Phase 4
N=1,400
ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus
Diabetes Mellitus Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02910089 ↗Enrolled (actual)
1,400
Serious AEs
0.4%
Results posted
Aug 2019
Primary outcome: Primary: Glycosylated Hemoglobin (HbA1c): — -0.75; -0.79 Percentage of HbA1c
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Shared Decision Making (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycosylated Hemoglobin (HbA1c): |
-0.75; -0.79 | — |
| SECONDARY Medication Adherence (PDC Measure) |
67.5; 66.2 | — |
| SECONDARY Percentage (Proportion x 100) of Patients Achieving Optimal Adherence |
46.2; 45.0 | — |
| SECONDARY Patients Achieving HbA1c |
34.8; 38.0 | — |
Summary
The purpose of this study is to evaluate whether a combination of pharmacist-delivered patient engagement techniques improves disease control and medication adherence among patients with poorly-controlled diabetes compared with usual care. These engagement techniques include shared decision-making and brief negotiated interviewing and are delivered telephonically.
Eligibility Criteria
Inclusion:
- Commercially-insured beneficiaries
- Receive all medical/prescription drug benefits through Horizon
- On ≥1 one oral hypoglycemic agent
- Latest HbA1c measurement ≥ 8% (within previous 6 months)
- Provided phone number to Horizon
Exclusion:
- Currently using any insulin
Data sourced from ClinicalTrials.gov (NCT02910089). 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.