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Telehealth Interventions for Diabetes (ACCTiVATE Trial)

N/A
Recruiting
Led By Delphine Tuot, MD MAS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 years of age
Have diabetes with a last A1C ≥ 8.0%
Must not have
Lack of any working phone number
Cognitive impairment defined by the inability to restate study goals during the consent process
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 3, month 6, month 12 and month 24
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to help low-income patients with chronic health conditions like hypertension and diabetes access telehealth services more easily. The intervention involves support at both the clinic level and individual level through digital health coaching.

Who is the study for?
This trial is for low-income patients managing chronic conditions like hypertension and diabetes. It aims to improve their access to telehealth services.
What is being tested?
The study tests a multi-level intervention that includes practice facilitation at the clinic level and digital health coaching for patients, focusing on enhancing telehealth use.
What are the potential side effects?
Since this trial involves non-medical interventions like practice facilitation and digital health coaching, traditional medication side effects are not applicable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My last A1C level was 8.0% or higher, indicating my diabetes is not well-controlled.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a working phone number.
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I can understand and repeat the study goals during the consent process.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 3, month 6, month 12 and month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 3, month 6, month 12 and month 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Patient Portal Use
Change in Patient-Level Hemoglobin A1C
Secondary study objectives
Change in Clinic-Wide Blood Pressure (mmHg)
Change in Clinic-Wide Hemoglobin A1C (average)
Change in Clinic-Wide Urine Albumin-Creatinine Ratio UACR (mg/g) among individuals with hypertension and/or diabetes.
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Patient Usual Care + Clinic InterventionExperimental Treatment1 Intervention
Usual Care (Patient-Level) + Clinic Intervention
Group II: Patient Intervention + Clinic Usual CareExperimental Treatment1 Intervention
Digital coach navigator + Clinic Usual Care
Group III: Patient Intervention + Clinic InterventionExperimental Treatment2 Interventions
Digital coach navigator + Clinic Intervention
Group IV: Patient Usual Care + Clinic Usual CareActive Control1 Intervention
Usual Care (Patient-Level) + Clinic Usual Care

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,350 Total Patients Enrolled
16 Trials studying Diabetes
161,447 Patients Enrolled for Diabetes
San Francisco Tech CouncilUNKNOWN
National Institute on Minority Health and Health Disparities (NIMHD)NIH
444 Previous Clinical Trials
1,412,911 Total Patients Enrolled
15 Trials studying Diabetes
15,363 Patients Enrolled for Diabetes
Delphine Tuot, MD MASPrincipal InvestigatorUniversity of California, San Francisco
~400 spots leftby Sep 2028