Telehealth Interventions for Diabetes

(ACCTiVATE Trial)

Overseen By Andy Ramirez, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: End-stage condition, Severe mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

600 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on improving telehealth access for managing diabetes and other chronic conditions.

What data supports the effectiveness of the treatment Digital Health Coaching, Digital Health Coaching, Remote Monitoring and Coaching, Telehealth Coaching, Practice Facilitation for diabetes?

Research shows that digital health coaching can significantly improve insulin resistance in patients with type 2 diabetes, making it a promising approach for managing the condition. Additionally, telehealth systems that include health coaching and remote monitoring have been effective in managing chronic diseases by supporting behavior change and overcoming barriers to accessing care. ^{1 2 3 4 5}

Is telehealth coaching safe for humans?

Telehealth coaching, including digital health coaching and remote monitoring, has been used safely in various studies for managing chronic conditions like diabetes and obesity. Participants generally report high satisfaction and no significant safety concerns have been noted in the research. ^{4 6 7 8 9}

How is the telehealth treatment for diabetes different from other treatments?

The telehealth treatment for diabetes is unique because it uses smartphone technology and connected devices for remote blood glucose monitoring, along with virtual coaching and support. This approach allows for personalized, scalable, and effective management of diabetes, especially for under-resourced patients, by focusing on lifestyle and behavioral changes. ^{1 2 4 10 11}

What is the purpose of this trial?

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.

Research Team

Delphine Tuot, MD MAS

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for low-income patients managing chronic conditions like hypertension and diabetes. It aims to improve their access to telehealth services.

Inclusion Criteria

My last A1C level was 8.0% or higher, indicating my diabetes is not well-controlled.

At least 1 visit at a participating SFHN primary care site in the last 24 months

Exclusion Criteria

Visual or hearing impairment that precludes use of telehealth for chronic disease management

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

I do not have a working phone number.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive digital coaching and clinics receive practice facilitation to improve telehealth access and chronic disease management

24 months

Regular virtual and in-person visits as needed

Follow-up

Participants are monitored for clinical outcomes and digital literacy improvements

6 months

Periodic virtual check-ins

Treatment Details

Interventions

• Digital Health Coaching
• Practice Facilitation

Trial Overview 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.

Participant Groups

Group I: Patient Usual Care + Clinic Intervention Experimental Treatment 1 Intervention

Usual Care (Patient-Level) + Clinic Intervention

Group II: Patient Intervention + Clinic Usual Care Experimental Treatment 1 Intervention

Digital coach navigator + Clinic Usual Care

Group III: Patient Intervention + Clinic Intervention Experimental Treatment 2 Interventions

Digital coach navigator + Clinic Intervention

Group IV: Patient Usual Care + Clinic Usual Care Active Control 1 Intervention

Usual Care (Patient-Level) + Clinic Usual Care

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

San Francisco Tech Council

Collaborator

Trials

1

Recruited

600+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

The integration of smart insulin pens and other connected devices into diabetes care can enhance remote monitoring and virtual care, providing a more data-driven clinical practice model.

As healthcare evolves, there is increasing interest from patients and healthcare teams in utilizing these technologies to improve diabetes management and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building a Data-Driven Multiple Daily Insulin Therapy Model Using Smart Insulin Pens. Harbison, R., Hecht, M., MacLeod, J.[2022]

The 12-week Healthy at Home digital health coaching program significantly improved insulin resistance in individuals with type 2 diabetes, showing a reduction in HOMA2-IR scores compared to usual care (p = 0.029).

This pilot study suggests that digital health coaching can be an effective and accessible intervention for under-resourced patients with type 2 diabetes, potentially leading to better diabetes management and clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Health Coaching for Type 2 Diabetes: Randomized Controlled Trial of Healthy at Home. Azelton, KR., Crowley, AP., Vence, N., et al.[2021]

Patients showed high initial acceptance of automated telephonic assessment (ATA) calls for depression monitoring, with 89.6% willing to use them at 6 months, but this willingness decreased to 51.0% by 18 months, indicating a decline in perceived usefulness over time.

Key factors influencing long-term acceptance of ATA calls included perceptions of privacy/security and the ongoing usefulness of the system, suggesting that maintaining patient engagement requires continuous adaptation to their needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Remote Monitoring of Depression: Acceptance Among Low-Income Patients in Diabetes Disease Management. Ramirez, M., Wu, S., Jin, H., et al.[2022]

A review of 13 studies on health coaching combined with telehealth for older adults showed that 10 of these studies reported effective outcomes, such as reduced hospital admissions and improved quality of life.

While telehealth health coaching is a promising method for managing chronic conditions in older adults, most interventions still rely on human coaches, indicating a potential for further development of automated coaching technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Telehealth Technology to Support Health Coaching for Older Adults: Literature Review. Markert, C., Sasangohar, F., Mortazavi, BJ., et al.[2021]

Telehealth dietary interventions significantly improve diet quality, increase fruit and vegetable intake, and reduce dietary sodium intake in adults with chronic diseases, based on a systematic review of 25 studies involving 7384 participants.

