Chronic Obstructive Pulmonary DiseaseNCT03601403
Tablet-assisted Training in Exacerbated COPD
A study testing inhaler technique in people with Chronic Obstructive Pulmonary Disease, run by Universidad de Granada at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- inhaler technique
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2017to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed of exacerbation of COPD.
- To possess pharmacological treatment in the form of inhalers.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Health Sciences. University of Granada.
Granada, Granada, 18071
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- inhaler technique
- Keywords
- Education, Dry Powder Inhalers, Metered Dose Inhalers, Pulmonary Disease, Chronic Obstructive
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaler techniqueDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | No intervention | Received the standard medical and pharmacological care provided by the hospital |
| Inhaler technique | Experimental | 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. Receives: Device: inhaler technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in the first second (FEV1)
Changes from baseline to postintervention in FEV1vas evaluated by a spirometer.
Measured: [Time Frame: baseline, 12 months]
Secondary outcomes (9)
Knowledge of the Chronic Obstructive Pulmonary Disease
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.
Measured: [Time Frame: Baseline, 12 months]
Cognitive Level
Cognitive level was assessed using the Montreal Cognitive Assessment (MOCA).
Measured: [Time Frame: Baseline]
Functional independence
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).
Measured: [Time Frame: Baseline]
Anxiety-depression level
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.
Measured: [Time Frame: Baseline, 12 months]
Adhesion to inhalers
Level of adhesion to inhalers was assessed with TAI (Inhaler Adhesion Test).
Measured: [Time Frame: Baseline]
Dyspnea level
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).
Measured: [Time Frame: Baseline]
Physical fitness
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
Measured: [Time Frame: baseline, 12 months]
Technique of the inhaler
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.
Measured: [Time Frame: baseline, 12 months]
Pressure expiratory force (PEF)
Changes from baseline to postintervention in PEF were assessed using a peak flow.
Measured: [Time Frame: baseline, 12 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Dec 2017
- Primary completion23 Jun 2018
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
- Investigators
- M. Carmen Valenza, PH MD, Principal investigator, Department of Physical Therapy. University of Granada.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601403
- Sponsor's protocol ID
- DF0075UG
- Status last verified
- Dec 2018
- First submitted
- 4 Jul 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tablet-assisted Training as a Complement Hospital Intervention in Patients With Acute Exacerbations of COPD
- ClinicalTrials.gov ID
- NCT03601403
- Acronym / sponsor ID
- DF0075UG
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Education, Dry Powder Inhalers, Metered Dose Inhalers, Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 23 Jun 2018 (actual)
- Study completion
- Apr 2019 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | No intervention | –Received the standard medical and pharmacological care provided by the hospital |
| Inhaler technique | Experimental | Device: inhaler techniqueThe 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed of exacerbation of COPD.
- To possess pharmacological treatment in the form of inhalers.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inhaler techniqueThe 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. | Device | Inhaler technique |
Primary outcome
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.
9 secondary outcomes
Knowledge of the Chronic Obstructive Pulmonary Disease
Time frame: [Time Frame: Baseline, 12 months]
Cognitive Level
Time frame: [Time Frame: Baseline]
Functional independence
Time frame: [Time Frame: Baseline]
Anxiety-depression level
Time frame: [Time Frame: Baseline, 12 months]
Adhesion to inhalers
Time frame: [Time Frame: Baseline]
Dyspnea level
Time frame: [Time Frame: Baseline]
Physical fitness
Time frame: [Time Frame: baseline, 12 months]
Technique of the inhaler
Time frame: [Time Frame: baseline, 12 months]
Pressure expiratory force (PEF)
Time frame: [Time Frame: baseline, 12 months]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Carmen Valenza, PH MD principal investigator
Department of Physical Therapy. University of Granada.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inhaler technique in people with Chronic Obstructive Pulmonary Disease, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume in the first second (FEV1) (time frame: [Time Frame: baseline, 12 months]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.