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WithdrawnNCT01826435HTNmobileUpdated Jan 28, 2014

Improving Medication Adherence in Hypertensive Patients

An interventional study of Electronic Intervention in Hypertension, sponsored by Duke University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-01-28.

Sponsored by Duke University · Not applicable, Interventional, and Health services research

Why this study was withdrawn
Collaborator was not clear on how best to proceed with this project.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

Browse Hypertension studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralElectronic 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.

06

What researchers measure

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.

    Time frame: 3 months

07

Study locations

1 site
  • Duke University Health System Clinic
    Durham, North Carolina 27705, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01826435
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Apr 8, 2013
Start date
Jan 2014
Primary completion
Aug 2014 (estimated)
Completion
May 2015 (estimated)
Last update
Jan 28, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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