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NCT01296594 Clinical Trial

Improving Antihypertensive Medication Adherence

Substance Abuse Clinical Trial

Official title:
Improving Antihypertensive Medication Adherence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01296594
Other study ID # 11-080-3
Secondary ID P30DA023918
Status Completed
Phase N/A
First received
Last updated
Start date February 2011
Est. completion date July 2012

Study information
Verified date April 2019
Source UConn Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States University of Connecticut Health Center Farmington Connecticut

Sponsors (2)
Lead Sponsor Collaborator
UConn Health National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary self reports of medication adherence month 3
Secondary ambulatory (24-hour) blood pressure month 3
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