Tablet-assisted Training in Exacerbated COPD
5 december 2018 uppdaterad av: 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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
42
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Granada
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Granada., Granada, Spanien, 18071
- Faculty of Health Sciences. University of Granada.
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 100 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: KONTROLLGRUPP
Fick den vanliga medicinska och farmakologiska vård som sjukhuset tillhandahåller
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Forced expiratory volume in the first second (FEV1)
Tidsram: [Time Frame: baseline, 12 months]
|
Changes from baseline to postintervention in FEV1vas evaluated by a spirometer.
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[Time Frame: baseline, 12 months]
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Knowledge of the Chronic Obstructive Pulmonary Disease
Tidsram: [Time Frame: Baseline, 12 months]
|
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
Tidsram: [Time Frame: Baseline]
|
Cognitive level was assessed using the Montreal Cognitive Assessment (MOCA).
|
[Time Frame: Baseline]
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Functional independence
Tidsram: [Time Frame: Baseline]
|
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
Tidsram: [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
Tidsram: [Time Frame: Baseline]
|
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
Tidsram: [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
Tidsram: [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
Tidsram: [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)
Tidsram: [Time Frame: baseline, 12 months]
|
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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: M. Carmen Valenza, PH MD, Department of Physical Therapy. University of Granada.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 december 2017
Primärt slutförande (Faktisk)
23 juni 2018
Avslutad studie (Förväntat)
1 april 2019
Studieregistreringsdatum
Först inskickad
4 juli 2018
Först inskickad som uppfyllde QC-kriterierna
17 juli 2018
Första postat (Faktisk)
26 juli 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 december 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 december 2018
Senast verifierad
1 december 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DF0075UG
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