These interventions also lead to important clinical improvements, such as reduced systolic blood pressure, lower total cholesterol, decreased triglycerides, and weight loss, highlighting their potential effectiveness in managing chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth methods to deliver dietary interventions in adults with chronic disease: a systematic review and meta-analysis. Kelly, JT., Reidlinger, DP., Hoffmann, TC., et al.[2023]

Diabetes-related apps combined with virtual coaching can significantly improve glycemic control and promote meaningful behavior changes compared to using apps alone, addressing common treatment barriers effectively.

Users of these enhanced apps report high satisfaction and prolonged engagement, suggesting that virtual coaching may be a valuable tool in diabetes education, although further research is needed to explore its long-term effects across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Coaching to Enhance Diabetes Care. Ramchandani, N.[2020]

Remote health coaching (HC) significantly increased the likelihood of participants engaging in moderate to intense physical activity, with a 3.6 times increase at 6 months and a 2.9 times increase at 12 months compared to those not receiving HC.

Participants at higher risk for Type 2 diabetes who received HC lost an average of 2.2 kg more by 12 months and reported greater improvements in their exercise habits, suggesting that HC can effectively support weight loss and lifestyle changes in at-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health coaching and genetic risk testing in primary care: Randomized controlled trial. Wolever, RQ., Yang, Q., Maldonado, CJ., et al.[2022]

In a study involving 763 overweight participants using a mobile phone-based health coaching service for 4 months, participants lost an average of 3.23% of their total body weight, with 28.6% achieving a clinically significant weight loss of 5% or more.

Among participants with high blood pressure, nearly half (49.1%) improved their blood pressure by an entire hypertensive stage after 4 months of coaching, indicating that digital health coaching can effectively support both weight loss and blood pressure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Phone-Based Health Coaching Intervention for Weight Loss and Blood Pressure Reduction in a National Payer Population: A Retrospective Study. Mao, AY., Chen, C., Magana, C., et al.[2019]

In a study involving 501 Medicare participants at risk for diabetes, those who engaged in a program combining digital health and human coaching achieved a significant average weight loss of 7.5% over 12 months.

Participants also showed improvements in glucose control (decreased HbA1c by -0.14%) and total cholesterol levels, along with enhanced self-reported well-being and self-care, indicating the program's effectiveness in reducing chronic disease risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a Digital Health Program With Human Coaching for Diabetes Risk Reduction in a Medicare Population. Castro Sweet, CM., Chiguluri, V., Gumpina, R., et al.[2022]

A systematic review of 37 randomized controlled trials on telehealth dietary interventions revealed that reporting of intervention details was often incomplete, which hinders the ability to replicate and implement these interventions in clinical practice.

Only one trial fully reported all necessary details according to the TIDieR checklist, with critical components like intervention modifications and material descriptions being poorly documented, highlighting a significant gap in the transparency of dietary intervention studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of Telehealth-Delivered Dietary Intervention Trials in Chronic Disease: Systematic Review. Warner, MM., Kelly, JT., Reidlinger, DP., et al.[2023]

Telehealth has the potential to significantly improve diabetes management in the US by utilizing smartphone technology and connected devices for blood glucose monitoring, along with remote coaching.

The study presents a classification system for various virtual diabetes management programs, outlining their strengths and limitations, which can help health systems implement these technologies effectively to enhance population health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A care team-based classification and population management schema for connected diabetes care. Levine, BJ., Close, KL., Gabbay, RA.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Building a Data-Driven Multiple Daily Insulin Therapy Model Using Smart Insulin Pens. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Digital Health Coaching for Type 2 Diabetes: Randomized Controlled Trial of Healthy at Home. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

Automated Remote Monitoring of Depression: Acceptance Among Low-Income Patients in Diabetes Disease Management. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

The Use of Telehealth Technology to Support Health Coaching for Older Adults: Literature Review. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Telehealth methods to deliver dietary interventions in adults with chronic disease: a systematic review and meta-analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Virtual Coaching to Enhance Diabetes Care. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Health coaching and genetic risk testing in primary care: Randomized controlled trial. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

A Mobile Phone-Based Health Coaching Intervention for Weight Loss and Blood Pressure Reduction in a National Payer Population: A Retrospective Study. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Outcomes of a Digital Health Program With Human Coaching for Diabetes Risk Reduction in a Medicare Population. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Reporting of Telehealth-Delivered Dietary Intervention Trials in Chronic Disease: Systematic Review. [2023]

11. England pubmed.ncbi.nlm.nih.gov

A care team-based classification and population management schema for connected diabetes care. [2023]