Improving Antihypertensive Medication Adherence
Primary Purpose
High Blood Pressure, Substance Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care
Contingency Management
Sponsored by
About this trial
This is an interventional treatment trial for High Blood Pressure
Eligibility Criteria
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
Sites / Locations
- University of Connecticut Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual Care
usual care with cell phone monitoring and CM
Arm Description
In the CM condition, patients will carry a cell phone and record and send in time- and date-stamped self videos of medication ingestion.
Outcomes
Primary Outcome Measures
self reports of medication adherence
Secondary Outcome Measures
ambulatory (24-hour) blood pressure
Full Information
NCT ID
NCT01296594
First Posted
February 14, 2011
Last Updated
April 5, 2019
Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01296594
Brief Title
Improving Antihypertensive Medication Adherence
Official Title
Improving Antihypertensive Medication Adherence
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Blood Pressure, Substance Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Title
usual care with cell phone monitoring and CM
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
self reports of medication adherence
Time Frame
month 3
Secondary Outcome Measure Information:
Title
ambulatory (24-hour) blood pressure
Time Frame
month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy M Petry, Ph.D.
Organizational Affiliation
University of Conncecticut Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
12. IPD Sharing Statement
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Improving Antihypertensive Medication Adherence
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