NCT01291966

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
Last Updated

February 9, 2011

Status Verified

December 1, 2010

First QC Date

January 26, 2011

Last Update Submit

February 8, 2011

Conditions

Keywords

medication errorsPatient Compliancepatient safetypolypharmacy

Outcome Measures

Primary Outcomes (1)

  • medication errors in the patients

    Medication errors before and after the intervention in each group

    Baseline, 1, 3 and 6 months

Secondary Outcomes (1)

  • Percentage of adherence

    Baseline and 6 months

Study Arms (1)

Motivational interview

EXPERIMENTAL
Behavioral: Motivational interview

Interventions

Also known as: Counseling, Patient-centered method
Motivational interview

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients with polypharmacy (5 or more medicines)
  • That detects to them a problem of Therapeutic Adherence
  • That agree to take part in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidad Docente de Medicina Familiar y Comunitaria

Córdoba, Córdoba, 14011, Spain

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Medication AdherencePatient Compliance

Interventions

Motivational InterviewingCounseling

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesCommunity Health Services

Study Officials

  • Luis A Perula, PH D

    Andalusian Health Service

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 26, 2011

First Posted

February 9, 2011

Study Start

January 1, 2010

Study Completion

September 1, 2010

Last Updated

February 9, 2011

Record last verified: 2010-12

Locations