Tablet-assisted Training as a Complement Hospital Intervention in Patients With Acute Exacerbations of COPD
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Universidad de Granada
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Forced expiratory volume in the first second (FEV1)
Study Overview
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 a tablet-assisted training in the use of inhalers in patients with COPD including ventilatory re-education and video recordings of the patients themselves.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
CONTROL GROUP
Received the standard medical and pharmacological care provided by the hospital
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.
Intervention: inhaler technique (Device)
Outcomes
Primary Outcomes
Forced expiratory volume in the first second (FEV1)
Time Frame: [Time Frame: baseline, 12 months]
Changes from baseline to postintervention in FEV1vas evaluated by a spirometer.
Secondary Outcomes
- Anxiety-depression level([Time Frame: Baseline, 12 months])
- Cognitive Level([Time Frame: Baseline])
- Dyspnea level([Time Frame: Baseline])
- Physical fitness([Time Frame: baseline, 12 months])
- Knowledge of the Chronic Obstructive Pulmonary Disease([Time Frame: Baseline, 12 months])
- Technique of the inhaler([Time Frame: baseline, 12 months])
- Pressure expiratory force (PEF)([Time Frame: baseline, 12 months])
- Functional independence([Time Frame: Baseline])
- Adhesion to inhalers([Time Frame: Baseline])
Investigators
Marie Carmen Valenza
Principal investigator
Universidad de Granada