Telehealth Coaching for Type 2 Diabetes and High Blood Pressure

Overseen By Samara Khan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Pregnancy, Type 1 diabetes, others

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

Compensation: Varies

Number of Visits: 5

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help South Asian individuals manage type 2 diabetes and high blood pressure through telehealth coaching by community health workers. The researchers aim to determine if this support, known as the Integrated CHW Intervention, is more effective than regular doctor visits alone. Participants will either continue with their usual care or receive additional online coaching sessions. Ideal participants are South Asian adults with both diabetes and high blood pressure that have not been controlled in the past six months. As an unphased trial, this study allows participants to contribute to innovative healthcare solutions tailored to their community.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this telehealth coaching intervention is safe for South Asian patients with type 2 diabetes and high blood pressure?

Research has shown that community health workers (CHWs) effectively help people manage conditions like high blood pressure and type 2 diabetes. Many studies have found that CHWs assist individuals in adopting healthier habits, leading to better control of these conditions.

For instance, evidence from past programs indicates that CHWs can help lower blood pressure in people with diabetes. These findings suggest that this approach is well-received and poses no significant safety risks to participants. Studies have reported no major harmful events, meaning participants generally do not experience negative side effects from the program itself.

Overall, the CHW program is considered safe for those looking to manage diabetes and high blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of telehealth coaching with Community Health Workers (CHWs) for managing Type 2 diabetes and high blood pressure because it offers a personalized and accessible approach. Unlike traditional treatments that often rely solely on medication and in-person doctor visits, this method uses virtual meetings and educational sessions to empower patients directly in their own environment. By focusing on patient education and support through technology, this approach aims to enhance self-management and improve health outcomes, making it a promising complement or alternative to standard care.

What evidence suggests that this telehealth coaching intervention is effective for managing type 2 diabetes and high blood pressure?

Research has shown that community health worker (CHW) programs can help manage type 2 diabetes and high blood pressure, especially in underserved communities. For example, one study found that CHW-led health coaching helped control blood pressure in South Asian Americans in New York City. Another review found that these programs also helped manage blood sugar levels, which is important for diabetes care. In this trial, participants in the Community Health Workers (CHW) treatment group will receive a CHW-led telehealth program, which could benefit South Asian patients with both high blood pressure and diabetes. Meanwhile, the control group will complete only the first educational session and receive usual care from their primary care physician. ^{1 2 6 7 8}

Who Is on the Research Team?

Nadia Islam, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for South Asian individuals with both type 2 diabetes and high blood pressure. It's designed to see if health coaching over telehealth can help manage these conditions better than the usual care.

Inclusion Criteria

Identified as of South Asian ethnicity

Uncontrolled BP reading (>130/80mmHg) in the last 6 months

I am 21 years old or older.

Exclusion Criteria

I have type 1 diabetes or diabetes caused by another condition.

I cannot do physical activities by myself.

I am younger than 21 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the CHW treatment group receive a 6-month telehealth intervention with 5 educational sessions and 2 one-on-one virtual meetings

6 months

5 educational sessions, 2 virtual meetings

Control

Control participants receive usual care from their primary care physician during the first 12 months

12 months

Follow-up

Participants are monitored for changes in HbA1c, BMI, and blood pressure at 6 and 12 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CHW Session 1 Only
• Integrated CHW Intervention

Trial Overview

The study compares a culturally tailored telehealth program led by community health workers (CHW) against regular treatment. The program aims to improve hypertension control in patients, and its success will be measured using specific research frameworks.

How Is the Trial Designed?

Group I: Community Health Workers (CHW) treatment group Experimental Treatment 1 Intervention

There is a 6-month intervention period immediately following recruitment. Participants enrolled in the intervention will complete 5 educational sessions and attend 2 one-on-one virtual meetings.

Group II: Control group Active Control 1 Intervention

The control participants will complete only the first educational session. The control arm will receive usual care from their primary care physician (PCP) during the first 12 months of data collection. After 12 months they will be invited to attend remaining group sessions.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

Clinicians are generally supportive of involving trained nonclinician health coaches in managing hypertension, believing that this delegation can improve medication adherence and patient outcomes.

The study highlights the importance of effective communication between coaches and clinicians, as well as the need for ongoing health coaching to maintain blood pressure control, especially in low-income patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delegating responsibility from clinicians to nonprofessional personnel: the example of hypertension control. Margolius, D., Wong, J., Goldman, ML., et al.[2012]

A randomized controlled trial involving 1,665 Medicare recipients with diabetes demonstrated that telemedicine case management significantly improved key health metrics, including hemoglobin A1c, LDL cholesterol, and blood pressure over a 5-year period.

Despite the improvements in health outcomes, the study found no significant difference in mortality rates between the telemedicine and usual care groups, suggesting that while telemedicine is effective for managing diabetes, it does not impact overall survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study. Shea, S., Weinstock, RS., Teresi, JA., et al.[2022]

Nonadherence to antihypertensive medications leads to uncontrolled high blood pressure and negative health outcomes, highlighting the need for improved strategies to enhance medication adherence.

Four proposed strategies to improve adherence include focusing on clinical outcomes, empowering patients, developing proactive care teams, and advocating for health policy reform, which are essential for better management of hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence and persistence with taking medication to control high blood pressure. Hill, MN., Miller, NH., Degeest, S., et al.[2011]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11549830/

Addressing Hypertension and Diabetes through Community ...

Here we describe the rationale and study design for a hybrid type 2 randomized controlled trial to test the implementation and effectiveness of ...

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Implementation Evaluation of a Community Health Worker ...

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Integrating Community Health Workers into ...

A CHW-led health coaching intervention was effective in achieving BP control among South Asian Americans in New York City primary care practices.

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Evaluating the effectiveness of community health worker ...

In the systematic review reported here, we aimed to evaluate the independent effectiveness of CHW interventions on the control of HbA1c levels ...

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clinicaltrials.gov/study/NCT06230835

Community Health Worker Led Hypertension Prevention ...

Investigators will assess these outcomes in the intervention group using data from the process evaluation in intervention health facilities. To ...

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link.springer.com/article/10.1007/s11606-019-05581-8

Integrating Community Health Workers into Safety-Net ...

Evidence shows community health workers (CHWs) can effectively deliver proven behavior-change strategies to prevent type 2 diabetes mellitus (diabetes)

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journals.lww.com

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Task-sharing with community health workers to treat...

Many studies have implemented and evaluated task-sharing interventions with community health workers (CHWs) to manage hypertension.

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researchgate.net

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A Community Health Worker-Led Intervention to Improve ...

We analyzed the outcome of blood pressure (BP) control using pooled data from two community health worker interventions in New York City ...