-093711.
PubMed 33798406Meng YY, Diamant A, Jones J, Lin W, Chen X, Wu SH, Pourat N, Roby D, Kominski GF. Racial and Ethnic Disparities in Diabetes Care and Impact of Vendor-Based Disease Management Programs. Diabetes Care. 2016 May;39(5):743-9. doi: 10.2337/dc15-1323. Epub 2016 Mar 10.
PubMed 26965718Wisniewski H, Gorrindo T, Rauseo-Ricupero N, Hilty D, Torous J. The Role of Digital Navigators in Promoting Clinical Care and Technology Integration into Practice. Digit Biomark. 2020 Nov 26;4(Suppl 1):119-135. doi: 10.1159/000510144. eCollection 2020 Winter.
PubMed 33442585Samuels-Kalow M, Jaffe T, Zachrison K. Digital disparities: designing telemedicine systems with a health equity aim. Emerg Med J. 2021 Jun;38(6):474-476. doi: 10.1136/emermed-2020-210896. Epub 2021 Mar 4.
PubMed 33674277
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Chronic Care equiTy by leVeraging the Telehealth Ecosystem
- ClinicalTrials.gov ID
- NCT06598436
- Acronym / sponsor ID
- ACCTiVATE / 23-40207
- Conditions
- Diabetes
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco Tech Council, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 19 Sep 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The investigators propose a prospective, multilevel, nonblinded 2x2 randomized controlled trial to determine the effectiveness of a clinic-level intervention and a patient-level intervention, as well as the potential synergistic impact of both interventions on process outcomes and clinical measures of diabetes control. Five of the 11 participating clinics will be randomized to receive practice facilitation for 24 months. After implementing the clinic-level intervention, the investigators will begin recruiting/randomizing eligible patients in a 1:2 ratio to receive tailored digital coaching (n=200) or usual care (n=400) for 3 months.
| Arm | Type | Receives |
|---|---|---|
| Patient Intervention + Clinic Intervention | Experimental | Other: Digital Health Coaching (Patient-Level Intervention), Other: Practice Facilitation (Clinic-Level Intervention)Digital coach navigator + Clinic Intervention |
| Patient Usual Care + Clinic Usual Care | No intervention | –Usual Care (Patient-Level) + Clinic Usual Care |
| Patient Intervention + Clinic Usual Care | Experimental | Other: Digital Health Coaching (Patient-Level Intervention)Digital coach navigator + Clinic Usual Care |
| Patient Usual Care + Clinic Intervention | Experimental | Other: Practice Facilitation (Clinic-Level Intervention)Usual Care (Patient-Level) + Clinic Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| 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. | Other | Patient Intervention + Clinic Intervention, Patient Intervention + Clinic Usual Care |
| 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). | Other | Patient Intervention + Clinic Intervention, Patient Usual Care + Clinic Intervention |
Primary outcome
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
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
11 secondary outcomes
Digital Literacy
Time frame: Baseline, month 3, month 6, and month 12
Medication Adherence
Time frame: Baseline, month 3, month 6, and month 12
Patient Activation Measure (PAM)
Time frame: Baseline, month 3, month 6, and month 12
Change in Clinic-Wide Blood Pressure (mmHg)
Time frame: Baseline, month 3, month 6, month 12, and month 24
Change in Clinic-Wide Hemoglobin A1C (average)
Time frame: Baseline, month 3, month 6, month 12, and month 24
Change in Patient-Level Systolic BP (mmHg)
Time frame: Baseline, month 3, month 6, month 12
Proportion of Primary care Clinic Visits Completed by Video
Time frame: Baseline, month 3, month 6, month 12 and month 24
Number of Patient Portal Communications Completed by Primary Care Team Members
Time frame: Baseline, month 3, month 6, month 12, and month 24
Clinic-level Visit Show Rates
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
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.
Time frame: Baseline, month 3, month 6, month 12, and month 24
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 6 Jan 2026.
