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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
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Blood Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 14, 2011
Last Updated
April 5, 2019
Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
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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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