Clinical trial NCT01512238: Improvement of Intentional and Unintentional Non-adherence in the Elderly
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medication Adherence
Keywords: 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
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 630
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
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

Brief summary: 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.

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 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:

Primary outcomes:
measure: Medicine adherence
timeFrame: One year
Secondary outcomes:
measure: Number of generic substitution
timeFrame: One year
measure: 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'
timeFrame: Actually day
measure: Intentional and unintentional non-adherence association with generic substitution and use of non-prescription drugs, herbal medicine and dietary supplements
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: Aarhus University Hospital
name: Else Marie S Damsgaard, Professor
role: STUDY_CHAIR
affiliation: Horsens Hospital
name: Ishay Barat, Ph.D.
role: STUDY_CHAIR
References: