Medication AdherenceNCT01512238
Improvement of Intentional and Unintentional Non-adherence in the Elderly
An observational study of Medication Adherence, run by University of Aarhus.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Pharmaceutical care
- How many people
- 630 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- 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
Who cannot join
None listed.
About this study
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
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.
Read the 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.
- Conditions
- Medication Adherence
- Being tested
- Pharmaceutical care
- 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
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical careOther
Also called Pharmaceutical Services
Information about medicine, sideeffect, adherence
| Study group | Role | What they receive |
|---|---|---|
| Pharmaceutical care | Not described Receives: Other: Pharmaceutical care | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medicine adherence
Measured: One year
Secondary outcomes (3)
Number of generic substitution
Measured: 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'
Measured: Actually day
Intentional and unintentional non-adherence association with generic substitution and use of non-prescription drugs, herbal medicine and dietary supplements
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startFeb 2010
- Primary completionJan 2011
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Else Marie S Damsgaard, Professor, Study chair, Aarhus University HospitalIshay Barat, Ph.D., Study chair, Horsens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512238
- Sponsor's protocol ID
- CO01
- Status last verified
- Dec 2013
- First submitted
- 4 Jan 2012
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01512238
- Acronym / sponsor ID
- CO01
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmaceutical care | – | Other: Pharmaceutical care |
| Control | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaceutical careAlso: Pharmaceutical ServicesInformation about medicine, sideeffect, adherence | Other | Pharmaceutical care |
Primary outcome
Medicine adherence
Time frame: One year
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Else Marie S Damsgaard, Professor study chair
Aarhus University Hospital
Ishay Barat, Ph.D. study chair
Horsens Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Adherence, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medicine adherence (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.