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Deprescribing: a Portrait and Out-comes of the Reduction of Polypharmacy in Portugal (DePil17-20)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03283735
Recruitment Status : Unknown
Verified February 2018 by Pedro Augusto Simões, University of Beira Interior.
Recruitment status was:  Not yet recruiting
First Posted : September 14, 2017
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Pedro Augusto Simões, University of Beira Interior

Brief Summary:
This study protocol comprises three phases. The first two phases will be nationwide and aim to evaluate the prevalence and patterns of polypharmacy and assess the barriers and facilitators of deprescribing perceived by older adults, as well as their willingness to be deprescribed and to self-medicate. The third and last phase will be a non-pharmacological randomised clinical study to measure the impact of enablement of older adults in their willingness to be deprescribed and related quality of life.

Condition or disease Intervention/treatment Phase
Polypharmacy Deprescriptions Behavioral: Elderly Enablement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This phase of the study is expected to start in September 2019 and will last for 6 months.

Two groups will be created with a minimum of 190 patients each, one of which will be composed from patients from the region of Aveiro, Coimbra and Guarda and the other from patients from the region of Castelo Branco, Leiria and Viseu. In the intervention group the investigators will give enablement tools and talks with their GPs about how to issue the problem of polypharmacy. The information given in this group will result from the knowledge obtained in phase II in the shape of small leaflets and other information materials to be made according to the best practice, to be given and remembered at scheduled times to the intervention group.

Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Deprescribing: a Portrait and Out-comes of the Reduction of Polypharmacy in Portugal
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Arm Intervention/treatment
Experimental: Elderly Enablement
The investigators will give enablement tools and talks with their GPs about how to issue the problem of polypharmacy.
Behavioral: Elderly Enablement
The information given in this group will result from the knowledge obtained in previous phase of the study in the shape of small leaflets and other information materials to be made according to the best practice, to be given and remembered at scheduled times to the intervention group

No Intervention: Control
This will be the control group.



Primary Outcome Measures :
  1. Willingness to be deprescribed after the intervention with open-questions [ Time Frame: six months ]
    Assess the enablement of older adults while being Deprescribed in the rise of Willingness to be Deprescribed with two open-questions (one to assess the facilitators and the other to assess the barriers) together with their perception of medication (Beliefs about Medicines Questionnaire).


Secondary Outcome Measures :
  1. Quality of life after the intervention with EQ-5D [ Time Frame: six months ]
    Assess the enablement of older adults while being Deprescribed in the rise of their Quality wtih EuroQol Five Dimensions Questionnaire (EQ-5D)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients attending to the primary care consultation in the selected health centres.

Exclusion Criteria:

  • Being acutely unwell in the last three weeks
  • Refuse to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283735


Contacts
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Contact: Pedro Augusto Simões, Master +351968384396 pedro.augusto.simoes@ubi.pt

Sponsors and Collaborators
University of Beira Interior
Investigators
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Principal Investigator: Pedro Augusto Simões, Master University of Beira Interior
  Study Documents (Full-Text)

Documents provided by Pedro Augusto Simões, University of Beira Interior:
Study Protocol  [PDF] September 16, 2017

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pedro Augusto Simões, Doctor, University of Beira Interior
ClinicalTrials.gov Identifier: NCT03283735    
Other Study ID Numbers: UBIMED2017
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pedro Augusto Simões, University of Beira Interior:
Deprescribing
Polypharmacy
Elderly
Enablement
Quality of Life