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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02866799 |
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Date of registration:
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05/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Multi-PAP: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy
Multi-PAP |
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Scientific title:
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Effectiveness of an Intervention for Improving Drug Prescription in Primary Care Patients With Multimorbidity and Polypharmacy: Study Protocol of a Cluster Randomized Clinical Trial (Multi-PAP Project) |
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Date of first enrolment:
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November 2016 |
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Target sample size:
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593 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02866799 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Double (Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Spain
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Contacts
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Name:
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Isabel Del Cura-González, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gerencia de Atención Primaria, Madrid |
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Name:
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Alexandra Prados-Torres, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Aragonés de Ciencias de la Salud (IACS) |
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Name:
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Daniel Prados-Torres, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Servicio Andaluz de Salud (Andaluz Health Service) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients 65-74 years of age with multimorbidity (3 or more chronic diseases) and
polypharmacy (5 or more drugs taken for at least three months).
- Informed consent.
Exclusion Criteria:
- Institutionalized patient at nursing homes or similar
- Life expectancy < 12 months
Age minimum:
65 Years
Age maximum:
74 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Polypharmacy
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Other Diagnoses, Comorbidities, and Complications
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Multimorbidity
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Intervention(s)
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Other: Multi-PAP
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Other: Usual care
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Primary Outcome(s)
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Medication Appropriateness Index (MAI) score
[Time Frame: Change from baseline MAI score at 6 months]
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Secondary Outcome(s)
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Medication Appropriateness Index (MAI) score
[Time Frame: Change from baseline MAI score at 12 months]
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Patient perception of shared decision-making
[Time Frame: Baseline and at six 6 months and at 12 months]
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Use of health services
[Time Frame: at six 6 months and at 12 months]
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Haynes-Sackett test
[Time Frame: Baseline, at six 6 months and at 12 months]
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Morisky-Green questionnaire
[Time Frame: Baseline, at six 6 months and at 12 months]
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Euroqol 5D-5L questionnaire
[Time Frame: Baseline, at six 6 months and at 12 months]
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Medication safety
[Time Frame: at six 6 months and at 12 months]
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Secondary ID(s)
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PI: 15/00572,15/00276,15/00996
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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