Improving Medication Adherence in Hypertensive Patients (HTNmobile)

This study has been withdrawn prior to enrollment.
(Collaborator was not clear on how best to proceed with this project.)
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01826435
First received: April 4, 2013
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: Electronic Intervention

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Enrollment: 0
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)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826435

Locations
United States, North Carolina
Duke University Health System Clinic
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01826435     History of Changes
Other Study ID Numbers: Pro00043793
Study First Received: April 4, 2013
Last Updated: January 24, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014