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Behavioral Intervention

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

N/A

Waitlist Available

Led By Ryan J Shaw, RN, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of type 2 diabetes by International Classification of Diseases (ICD) code or treatment with glucose-lowering medication or mention in clinical notes

Diagnosis of hypertension by ICD code or treatment with blood pressure-lowering medication or mention in clinical notes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3, 6, 9, 12, 18 and 24 months

Awards & highlights

EXTEND Trial Summary

This trial will study if mobile devices and nursing support can help people with diabetes and hypertension better manage their conditions.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves technology use and nurse support rather than medication, traditional side effects are not applicable. However, participants may experience issues related to technology use such as privacy concerns or stress from constant health monitoring.

EXTEND Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with type 2 diabetes.

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

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

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My diabetes control is poor, with my HbA1c always above 8.0% in the last 6 months.

EXTEND Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6, 9, 12, 18 and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6, 9, 12, 18 and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, 9, 12, 18 and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in HbA1c

Secondary outcome measures

Change in Diabetes Self-Management Questionnaire

Change in Perceived Competence Scale

Change in blood pressure

+5 more

EXTEND Trial Design

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).

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,358 Previous Clinical Trials

3,419,849 Total Patients Enrolled

National Institute of Nursing Research (NINR)NIH

579 Previous Clinical Trials

10,376,162 Total Patients Enrolled

Ryan J Shaw, RN, PhDPrincipal InvestigatorDuke University School of Nursing

Media Library

EXTEND (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05120544 — N/A

Type 2 Diabetes Research Study Groups: EXTEND Plus, EXTEND

Type 2 Diabetes Clinical Trial 2023: EXTEND Highlights & Side Effects. Trial Name: NCT05120544 — N/A

EXTEND (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05120544 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this experiment ongoing?

"As per clinicaltrials.gov, this research study is still searching for suitable individuals to participate in the trial. The original posting date was February 17th 2022 and it was last updated on July 27th 2022."

Answered by AI

Is there an age limit for eligibility in this clinical experiment?

"The qualifications for enrolment in this medical trial stipulate that patients must be at least 30 years of age and no older than 75."

Answered by AI

Is there eligibility criteria for participants to join this clinical investigation?

"This medical study is inviting 220 individuals aged 30-75 who have type 2 diabetes mellitus to participate. The primary requisites for enrolment are: a verified diagnosis of type two diabetes, HbA1c levels over 8% for at least one year, hypertension coded in the ICD or being treated with BP medication and poor control thereof as indicated by clinic readings assessing systolic blood pressure beyond 140 mmHg and diastolic above 90mmHg. Additionally, all participants must own an Apple iPhone or Android smartphone, be able to read/speak English fluently and provide informed consent."

Answered by AI

What is the upper limit of participation in this clinical study?

"Affirmative. Research hosted on clinicaltrials.gov demonstrates that this scientific experiment, which was first published on February 17th 2022, is currently recruiting patients. A total of 220 individuals are needed at a single medical centre to participate in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Expanding Technology-Enabled Nurse Delivered Chronic Disease Care

2022. "Expanding Technology-Enabled Nurse Delivered Chronic Disease Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05120544.

All > Diabetes Type 2 > Hypertension