Improving Medication Adherence in Hypertensive Patients

NCT01826435 | Withdrawn

• 1 other identifier: Pro00043793
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Proportion of Days Covered (PDC)

  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.

  3 months

Study Arms (1)

Electronic Intervention

EXPERIMENTAL

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

Interventions

Electronic Intervention BEHAVIORAL

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.

Electronic Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System Clinic

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 8, 2013
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: May 1, 2015
• Last Updated: January 28, 2014

Record last verified: 2014-01

Locations

US (1)