Improving Medication Adherence in Hypertensive Patients

Not Applicable

Withdrawn

• Conditions: Hypertension
• Interventions: Behavioral: Electronic Intervention

• Registration Number: NCT01826435
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-08
• Status Verified: 2014-01
• Study Start: 2014-01
• Last Update Submitted: 2014-01-24
• Last Update Posted: 2014-01-28
• Primary Completion: 2014-08
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Enrolled in the primary care clinic for the past 6 months
• New or existing prescription for hypertension
• Poorly controlled mean systolic blood pressure (SBP) in the last 12 months (>140/90 Hg)

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Exclusion Criteria

• Hospitalized for a stroke, myocardial infarction, coronary artery revascularization in the past 3 months,
• Diagnosis of metastatic cancer;
• Active diagnosis of psychosis or dementia documented in medical record;
• Does not have access to the appropriate technology required
• Is not willing to use said device to receive notifications for the study;
• Does not live independently (assisted living or nursing home residents) or otherwise institutionalized or receiving home health care
• Severely impaired hearing, vision or speech (unless technological aides allow them full functionality)
• Planning to leave the area or change primary care clinics prior to the anticipated end of participation;
• Unable to read and understand spoken English
• Participation in another cardiovascular disease (CVD) study
• Another household member enrolled in study;
• Arm size > 50cm

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electronic Intervention	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Days Covered (PDC)	3 months	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.

Trial Locations

Locations (1)

Duke University Health System Clinic; 🇺🇸 Durham, North Carolina, United States