Education With Inhalers in Patients With COPD Exacerbation
Evaluation of an Educational Intervention in the Management of Inhalers With Tablet and Ventilatory Reeducation: a Randomized Clinical Study
1 other identifier
interventional
15
1 country
1
Brief Summary
Chronic obstructive pulmonary disease (COPD) is a public health problem with great morbidity. The main therapeutic strategy is inhalers. The objective of this study is to determine the efficacy of an educational intervention in the use of inhalers in patients with COPD including ventilatory re-education and video recordings of the patients themselves.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease
Started Dec 2017
Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease
1 active site
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
First Submitted
Initial submission to the registry
September 20, 2017
CompletedFirst Posted
Study publicly available on registry
November 9, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedJuly 12, 2018
July 1, 2018
7 months
September 20, 2017
July 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Respiratory parameters
Changes from baseline to postintervention in respiratory parameters using a spirometer. The most important respiratory parameters evaluated is forced expiratory volume in the first second (FEV1)
baseline, 12 months
Secondary Outcomes (9)
Knowledge of the disease
Baseline, 12 months
Cognitive Level
Baseline
Functional independence
Baseline
Anxiety-depression level
Baseline
Adhesion to inhalers
Baseline
- +4 more secondary outcomes
Study Arms (2)
CONTROL GROUP
NO INTERVENTIONReceived the standard medical and pharmacological care provided by the hospital
INTERVENTION GROUP
EXPERIMENTALThe group received the standard medical and pharmacological care provided by the hospital. In addition, an educational program on the use of inhalers, which included an explanation of the use of inhalers together with a ventilatory re-education program, furthermore, the technique of inhaler use was trained.
Interventions
The first day of intervention consisted primarily in ventilatory re-education. During the realization of the technique he was videotaped with a Tablet so that later the patient could be seen and on the video to be able to give him the guidelines for the correction. On the second and third day of the intervention, ventilation re-education was performed and the inhalation technique was subsequently trained.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Physical Therapy
Granada, 18071, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie Carmen Valenza, PT, PhD
Universidad de Granada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
September 20, 2017
First Posted
November 9, 2017
Study Start
December 1, 2017
Primary Completion
June 15, 2018
Study Completion
July 1, 2018
Last Updated
July 12, 2018
Record last verified: 2018-07