Improving Medication Adherence in Hypertensive Patients (HTNmobile)
The study team is proposing a single arm intervention to test the effect of an electronic intervention on medication use among individuals with a prescription for hypertension/high blood pressure. The investigator proposes that technology like text messaging, email, web applications and mobile apps with proven, nurse intervention scripts, will lead to significant, cost-effective improvements in hypertension medication use.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Improving Medication Adherence in Hypertensive Patients|
- Proportion of Days Covered (PDC) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Proportion of Days Covered (PDC), a Pharmacy Quality Alliance (PQA)-recommended metric for estimation of medication adherence for patients using chronic medications, will be used to identify the percentage of patients taking medications in a particular drug class with high adherence (PDC > 80% for the individual). Participants with a PDC ≤0.8 will be categorized as having "poor" adherence, and those with a PDC >0.8 will be categorized as having "good" adherence. For analyses, the PDC will be dichotomized at 0.8 (PDC >0.8) over the entire 3 month follow-up, yielding a single assessment of pill refill adherence that will be used as the primary outcome.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Electronic Intervention
Over the three months, participants will receive a technology intervention. This will include text or email encounter notifications associated with appropriate mobile or online self-management information for medication adherence and behavior change.
Behavioral: Electronic Intervention
Patients will be able to receive the intervention notifications over the electronic/multimedia mode they prefer; selecting either text messaging/mobile web and/or email/online web. Text message or email alerts with an included uniform resource locator (URL) link to the specified mobile or online web site will be utilized to notify patients of a pending encounter available on mobile. Topics that will be addressed in the intervention include medication and side effects, social support, hypertension knowledge, memory and smoking. All intervention encounters that are designed to collect responses from the patient will require the patient to supply credentials before responding to the encounter; thus, ensuring privacy of the patient session, as well as patient-specific tracking of responses.
The intervention will incorporate a scalable electronic intervention using Email/Web Apps and Short Message Service (SMS)/Mobile Web Apps. The study team will examine the participants' responses to the electronic encounters in the technology-only intervention throughout the 3-month study timeframe.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01826435
|United States, North Carolina|
|Duke University Health System Clinic|
|Durham, North Carolina, United States, 27705|