N/A
Completed N=319
Improving Health in Diabetes Project
Source: ClinicalTrials.gov NCT02672176 ↗Enrolled (actual)
319
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Diabetes Self-efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)- Scores at Baseline — 3.66; 3.67 Units on a scale — p=0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diabetes Self-efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)- Scores at Baseline |
3.66; 3.67 | 0.05 |
| PRIMARY Diabetes Self-Efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF) |
3.71; 4.05 | 0.05 |
| PRIMARY Diabetes Self-Efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)- Scores at 9-months |
3.95; 3.97 | 0.05 |
| SECONDARY Depression Severity Measured by PHQ-9 |
5.69; 4.81 | 0.05 |
| SECONDARY Perceived Stress Measured by PSS |
5.37; 5.22 | 0.05 |
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Diagnosis of Diabetes Mellitus (type 2)
- Receiving care at one of the UC Davis Primary Care participating clinics (hospital-based Primary Care Clinic, the Folsom Primary Care Clinic)
- Able to read, write, and speak English
- Has access to a telephone and computing device
- Has had experience with use of a mobile smartphone & applications
- HgbA1C over 6.5%
Exclusion Criteria
- Does not have Diabetes Mellitus
- Primary language is not English
- Pregnant women
- Those that not have access to a telephone or computing device
- Has a HgbA1C value under 6.5%
Data sourced from ClinicalTrials.gov (NCT02672176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.