- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01291966
Efficacy of a Intervention to Reduce Medication Errors and Improve Adherence (ATEM-AP)
February 8, 2011 updated by: Hospital Universitario Reina Sofia de Cordoba
Efficacy of a Intervention to Reduce Medication Errors and Therapeutic Failure in Patients Over 65 Years Polypharmacy
The purpose of this study is to demonstrate that an intervention based on the motivational interview directed to patients with polypharmacy to improve the Therapeutic Adherence and to reduce the errors of Medication in major measure that the habitual intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
154
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Córdoba, Spain, 14011
- Unidad Docente de Medicina Familiar y Comunitaria
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with polypharmacy (5 or more medicines)
- That detects to them a problem of Therapeutic Adherence
- That agree to take part in the study
Exclusion Criteria:
- Immobilized patients or with an index of Barthel lower than 60 points
- Incapable to fulfill ABVD
- Patients with cognitive deterioration
- Patients with diagnosis of ictus in the last 6 months
- That has been admitted to hospital 2 or more times in the last year Institutionalized patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motivational interview
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
medication errors in the patients
Time Frame: Baseline, 1, 3 and 6 months
|
Medication errors before and after the intervention in each group
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Baseline, 1, 3 and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of adherence
Time Frame: Baseline and 6 months
|
To measure adherence to treatment will use a combination of direct methods (counting of medication) and indirect tests are passed or self-reported compliance test Haynes-Sackett and Morisky-Green test
|
Baseline and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Moral RR, Torres LA, Ortega LP, Larumbe MC, Villalobos AR, Garcia JA, Rejano JM; Collaborative Group ATEM-AP Study. Effectiveness of motivational interviewing to improve therapeutic adherence in patients over 65 years old with chronic diseases: A cluster randomized clinical trial in primary care. Patient Educ Couns. 2015 Aug;98(8):977-83. doi: 10.1016/j.pec.2015.03.008. Epub 2015 Mar 18.
- Perula de Torres LA, Pulido Ortega L, Perula de Torres C, Gonzalez Lama J, Olaya Caro I, Ruiz Moral R; Grupo corporativo Estudio ATEM-AP. [Efficacy of motivational interviewing for reducing medication errors in chronic patients over 65 years with polypharmacy: Results of a cluster randomized trial]. Med Clin (Barc). 2014 Oct 21;143(8):341-8. doi: 10.1016/j.medcli.2013.07.032. Epub 2013 Dec 28. Spanish.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
January 26, 2011
First Submitted That Met QC Criteria
February 8, 2011
First Posted (Estimate)
February 9, 2011
Study Record Updates
Last Update Posted (Estimate)
February 9, 2011
Last Update Submitted That Met QC Criteria
February 8, 2011
Last Verified
December 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- PI-0101/2008
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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