Education With Inhalers in Patients With COPD Exacerbation
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|ClinicalTrials.gov Identifier: NCT03337958|
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : July 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Device: Ventilatory re-education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized clinical trial.|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of an Educational Intervention in the Management of Inhalers With Tablet and Ventilatory Reeducation: a Randomized Clinical Study|
|Actual Study Start Date :||December 1, 2017|
|Actual Primary Completion Date :||June 15, 2018|
|Estimated Study Completion Date :||July 2018|
No Intervention: CONTROL GROUP
Received the standard medical and pharmacological care provided by the hospital
Experimental: INTERVENTION GROUP
The 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.
Device: Ventilatory re-education
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.
- Respiratory parameters [ Time Frame: baseline, 12 months ]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)
- Knowledge of the disease [ Time Frame: Baseline, 12 months ]Evaluated at baseline by EPOC-Q
- Cognitive Level [ Time Frame: Baseline ]Cognitive level was assessed using the Montreal Cognitive Assessment (MOCA).
- Functional independence [ Time Frame: Baseline ]Functional independence was assessed using the Functional Independence Scale (FIM).
- Anxiety-depression level [ Time Frame: Baseline ]Changes from baseline to postintervention in anxiety and depression measured with the Hospital Anxiety and Depression Scale. Patients are going to complete this questionnaire composed of statements relevant to either generalized anxiety or depression.
- Adhesion to inhalers [ Time Frame: Baseline ]Level of adhesion to inhalers was assessed with TAI (Inhaler Adhesion Test).
- Dyspnea level [ Time Frame: baseline, 12 months ]Perceived perception of dyspnea was collected through the Modified Borg Scale.
- Physical fitness [ Time Frame: baseline, 12 months ]Physical fitness was assessed by performing the five-times-sit-to-stand test. It consists of getting up and sitting five times in a row without a support. The time period in which the exercise is performed is the patient's score with a maximum of 60 seconds.
- Technique of the inhaler [ Time Frame: baseline, 12 months ]The evaluation of the technique of the inhalers was carried out by means of a checklist composed of 5 items. Checked those points that were done correctly obtaining 5 points if the technique that was done correctly.
- Respiratory parameters [ Time Frame: baseline, 12 months ]Changes from baseline to postintervention in respiratory parameters using a spirometer as recommended by the American Thoracic Society. The most important respiratory parameters evaluated are forced vital capacity (FVC), carbon dioxide partial pressure (PCO2) and oxygen partial pressure (PO2).
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): NCT03337958
|Contact: Marie Carmen Valenza, PhD||958 firstname.lastname@example.org|
|Department of Physical Therapy||Recruiting|
|Granada, Spain, 18071|
|Contact: Marie Carmen Valenza, PhD 958242360 email@example.com|
|Principal Investigator: Marie Carmen Valenza, PhD|
|Principal Investigator:||Marie Carmen Valenza, PT, PhD||Universidad de Granada|