Medication AdherenceATEM-APNCT01291966
Efficacy of a Intervention to Reduce Medication Errors and Improve Adherence
A study testing Motivational interview in people with Medication Adherence and Patient Compliance, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence, Patient Compliance
- What is being tested?
- Motivational interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to Sep 2010
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients with polypharmacy (5 or more medicines)
- That detects to them a problem of Therapeutic Adherence
- That agree to take part in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Unidad Docente de Medicina Familiar y Comunitaria
Córdoba, Córdoba, 14011
About this study
Official title: 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.
- Conditions
- Medication Adherence, Patient Compliance
- Being tested
- Motivational interview
- Keywords
- medication errors, Patient Compliance, patient safety, polypharmacy
- Medical subject headings
- Medication Adherence, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewBehavioural
Also called Counseling, Patient-centered method
| Study group | Role | What they receive |
|---|---|---|
| Motivational interview | Experimental | Not described Receives: Behavioral: Motivational interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
medication errors in the patients
Medication errors before and after the intervention in each group
Measured: Baseline, 1, 3 and 6 months
Secondary outcomes (1)
Percentage of adherence
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
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startJan 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Reina Sofia de Cordoba
- Sponsor type
- Other government
- Collaborators
- Sociedad Andaluza de Medicina Familiar y Comunitaria, Sociedad Española de Medicina Familiar y Comunitaria
- Investigators
- Luis A Perula, PH D, Principal investigator, Andalusian Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291966
- Sponsor's protocol ID
- PI-0101/2008
- Acronym
- ATEM-AP
- Status last verified
- Dec 2010
- First submitted
- 26 Jan 2011
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25858633Perula 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.
PubMed 24378144
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Intervention to Reduce Medication Errors and Therapeutic Failure in Patients Over 65 Years Polypharmacy
- ClinicalTrials.gov ID
- NCT01291966
- Acronym / sponsor ID
- ATEM-AP / PI-0101/2008
- Conditions
- Medication Adherence, Patient Compliance
- Keywords
- medication errors, Patient Compliance, patient safety, polypharmacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Hospital Universitario Reina Sofia de CordobaOther government
- Collaborators
- Sociedad Andaluza de Medicina Familiar y Comunitaria, Sociedad Española de Medicina Familiar y Comunitaria
- Study start
- Jan 2010
- Study completion
- Sep 2010 (actual)
- First posted
- 9 Feb 2011 (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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motivational interview | Experimental | Behavioral: Motivational interview |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients with polypharmacy (5 or more medicines)
- That detects to them a problem of Therapeutic Adherence
- That agree to take part in the study
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Motivational interviewAlso: Counseling, Patient-centered method | Behavioural | Motivational interview |
Primary outcome
medication errors in the patients
Time frame: Baseline, 1, 3 and 6 months
Medication errors before and after the intervention in each group
1 secondary outcome
Percentage of adherence
Time frame: Baseline and 6 months
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 9 Feb 2011.
- Derived from this study: PubMed 25858633Moral 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.
- Derived from this study: PubMed 24378144Perula 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.
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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.
Luis A Perula, PH D principal investigator
Andalusian Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interview in people with Medication Adherence and Patient Compliance, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
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 3 inclusion and 5 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 9 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
medication errors in the patients (time frame: Baseline, 1, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01291966, which also lists 2 linked publications.
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 9 Feb 2011.