Use of a Smart-phone Based Medication Adherence Platform to Improve Outcomes in Uncontrolled Non-insulin Dependent Diabetes Among Veterans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-24

Study Completion Date

2023-03-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Diabetes Diabete Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Arm

Patients will have Dayamed Arthur a novel intelligent medication adherence platform installed on their smartphone and configured with their pharmacy data providing accurate prompts and reminders to patients to take medications as directed In addition to the prompts patient all auditable information will be relayed to their PACT CPS through a provider dashboard allowing for timely and directed clinical intervention. Dayamed Arthur will provide automated alerts to the patients care team in specific scenarios.

Group Type EXPERIMENTAL

Dayamed Arthur a novel intelligent medication adherence platform

Intervention Type BEHAVIORAL

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.

Standard of Care Arm

Study subjects will be counseled on medication adherence and strategies to remember how to take their medications correctly. Study subjects will then be followed as clinically indicated by their clinical care team.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dayamed 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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%