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Improvement of Intentional and Unintentional Non-adherence in the Elderly

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01512238
First Posted: January 19, 2012
Last Update Posted: October 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Aarhus
  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:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Medicine adherence [ Time Frame: One year ]

Secondary Outcome Measures:
  • Number of generic substitution [ Time Frame: One year ]
  • 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 ]
  • Intentional and unintentional non-adherence association with generic substitution and use of non-prescription drugs, herbal medicine and dietary supplements [ Time Frame: One year ]

Enrollment: 630
Study Start Date: February 2010
Study Completion Date: November 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01512238     History of Changes
Other Study ID Numbers: CO01
First Submitted: January 4, 2012
First Posted: January 19, 2012
Last Update Posted: October 1, 2014
Last Verified: December 2013

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