Technology-Enabled Nursing for Type 2 Diabetes and High Blood Pressure

(EXTEND Trial)

Overseen By Gina N Pennington, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Glucose-lowering, Blood pressure-lowering

Disqualifiers: Dementia, Psychosis, Life-limiting illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

220 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves monitoring diabetes and hypertension, it's likely you will continue your current treatment.

What data supports the effectiveness of the treatment EXTEND, EXTEND-Monitoring, EXTEND-Nursing, EXTEND Plus for type 2 diabetes and high blood pressure?

Research shows that nurse-led and technology-assisted programs can help people with type 2 diabetes manage their condition better, improve their quality of life, and reduce complications. These programs often involve nurses using technology to guide patients in managing their health, which has been effective in improving blood sugar control and overall health outcomes. ^{1 2 3 4 5}

Is the Technology-Enabled Nursing program safe for humans?

The studies reviewed focus on nurse-led smartphone and mobile health programs for diabetes management, which generally involve safe practices like self-management education and monitoring. These programs have been used in real-world settings without reported safety concerns, suggesting they are generally safe for human use. ^{1 6 7 8 9}

What makes the EXTEND treatment for Type 2 Diabetes and High Blood Pressure unique?

The EXTEND treatment is unique because it integrates technology with nursing care to enhance patient self-management and monitoring, similar to the HeartCareII model for cardiac patients. This approach uses web-based resources and telemonitoring to support patients in managing their conditions, which is different from traditional treatments that may not involve such technology-driven support. ^{10 11 12 13 14}

What is the purpose of this trial?

This trial investigates if using mobile devices to monitor health and getting support from nurses can help people with poorly controlled diabetes and high blood pressure who haven't improved with regular treatments.

Research Team

Matthew Crowley, MD

Principal Investigator

Duke University

Ryan J Shaw, RN, PhD

Principal Investigator

Duke University School of Nursing

Eligibility Criteria

This trial is for adults with uncontrolled high blood pressure and type 2 diabetes, who have had poor management of these conditions over the past year. Participants must be able to give informed consent, speak English, use a smartphone, and have been seen at the primary clinic site in the last year. Pregnant individuals or those living in nursing homes are not eligible.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.

I have been diagnosed with high blood pressure or am on medication for it.

My blood pressure has been above 140/90 in the past year.

Exclusion Criteria

Unable or unwilling to use necessary technology to participate in study

I had a heart attack or similar heart issue in the last year.

You live in a nursing home.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mobile monitoring devices and nursing support for chronic disease self-management

12 months

Initial encounters every two weeks, extended to every four weeks upon achieving treatment goals

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• EXTEND
• EXTEND-Monitoring
• EXTEND-Nursing
• EXTEND Plus

Trial Overview The study is testing two programs: EXTEND and EXTEND Plus. Both involve using mobile devices for monitoring health and receiving nurse support to see if they help patients better manage their diabetes and hypertension on their own.

Participant Groups

Group I: EXTEND Plus Experimental Treatment 1 Intervention

EXTEND Plus participants receive 4 mobile monitoring devices to facilitate chronic disease self-management (glucometer, BP cuff, scale, accelerometer). Device data are transferred to Duke University Health System (DUHS) for use as part of nurse-delivered intervention combining mobile monitoring, self-management support, and medication management. The intervention is administered by clinical registered nurses (RNs) from Duke Primary Care (DPC) or Duke Endocrinology. For the medication management component, RNs work with a study PharmD affiliated with the participant's clinic. The PharmD determines if medication changes are needed, and prescribes accordingly. The RNs deliver EXTEND Plus via scheduled telephone encounters throughout the 12-month intervention. The initial encounter frequency is every two weeks, but may be extended to every four weeks for patients achieving treatment goals.

Group II: EXTEND Active Control 1 Intervention

EXTEND participants receive 4 mobile monitoring devices to facilitate chronic disease self-management (glucometer, BP cuff, scale, accelerometer). Device data are transferred to Duke University Health System (DUHS). Participants can review data and trends within the device apps and modify self-management practices accordingly. The EXTEND group continues chronic disease care with their existing providers during the study, and are instructed at baseline to address management questions via their primary clinics' established avenues (as would be the case for any patient using mobile monitoring in clinical practice).

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

Nurse-led telephone counseling significantly improved health behaviors and self-care for hypertension in low-income older adults, with a medium effect size (Cohen's d = 1.16) after 8 weeks.

The intervention also led to a reduction in systolic blood pressure (Cohen's d = -0.61), suggesting that personalized support can enhance health outcomes in disadvantaged populations using telemonitoring systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone Support and Telemonitoring for Low-Income Older Adults. Jeong, S., Choi, H., Gwon, SH., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a nurse-led smartphone-based self-management programme for people with poorly controlled type 2 diabetes: A randomized controlled trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A participatory action research study to inform combined type 2 diabetes and chronic kidney disease care provided in the context of advanced practice nursing. [2022]

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

Randomized Controlled Trial of Technology-Assisted Case Management in Low Income Adults with Type 2 Diabetes. [2022]

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

Evaluation of a nurse-care management system to improve outcomes in patients with complicated diabetes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Design and implementation of an Omaha System-based integrated nursing management model for patients with newly-diagnosed diabetes. [2019]

6. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a nurse short-message service by cellular phone for people with diabetes. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Theory-based diabetes self-management education with pre-selection of participants: a randomized controlled trial with 2.5 years' follow-up (ELDES Study). [2021]

8. England pubmed.ncbi.nlm.nih.gov

The development and testing of a nurse-led smartphone-based self-management programme for diabetes patients with poor glycaemic control. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Uptake and use of a diabetes management program with a mobile glucometer. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

HeartCareII: home care support for patients with chronic cardiac disease. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Creating technology-enhanced practice: A university-home care-corporate alliance. [2016]

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

Telephone Support and Telemonitoring for Low-Income Older Adults. [2018]

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

The Growing Role of Technology in the Care of Older Adults With Diabetes. [2023]

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

Facilitators and barriers to blood pressure telemonitoring: A mixed-methods study. [2023]