ClinicalTrials.gov
ClinicalTrials.gov Menu

Education With Inhalers in Patients With COPD Exacerbation

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03337958
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: Ventilatory re-education Not Applicable

Detailed Description:
The importance of this pathology lies not only in its high prevalence, which is expected to increase due to the aging of society but also in its high mortality. In Europe, it is estimated that 50% of adult patients do not use the inhaler correctly. The clinical development of COPD includes periods of stability interspersed with symptomatic exacerbations, which usually involve hospitalization. During these hospitalizations, respiratory symptoms are worsening.Nevertheless, in Europe, it is estimated that 50% of adult patients do not use the inhaler correctly. Thus, it is very important the pharmacological education in this patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized clinical trial.
Masking: Single (Participant)
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Knowledge of the disease [ Time Frame: Baseline, 12 months ]
    Evaluated at baseline by EPOC-Q

  2. Cognitive Level [ Time Frame: Baseline ]
    Cognitive level was assessed using the Montreal Cognitive Assessment (MOCA).

  3. Functional independence [ Time Frame: Baseline ]
    Functional independence was assessed using the Functional Independence Scale (FIM).

  4. 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.

  5. Adhesion to inhalers [ Time Frame: Baseline ]
    Level of adhesion to inhalers was assessed with TAI (Inhaler Adhesion Test).

  6. Dyspnea level [ Time Frame: baseline, 12 months ]
    Perceived perception of dyspnea was collected through the Modified Borg Scale.

  7. 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.

  8. 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.

  9. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria were to be clinically diagnosed of exacerbation of COPD, to possess pharmacological treatment in the form of inhalers.

Exclusion Criteria:

  • Exclusion criteria were inability to provide informed consent, presence of psychiatric or cognitive disorders, neurological disorders, organ failure, cancer or inability to cooperate. Patients who had experienced an exacerbation of prior COPD in less than one month were excluded.

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): NCT03337958


Contacts
Contact: Marie Carmen Valenza, PhD 958 248035 cvalenza@ugr.es

Locations
Spain
Department of Physical Therapy Recruiting
Granada, Spain, 18071
Contact: Marie Carmen Valenza, PhD    958242360    cvalenza@ugr.es   
Principal Investigator: Marie Carmen Valenza, PhD         
Sponsors and Collaborators
Universidad de Granada
Investigators
Principal Investigator: Marie Carmen Valenza, PT, PhD Universidad de Granada

Responsible Party: Marie Carmen Valenza, Principal investigator, Universidad de Granada
ClinicalTrials.gov Identifier: NCT03337958     History of Changes
Other Study ID Numbers: DF0071UG
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marie Carmen Valenza, Universidad de Granada:
Education
Dry Powder Inhalers
Metered Dose Inhalers
Pulmonary Disease
Chronic Obstructive

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases