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Home > "A" Clinical Trials Conditions > Adherence in Clinical Trials-Induction Strategies  Adherence in Clinical Trials-Induction Strategies
Adherence in Clinical Trials-Induction Strategies
For Condition: Cardiovascular Diseases
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) , National Institute of Nursing Research (NINR)
Synopsis: 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.
Details: 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:
Study Type: Observational, Retrospective Study
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: 4441;
Study Start Date: September 1992
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005453
Other Cardiovascular Diseases Studies:
1. Psychophysiology of Cardiovascular Reactivity
2. Myocardial Infarction Triage and Intervention Project (MITI)
3. Genomewide Search for Loci Underlying Metabolic Syndrome
4. Lay-Led Smoking Cessation Approach for Southeast Asian Men
5. Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training
Related Studies:
Other Cardiovascular Diseases Clinical Trials
Other Clinical Trials
Other Clinical Trials
Adherence in Clinical Trials-Induction Strategies
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