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

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

What data supports the effectiveness of the treatment CHW Session 1 Only, Integrated CHW Intervention for Type 2 Diabetes and High Blood Pressure?

Research shows that telehealth systems, which allow patients to monitor their health at home and receive remote support, can improve blood sugar and blood pressure control in people with type 2 diabetes and high blood pressure. This suggests that similar telehealth coaching treatments could be effective. ^{1 2 3 4 5}

Is telehealth coaching for type 2 diabetes and high blood pressure safe for humans?

Telehealth interventions, including those involving nonclinician health coaches, have been studied for managing conditions like diabetes and high blood pressure. These studies generally focus on improving medication adherence and clinical outcomes, suggesting that such interventions are safe for human use. ^{5 6 7 8 9}

How is the Integrated CHW Intervention treatment for type 2 diabetes and high blood pressure different from other treatments?

The Integrated CHW Intervention is unique because it combines telehealth coaching with community health worker support, allowing patients to monitor their health at home and receive personalized guidance remotely, which is different from traditional in-person care. ^{1 3 5 10 11}

What is the purpose of this trial?

The purpose of this study is to test the effectiveness and implementation process of a culturally and contextually tailored telehealth-based community health workers (CHW) led coaching intervention for hypertension control among South Asian patients with co-morbid Diabetes Mellitus type II (DMII) and hypertension. The primary aims are to test the effectiveness of a CHW-led telehealth intervention compared to usual care, and using Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR), examine the reach, adoption, fidelity, and maintenance of the intervention within clinical and community settings.

Research Team

Nadia Islam, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Identified as of South Asian ethnicity

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

A Randomized Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Patients with Type 2 Diabetes. [2022]

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

Hypertension telemanagement in blacks. [2022]

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

Shared care combined with telecare improves glycemic control of diabetic patients in a rural underserved community. [2022]

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

Web-based care management in patients with poorly controlled diabetes. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Effect of nurse-directed hypertension treatment among First Nations people with existing hypertension and diabetes mellitus: the Diabetes Risk Evaluation and Microalbuminuria (DREAM 3) randomized controlled trial. [2022]

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

Impact of Telehealth Interventions on Medication Adherence for Patients With Type 2 Diabetes, Hypertension, and/or Dyslipidemia: A Systematic Review. [2021]

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

Adherence and persistence with taking medication to control high blood pressure. [2011]

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

Delegating responsibility from clinicians to nonprofessional personnel: the example of hypertension control. [2012]

9. England 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. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of pharmacist-led telemedicine medication management for hypertension established patients during COVID-19 pandemic: A pilot study. [2023]

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

A multifactorial intervention to improve blood pressure control in co-existing diabetes and kidney disease: a feasibility randomized controlled trial. [2022]