VA Sierra Nevada Health Care System
Reno, Nevada, 89502, United States
NCT Number: NCT05789706
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Reno, Nevada, 89502, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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
Time frame: 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
VA Sierra Nevada Health Care System
Fed
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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