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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01291966
Other study ID # PI-0101/2008
Secondary ID
Status Completed
Phase N/A
First received January 26, 2011
Last updated February 8, 2011
Start date January 2010
Est. completion date September 2010

Study information

Verified date December 2010
Source Hospital Universitario Reina Sofia
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 154
Est. completion date September 2010
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational interview


Locations

Country Name City State
Spain Unidad Docente de Medicina Familiar y Comunitaria Córdoba

Sponsors (3)

Lead Sponsor Collaborator
Hospital Universitario Reina Sofia Sociedad Andaluza de Medicina Familiar y Comunitaria, Sociedad Española de Medicina Familiar y Comunitaria

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary medication errors in the patients Medication errors before and after the intervention in each group Baseline, 1, 3 and 6 months Yes
Secondary 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 Baseline and 6 months Yes
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