Tablet-assisted Training in Exacerbated COPD
5. december 2018 opdateret af: Marie Carmen Valenza, Universidad de Granada
Tablet-assisted Training as a Complement Hospital Intervention in Patients With Acute Exacerbations of COPD
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 a tablet-assisted training in the use of inhalers in patients with COPD including ventilatory re-education and video recordings of the patients themselves.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
42
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Granada
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Granada., Granada, Spanien, 18071
- Faculty of Health Sciences. University of Granada.
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 100 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Diagnosed of exacerbation of COPD.
- To possess pharmacological treatment in the form of inhalers.
Exclusion Criteria:
- Inability to provide informed consent.
- Presence of psychiatric or cognitive disorders.
- Organ failure or cancer.
- Inability to cooperate.
- Patients who had experienced an exacerbation in the last month.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: KONTROLGRUPPE
Modtog den almindelige medicinske og farmakologiske behandling fra hospitalet
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Eksperimentel: Inhaler technique
The intervention group received the standard medical and pharmacological care provided by the hospital.
In addition, a tablet-assisted training on the use of inhalers, which included an explanation of the use of inhalers together with a ventilatory re-education program.
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The first day of the intervention consisted primarily of 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Forced expiratory volume in the first second (FEV1)
Tidsramme: [Time Frame: baseline, 12 months]
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Changes from baseline to postintervention in FEV1vas evaluated by a spirometer.
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[Time Frame: baseline, 12 months]
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Knowledge of the Chronic Obstructive Pulmonary Disease
Tidsramme: [Time Frame: Baseline, 12 months]
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Evaluated at baseline by Chronic Obstructive Pulmonary Disease Questionnaire (COPD-Q).
COPD knowledge was evaluated using the Chronic Obstructive Pulmonary Disease Knowledge Questionnaire (COPD-Q; Maples, Franks, Ray, Stevens, & Wallace, 2010).
The COPD-Q is a valid, readable, and reliable 13-item (each one score 0 to 3) self-administered true/false questionnaire assessing COPD knowledge in patients with low health literacy skills.
A higher punctuation indicates better results.
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[Time Frame: Baseline, 12 months]
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Cognitive Level
Tidsramme: [Time Frame: Baseline]
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Cognitive level was assessed using the Montreal Cognitive Assessment (MOCA).
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[Time Frame: Baseline]
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Functional independence
Tidsramme: [Time Frame: Baseline]
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Functional independence was assessed using the Functional Independence Mease Scale (FIM).
This scale has 18 items that are grouped into 2 dimensions, 13 motor items, and 5 cognitive items.
The total score range between 18 points (total dependence) to 126 points (Independence completes).
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[Time Frame: Baseline]
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Anxiety-depression level
Tidsramme: [Time Frame: Baseline, 12 months]
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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.
It is composed of 14 items, 7 for anxiety and 7 for depression and higher values are related to higher depression and anxiety.
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[Time Frame: Baseline, 12 months]
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Adhesion to inhalers
Tidsramme: [Time Frame: Baseline]
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Level of adhesion to inhalers was assessed with TAI (Inhaler Adhesion Test).
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[Time Frame: Baseline]
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Dyspnea level
Tidsramme: [Time Frame: Baseline]
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Perceived perception of dyspnea was collected through the Modified Borg Scale.
Patients have to choose a number between 0 ( no dyspnea) to 10 (higher dyspnea).
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[Time Frame: Baseline]
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Physical fitness
Tidsramme: [Time Frame: baseline, 12 months]
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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
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[Time Frame: baseline, 12 months]
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Technique of the inhaler
Tidsramme: [Time Frame: baseline, 12 months]
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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.
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[Time Frame: baseline, 12 months]
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Pressure expiratory force (PEF)
Tidsramme: [Time Frame: baseline, 12 months]
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Changes from baseline to postintervention in PEF were assessed using a peak flow.
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[Time Frame: baseline, 12 months]
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: M. Carmen Valenza, PH MD, Department of Physical Therapy. University of Granada.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. december 2017
Primær færdiggørelse (Faktiske)
23. juni 2018
Studieafslutning (Forventet)
1. april 2019
Datoer for studieregistrering
Først indsendt
4. juli 2018
Først indsendt, der opfyldte QC-kriterier
17. juli 2018
Først opslået (Faktiske)
26. juli 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. december 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. december 2018
Sidst verificeret
1. december 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DF0075UG
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