CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 319 enrolled
Drug / intervention
Usual Care +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02672176
NCT02672176N/ACompleted

Patient and Provider Engagement and Empowerment Through Technology (P2E2T2) Program to Improve Health in Diabetes

University of California, Davis·interventional·Posted Feb 3, 2016·Updated Oct 23, 2019

In Brief

A clinical study evaluating Usual Care and P2E2T2 Program for Diabetes Mellitus. Completed, enrolled 319 participants across 1 site.

Detailed Summary

The overall goal of this proposal is to enhance the supports and resources available to patients with diabetes to assist them to achieve their health goals. The investigators will evaluate an innovative program that uses nurse health coaching, motivational interviewing techniques, wireless sensors and mobile health (mHealth) technology. In this program, patients will receive timely, tailored nurse coaching feedback to facilitate behavior change using mHealth technology, thus bridging bidirectional exchange of meaningful information among patient, nurse coach and provider. The investigators will conduct a randomized controlled trial among patients receiving chronic disease management at the University of California Davis(UC Davis) Primary Care Network. The patients who are eligible for inclusion in the study will be randomized to one of two arms of the trial: 1) Usual care (Care Coordination) administered by UC Davis Health Management and Education; or 2) the Patient and Provider Engagement and Empowerment through Technology (P2E2T2) Program to Improve Health in Diabetes. The hypothesis is that patients in the P2E2T2 arm of the study will be more engaged in identifying and achieving health goals related to their diabetes and will achieve better health outcomes compared to patients receiving usual care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 3, 2016
Enrollment StartFeb 1, 2016
Primary CompletionDec 31, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.4 years ago

Interventions

Usual Carebehavioral

This program is a well-established program within the UC Davis Health System, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals and appointments for the patient, facilitate communication among members of the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis.

P2E2T2 Programbehavioral

The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows: