Improving Antihypertensive Medication Adherence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01296594
First received: February 14, 2011
Last updated: July 23, 2013
Last verified: July 2013

February 14, 2011
July 23, 2013
February 2011
July 2012   (final data collection date for primary outcome measure)
self reports of medication adherence [ Time Frame: month 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01296594 on ClinicalTrials.gov Archive Site
ambulatory (24-hour) blood pressure [ Time Frame: month 3 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Improving Antihypertensive Medication Adherence
Improving Antihypertensive Medication Adherence

Poor adherence to antihypertensive medications is associated with morbidity, and data suggest that substance abuse may contribute to poor adherence. Contingency management (CM), an intervention highly efficacious for improving outcomes of substance abusers, shows promise in improving medication adherence in a handful of small trials. CM involves providing tangible reinforcement each time the behavior (medication ingestion) is exhibited. Thus far, studies evaluating CM for increasing medication adherence have utilized MEMS caps, but reinforcement of adherence via MEMS caps is done relatively infrequently and with delay, hindering its efficacy. A widely utilized technology that may be more appropriate for reinforcing medication adherence is cell phones, which can record the process of pill ingestion through video functions. As regular monitoring and feedback is important in the efficacy of CM, patients can be provided with daily messages regarding adherence and CM earnings. In this pilot study, we propose to randomize 40 hypertensive substance abusing patients with suboptimal adherence to antihypertensive medications to one of two 12-week treatment conditions: (1) usual care, or (2) usual care with cell phone monitoring and CM. In the CM condition, patients will carry a cell phone and record and send in time- and date-stamped self videos of medication ingestion. These patients will receive congratulatory messages or reminders about adherence, and they will earn vouchers each time medication ingestion occurs at the appropriate time, along with bonuses for sustained adherence. We hypothesize that the CM condition will improve self report and pill count measurements of medication adherence and that it will result in decreased blood pressure. Results from this study may have widespread implications for the use of cell phones as a novel technology to improve medication adherence.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • High Blood Pressure
  • Substance Abuse
  • Other: Usual Care
    Usual Care
  • Behavioral: Contingency Management
    This intervention consists of congratulatory messages or reminders about adherence, and participants will earn vouchers each time medication ingestion occurs at the appropriate time, along with bonuses for sustained adherence.
  • Active Comparator: Usual Care
    Intervention: Other: Usual Care
  • Experimental: usual care with cell phone monitoring and CM
    In the CM condition, patients will carry a cell phone and record and send in time- and date-stamped self videos of medication ingestion.
    Intervention: Behavioral: Contingency Management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age >18 years
  • have been prescribed one or more antihypertensive medications
  • blood pressure of >120 mmHg systolic or >80 mmHg diastolic
  • substance use problem
  • willing to use a cell phone to record medication ingestion for three months
  • have a valid photo ID (driver's license, passport, state ID) and are willing to sign an off-campus property transfer form and return study equipment at the end of study participation

Exclusion Criteria:

  • uncontrolled psychiatric disorders
  • significant cognitive impairment
  • non-English speaking
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01296594
11-080-3, P30DA023918
Yes
University of Connecticut Health Center
University of Connecticut Health Center
National Institute on Drug Abuse (NIDA)
Principal Investigator: Nancy M Petry, Ph.D. University of Conncecticut Health Center
University of Connecticut Health Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP