Clinical trial NCT05789706: Use of a Smart-phone Based Medication Adherence Platform to Improve Outcomes in Uncontrolled Non-insulin Dependent Diabetes Among Veterans
Official title: Use of a Smart-phone Based Medication Adherence Platform to Improve Outcomes in Uncontrolled Non-insulin Dependent Diabetes Among Veterans: a Pragmatic, Point-of-care, Implementation Effectiveness Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Diabete Type 2
Lead sponsor: VA Sierra Nevada Health Care System
Sponsor class: FED
First posted: 2023-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change from pre-intervention baseline in hemoblobin A1c
timeFrame: 3 months
Secondary outcomes:
measure: Change in Medication Adherence Score from baseline
timeFrame: 3 months
Other outcomes:
Locations:
city: Reno
country: United States
facility: VA Sierra Nevada Health Care System
state: Nevada
Study officials:
References: