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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to help low-income patients with diabetes manage their condition through telehealth (remote healthcare services). It focuses on digital health coaching for patients and practice facilitation for clinics to determine if these tools improve care. Participants will receive either digital health coaching, extra clinic support, or their usual care. Suitable candidates include those with diabetes and high A1C levels (a common blood test showing average blood sugar levels over the past three months) who have visited a participating clinic at least once in the last two years. As an unphased trial, this study offers a unique opportunity to contribute to innovative healthcare solutions and potentially enhance diabetes management for many.

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 prior data suggests that these telehealth interventions are safe for patients with chronic conditions?

Research has shown that digital health coaching is generally safe for managing diabetes. One study found it helped control blood sugar without serious side effects. Another study demonstrated that digital coaching aided in weight loss and improved diabetes management. These studies reported no major safety concerns.

Research also indicates that practice facilitation effectively improves diabetes care in clinics. Studies have found it helps clinics adhere to care guidelines, enhancing patient care. No significant safety issues were noted in these studies either.

Overall, both digital health coaching and practice facilitation are well-tolerated and have shown positive results in managing diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these telehealth interventions for diabetes because they offer a fresh approach to managing the condition. Unlike traditional in-person visits and medication management, these interventions leverage digital health coaching and practice facilitation to provide personalized, ongoing support. The digital coach navigator is designed to keep patients engaged and on track with their health goals, potentially improving outcomes by making diabetes care more accessible and consistent. This approach could lead to better patient involvement in their own care, which is crucial for managing a chronic condition like diabetes.

What evidence suggests that this trial's interventions could be effective for diabetes?

This trial will evaluate the effectiveness of different telehealth interventions for diabetes. Research has shown that digital health coaching, one of the interventions in this trial, can help manage type 2 diabetes. One study found that this method reduced health-related stress, improved mood, and increased understanding of digital health tools. Another study demonstrated that digital health coaching boosted confidence in managing health, encouraged healthier eating, and increased patient engagement in their care.

For practice facilitation, another intervention in this trial, research indicates it can enhance diabetes care. It was found to improve the quality of care and diabetes management in primary care settings. This method also led to significant and lasting improvements in care delivery. Both digital health coaching and practice facilitation appear promising for helping patients manage diabetes effectively. ^{1 2 3 6 7}

Who Is on the Research Team?

Delphine Tuot, MD MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12018868/

Health Coaching and Its Impact in the Remote ... Trials that evaluated the role of health coaching in the remote monitoring of patients with T2DM have shown promising results. For example, the study by Bollyky ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0197457225003520

Effectiveness of a digital health coaching self-management ... Results. Group-by-time interactions showed significant improvements in health distress, depression, and digital health literacy in the intervention ...

3. frontiersin.org frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2021.764735/full

Digital Health Coaching for Type 2 Diabetes: Randomized ... This pilot study addresses a research gap in finding effective and accessible behavioral interventions for under-resourced individuals with T2DM.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2798389

Health Coaching for Patient-Family Dyads to Improve ... In this randomized clinical trial with 239 patient-supporter dyads, CO-IMPACT improved patient activation, diabetes self-efficacy, and healthy eating.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03312764

Preventing Diabetes With Digital Health and Coaching While non-randomized trial data demonstrate that an online digital program was successful for producing meaningful weight loss and improved glucose control, the ...

6. ama-assn.org ama-assn.org/practice-management/digital-health/telehealth-scenario-remote-patient-monitoring-rpm-diabetes

Remote patient monitoring (RPM) for diabetes management Improve clinical outcomes for patients with diabetes. Program impact on health care value streams. Clinical quality and safety outcomes. Relevant measures.

7. mhealth.jmir.org mhealth.jmir.org/2024/1/e50356

Real-World Outcomes of a Digital Behavioral Coaching ... This study aimed to retrospectively evaluate the impact of a digital behavioral coaching program on year-to-year changes in employee health status in a cohort ...