NCT01296594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

February 14, 2011

Last Update Submit

April 5, 2019

Conditions

High Blood PressureSubstance Abuse

Outcome Measures

Primary Outcomes (1)

  • self reports of medication adherence

    month 3

Secondary Outcomes (1)

  • ambulatory (24-hour) blood pressure

    month 3

Study Arms (2)

Usual Care

ACTIVE COMPARATOR
Other: Usual Care

usual care with cell phone monitoring and CM

EXPERIMENTAL

In the CM condition, patients will carry a cell phone and record and send in time- and date-stamped self videos of medication ingestion.

Behavioral: Contingency Management

Interventions

Usual CareOTHER

Usual Care

Usual Care
Contingency ManagementBEHAVIORAL

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.

usual care with cell phone monitoring and CM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • uncontrolled psychiatric disorders
  • significant cognitive impairment
  • non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

HypertensionSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesChemically-Induced DisordersMental Disorders

Study Officials

  • Nancy M Petry, Ph.D.

    University of Conncecticut Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2011

First Posted

February 15, 2011

Study Start

February 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

April 9, 2019

Record last verified: 2019-04

Locations

US(1)