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Improvement of Intentional and Unintentional Non-adherence in the Elderly

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01512238
First received: January 4, 2012
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose is to study if different factors influence medicine adherence in elderly people. In this study number of generic substitution and use of non-prescription drugs, herbal medicine and dietary supplement is in focus.


Condition Intervention
Medication Adherence
 Other: Pharmaceutical care

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Improvement of Intentional and Unintentional Non-adherence in the Elderly. Importance of Pharmaceutical Care, Generic Substitution, Non-prescription Drugs, Herbal Medicine and Dietary Supplements

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Medicine adherence [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of generic substitution [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Use of non-prescription drugs, herbal medicine and dietary supplements and frequency of interaction between 'prescription drugs' and 'non-prescription drugs, herbal medicine and dietary supplements' [ Time Frame: Actually day ] [ Designated as safety issue: No ]
  • Intentional and unintentional non-adherence association with generic substitution and use of non-prescription drugs, herbal medicine and dietary supplements [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 630
Study Start Date: February 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pharmaceutical care Other: Pharmaceutical care
Information about medicine, sideeffect, adherence
Other Name: Pharmaceutical Services
Control

Detailed Description:

The purpose of this study is to describe in the elderly:

  1. Association between medicine adherence and number of generic substitution
  2. Association between medicine adherence and use of non-prescription drugs, herbal medicine and dietary supplements and interaction between 'prescription drugs' and 'non-prescription drugs, herbal medicine and dietary supplements'
  3. Intentional and unintentional non-adherence

Some of the data in the present study were originally collected as part of a major research project 'Methods for Improving Compliance with Medicine Intake' (MICMI). The study sample of 945 persons was randomly selected into three groups: two intervention groups and one control group. Interventions were pharmaceutical care and an electronic reminder system. All groups were followed for one year.

Data in the present study is from the pharmaceutical care group and the control group, and is descriptive.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Persons aged 65 years or older, living in their own homes without assistance to medicine administration in the Municipality of Aarhus, Denmark and who were in long-term treatment with > 4 prescription drugs at the beginning of the project

Criteria

Inclusion Criteria:

  • Aged 65 years or older
  • Living in their own homes
  • Without assistance to medicine administration
  • Living in the Municipality of Aarhus, Denmark
  • Long-term treatment with > 4 prescription drugs

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512238

Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: Else Marie S Damsgaard, Professor Aarhus University Hospital
Study Chair: Ishay Barat, Ph.D. Horsens Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01512238     History of Changes
Other Study ID Numbers: CO01
Study First Received: January 4, 2012
Last Updated: January 11, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Medicine adherence
Drug substitution
Herb-drug interaction
Herbal medicine
Dietary supplements
 Over-the-counter products
On-line prescription records
Personal electronic medicine profile
Intentional non-adherence
Unintentional non-adherence

ClinicalTrials.gov processed this record on May 23, 2013