Diabetes, Diabete Type 2
Conditions
Brief summary
The purpose of this study is to determine if a novel smartphone-based medication adherence platform accompanied by directed pharmacist intervention can improve A1c control and medication compliance in non-insulin dependent diabetics.
Detailed description
This study will employ a case-crossover design where patients will undergo both a standard of care arm as well as an intervention arm (See Figure 1). Half of the study participants will be randomized and enrolled in the standard of care arm for the initial 3 months and then transition to the intervention arm for 3 months. The remaining patients will be enrolled in the intervention arm for the initial 3 months and then transitioned to the standard of care arm. Primary outcomes will be the change from pre-intervention baseline in hemoblobin A1c (HgA1c) between the Dayamed Arthur platform and standard of care. Secondary outcomes will include change in MAS, the change in RMA from week 1 of intervention arm to week 12, comparison of historical MPR and PDC with patient's RMA at week 1 of intervention arm, and correlation of change in RMA and MAS score during intervention arm. Furthermore, we will measure sustained change in MAS in the patient population who begin study in the intervention arm and are subsequently transitioned to standard of care. We will also collect information patient usability/acceptability and provider satisfaction with the Dayamed Arthur platform. Exploratory outcomes will include potential reduction in healthcare resource utilization based on avoidance of therapy escalation in patients with improved compliance, as well as psychosocial factors associated with improved adherence Reduction of HgbA1c by 0.5% from pre-intervention baseline for individuals on the DayaMed intervention compared to standard of care
Interventions
BEHAVIORALDayamed Arthur a novel intelligent medication adherence platform
Novel smart phone adherence application configured with subject pharmacy data providing accurate reminders of when to take medications and providing auditable user feed back to clinical care teams for patient response directed provider intervention.
Sponsors
VA Sierra Nevada Health Care System
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study will employ a case-crossover design where patients will undergo both a standard of care arm as well as an intervention arm. Half of the study participants will be randomized and enrolled in the standard of care arm for the initial 3 months and then transition to the intervention arm for 3 months. The remaining patients will be enrolled in the intervention arm for the initial 3 months and then transitioned to the standard of care arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Assigned primary care provider at VA Sierra Nevada Healthcare System (VASNHCS) * Diagnosis of type 2 diabetes * Own a smart phone/tablet * HgbA1c drawn at or within 30 days of study enrollment. * Uncontrolled A1c defined as an A1c \>9 in the following order of preference * Last 3 A1cs \>9% in the last 2 year * Last 2 A1cs \>9% in the last 2 years * Last A1c \>9% in the last 2 years * 2-year average A1c \>9%
Exclusion criteria
* Actively on insulin therapy * Unable to install DayaMed application onto their phone/tablet * Unable to load medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from pre-intervention baseline in hemoblobin A1c | 3 months | The change from pre-intervention baseline in hemoblobin A1c (HgA1c) to 3 months in the intervention arm compared to change from baseline to 3 months in the standard of care arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Medication Adherence Score from baseline | 3 months | change from baseline to 3 months in medication adherence score in the intervention arm compared to change from baseline to 3 months in medication adherence score in the standard of care arm |
Countries
United States
Outcome results
None listed