Adherence in Clinical Trials-Induction Strategies

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005453
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: September 2002
  Purpose

To examine the effects of two strategies of inducing enhanced adherence to medication in the context of a clinical trial: habit training versus habit training plus problem solving.


Condition
Cardiovascular Diseases

Study Type: Observational
Study Design: Time Perspective: Retrospective

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1992
Estimated Study Completion Date: June 1997
Detailed Description:

BACKGROUND:

The success of any therapeutic intervention, whether preventive or curative, is ultimately dependent on the individual's adherence to treatment. Unfortunately, the failure of a large percentage of patients to adhere to prescribed medical regimens is a widely recognized and well documented phenomenon. It has been estimated that as many as 50 percent of patients do not take their prescribed medications, and of those remaining, less than two-thirds take their medication as prescribed.

The interventions, implemented at the outset of pharmacologic intervention within the clinical trial, were timed to yield maximum effectiveness. Such randomized induction studies had not yet been undertaken. By capitalizing on a new unobtrusive assessment technique that generated the time of medication intake over prolonged periods, the study produced a unique set of data suitable for the study of recurring cycles in medication intake patterns.

The study was part of a two grant initiative entitled "Evaluation of Adherence Interventions in Clinical Trials". The initiative was developed by the Behavioral Medicine Branch staff and Clinical Trials Branch staff as well as members of the Clinical Applications and Prevention Advisory Committee Behavioral Medicine and Prevention Working Groups. The initiative was released in September, 1991 and awarded in September, 1992.

DESIGN NARRATIVE:

Randomized, double-blind, two-group design. Within each of the groups, half of the subjects were on lovastatin and half on placebo. The main outcome measure was medication intake monitored daily and unobtrusively with the MEMS electronic monitor. For each subject, event time series of six months duration were obtained. The effect of these interventions were determined on average adherence at two and six months; and variability of adherence. In addition, the relative cost effectiveness of each intervention was examined by a recalculation of sample size needs based upon increased adherence and related cholesterol lowering. Ancillary goals of the study included: determining the components of variability of medication intake using statistical modeling techniques; and covariates of treatment effects, including baseline daily hassles, problem solving skills, and generalized expectancy for success.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005453     History of Changes
Other Study ID Numbers: 4441
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014