- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01512238
Improvement of Intentional and Unintentional Non-adherence in the Elderly
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to describe in the elderly:
- Association between medicine adherence and number of generic substitution
- 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'
- 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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control
|
|
Pharmaceutical care
|
Information about medicine, sideeffect, adherence
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Medicine adherence
Time Frame: One year
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of generic substitution
Time Frame: One year
|
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
|
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
|
One year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Else Marie S Damsgaard, Professor, Aarhus University Hospital
- Study Chair: Ishay Barat, Ph.D., Horsens Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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