- Background: PubMed 23759410Patrick K, Norman GJ, Davila EP, Calfas KJ, Raab F, Gottschalk M, Sallis JF, Godbole S, Covin JR. Outcomes of a 12-month technology-based intervention to promote weight loss in adolescents at risk for type 2 diabetes. J Diabetes Sci Technol. 2013 May 1;7(3):759-70. doi: 10.1177/193229681300700322.
- Background: PubMed 30958532Grossman LV, Masterson Creber RM, Benda NC, Wright D, Vawdrey DK, Ancker JS. Interventions to increase patient portal use in vulnerable populations: a systematic review. J Am Med Inform Assoc. 2019 Aug 1;26(8-9):855-870. doi: 10.1093/jamia/ocz023.
- Background: PubMed 28360022Irizarry T, Shoemake J, Nilsen ML, Czaja S, Beach S, DeVito Dabbs A. Patient Portals as a Tool for Health Care Engagement: A Mixed-Method Study of Older Adults With Varying Levels of Health Literacy and Prior Patient Portal Use. J Med Internet Res. 2017 Mar 30;19(3):e99. doi: 10.2196/jmir.7099.
- Background: PubMed 24781964Taha J, Sharit J, Czaja SJ. The impact of numeracy ability and technology skills on older adults' performance of health management tasks using a patient portal. J Appl Gerontol. 2014 Jun;33(4):416-36. doi: 10.1177/0733464812447283. Epub 2012 Jun 4.
- Background: PubMed 21262921Sarkar U, Karter AJ, Liu JY, Adler NE, Nguyen R, Lopez A, Schillinger D. Social disparities in internet patient portal use in diabetes: evidence that the digital divide extends beyond access. J Am Med Inform Assoc. 2011 May 1;18(3):318-21. doi: 10.1136/jamia.2010.006015. Epub 2011 Jan 24.
- Background: PubMed 27613792Wallace LS, Angier H, Huguet N, Gaudino JA, Krist A, Dearing M, Killerby M, Marino M, DeVoe JE. Patterns of Electronic Portal Use among Vulnerable Patients in a Nationwide Practice-based Research Network: From the OCHIN Practice-based Research Network (PBRN). J Am Board Fam Med. 2016 Sep-Oct;29(5):592-603. doi: 10.3122/jabfm.2016.05.160046.
- Background: PubMed 20845203Sarkar U, Karter AJ, Liu JY, Adler NE, Nguyen R, Lopez A, Schillinger D. The literacy divide: health literacy and the use of an internet-based patient portal in an integrated health system-results from the diabetes study of northern California (DISTANCE). J Health Commun. 2010;15 Suppl 2(Suppl 2):183-96. doi: 10.1080/10810730.2010.499988.
- Background: PubMed 30850461Lyles CR, Tieu L, Sarkar U, Kiyoi S, Sadasivaiah S, Hoskote M, Ratanawongsa N, Schillinger D. A Randomized Trial to Train Vulnerable Primary Care Patients to Use a Patient Portal. J Am Board Fam Med. 2019 Mar-Apr;32(2):248-258. doi: 10.3122/jabfm.2019.02.180263.
- Background: PubMed 27095507Ramirez V, Johnson E, Gonzalez C, Ramirez V, Rubino B, Rossetti G. Assessing the Use of Mobile Health Technology by Patients: An Observational Study in Primary Care Clinics. JMIR Mhealth Uhealth. 2016 Apr 19;4(2):e41. doi: 10.2196/mhealth.4928.
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- Individual participant dataSharing planned: 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
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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.
Delphine Tuot, MD MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health Coaching (Patient-Level Intervention) and Practice Facilitation (Clinic-Level Intervention) in people with Diabetes, run by University of California, San Francisco 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 4 inclusion and 6 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 6 Jan 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 Andy Ramirez, BS (415-562-4509, Andy.Ramirez@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient-Level Hemoglobin A1C (time frame: Baseline, month 3, month 6, and month 12). The study lists 2 primary outcomes in all. 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 NCT06598436, which also lists 23 linked publications.
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 6 Jan 2026.