Technology-Enabled Nursing for Type 2 Diabetes and High Blood Pressure
(EXTEND Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMatthew Crowley, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Duke University

No Placebo Group

Trial Summary

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.

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.

See 5 more

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.

See 4 more

Treatment Details

Interventions

EXTEND (Behavioral Intervention)
EXTEND-Monitoring (Behavioral Intervention)
EXTEND-Nursing (Behavioral Intervention)
EXTEND Plus (Behavioral Intervention)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Active Control

Group I: EXTEND PlusExperimental Treatment1 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: EXTENDActive Control1 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).