Pulmonary Disease, Chronic ObstructiveCOPDNCT06224075
Task-specific Training for Patients With Acute Exacerbation of COPD
A study testing Task-specific training in people with Pulmonary Disease, Chronic Obstructive, run by Universidad de Granada at 1 site in Spain.
Trial summary
Patients with Chronic Obstructive Pulmonary Disease (COPD) experience a progressive deterioration in their quality of life. Task-specific training is a type of approach focused on chronic patients that allows the acquisition of new skills or improvement of lost skills. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Task-specific training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2024to 15 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized for acute exacerbation of COPD.
- Over 18 years of age.
- Who wish to participate in the study.
- Who sign the informed consent form.
Who cannot join
- Patients with inability to provide informed consent.
- Presence of psychiatric or cognitive disorders, organ failure, cancer and/or inability to cooperate.
- Patients who had experienced exacerbation of COPD in the previous month were also excluded.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Health Sciences. University of Granada.
Granada, Granada, 18071
About this study
Patients with Chronic Obstructive Pulmonary Disease (COPD) experience a progressive deterioration in their quality of life. Task-specific training is a type of approach focused on chronic patients that allows the acquisition of new skills or improvement of lost skills. The overall objective of this project is to evaluate the effectiveness of a task-specific training program during hospitalization of patients with acute exacerbation of COPD. A randomized clinical trial will be conducted in patients hospitalized for COPD. Participants after signing informed consent will be randomized between the control group (standard treatment) and the intervention group (task-specific training program in addition to standard treatment). The task-specific training program is a multidisciplinary program divided into three blocks where specific tasks will be performed on symptom education, education of activities of daily living and improvement of physical capacity with the aim of reinforcing skills necessary for the self-management of COPD patients in the short, medium and long term.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Task-specific training, Usual care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-specific trainingBehavioural
Participants in the intervention group will receive the treatment established for the control group and nursing care based on task-specific training. The intervention was designed with the aim of improving inhaler management in COPD patients. The content of the tasks will be adapted to the different types of devices present in the patient's therapeutic regimen, mainly pressurized cartridge and dry powder devices.
In order to carry out the intervention, several tasks related to education, assessment and/or training will be established with the aim of improving the ability to use the prescribed inhalers. The tasks have been classified into 3 blocks: technique execution, device cleaning and medication administration.
Usual careOther
All patients will receive standard treatment during their hospital stay (medical and pharmacological care). This treatment will include steroids, antibiotics, inhaled bronchodilators and oxygen therapy. In addition, during hospitalization they may receive diuretics, anticoagulants and cardiovascular treatments if necessary.
| Study group | Role | What they receive |
|---|---|---|
| Task-specific training | Experimental | Not described Receives: Behavioral: Task-specific training; Other: Usual care |
| Usual care | Other | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Borg Scale
the perceived dyspnoea is measure with the Borg Scale. This scale range from 0-10 where higher value indicate worse state, more dyspnoea.
Measured: Baseline, hospital discharge, 1 month, 3 months and 6 months
COPD Assessment Test (CAT)
It consists of eight questions covering cough, phlegm, chest tightness, breathlessness, activity limitations at home, confidence leaving home, sleep and energy. The items are graded from 0 to 5, giving a total score range from 0 to 40, where lower scores indicate fewer symptoms and a better quality of life.
Measured: Baseline, hospital discharge, 1 month, 3 months and 6 months
EuroQol-5D (EQ-5D)
Changes in quality of life were measured using the Euroqol 5dimensions which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. It also includes a visual analogue scale to report the health status from 0 to 100. Higher score indicate higher quality of life. Better.
Measured: Baseline, hospital discharge, 1 month, 3 months and 6 months
Chronic Obstructive Pulmonary Disease Knowledge Questionnaire (COPD-Q)
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: Baseline, 1 months and 6 months
Test of Adherence to Inhalers (TAI)
This questionnaire has two forms, the first type being a 10-item to identify the patient's adherence status to inhalers. There are 2 other questions to check the degree of compliance. The 10-item form is scored from 1 (the poorest) to 5(the best) for each item, and the total score of the questionnaire ranges from 10 to 50 (a score of 45 or less indicates poor adherence, 46 to 49 is intermediate adherence, and 50 indicates good adherence
Measured: Baseline, hospital discharge, 1 month, 3 months and 6 months
Secondary outcomes (7)
Forced expiratory volume in the first second (FEV1)
Changes from baseline to postintervention in FEV1vas evaluated by a spirometer.
Measured: Baseline and hospital discharge
Pressure expiratory force (PEF)
Changes from baseline to post-intervention in PEF were assessed using a peak flow
Measured: Baseline and hospital discharge
Pressure inspiratory force (PIF)
Changes from baseline to post-intervention in PEF were assessed using a check-dial.
Measured: Baseline and hospital discharge
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: Baseline and hospital discharge
Postural evaluation
Using photometry with anatomical landmarks established in this population
Measured: Baseline and hospital discharge
Patient activation measure (PAM)
The Patient Activation Measure-13 (PAM-13) is a concise assessment tool designed to evaluate an individual's knowledge, skills, and confidence in managing their own healthcare. Comprising 13 items, this self-report questionnaire helps healthcare professionals and researchers gauge a patient's level of activation and engagement in their healthcare journey. Respondents answer a series of questions related to their health-related knowledge, confidence in managing their health, and their proactivity in seeking healthcare information and making informed decisions. The score range from 13 to 52. Higher PAM-13 scores indicate a higher level of patient activation, which is often associated with better health outcomes and more effective self-management of chronic conditions.
Measured: Baseline, 1 month and 6 months
Fatigue Severity
The perceived pain and Fatigue are measured with a Visual Analogue Scale from 0 to10, where 0 indicate no presence of pain or fatigue, and 10 indicate worst fatigue or pain.
Measured: Baseline, hospital discharge, 1 month, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start15 Jan 2024 (estimated)
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 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
- Marie Carmen Valenza, Chair, Study director, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224075
- Sponsor's protocol ID
- DF0101UG
- Acronym
- COPD
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task-specific Training for Patients With Acute Exacerbation of COPD
- ClinicalTrials.gov ID
- NCT06224075
- Acronym / sponsor ID
- COPD / DF0101UG
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 25 Jan 2024 (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.
Patients with Chronic Obstructive Pulmonary Disease (COPD) experience a progressive deterioration in their quality of life. Task-specific training is a type of approach focused on chronic patients that allows the acquisition of new skills or improvement of lost skills. The overall objective of this project is to evaluate the effectiveness of a task-specific training program during hospitalization of patients with acute exacerbation of COPD. A randomized clinical trial will be conducted in patients hospitalized for COPD. Participants after signing informed consent will be randomized between the control group (standard treatment) and the intervention group (task-specific training program in addition to standard treatment). The task-specific training program is a multidisciplinary program divided into three blocks where specific tasks will be performed on symptom education, education of activities of daily living and improvement of physical capacity with the aim of reinforcing skills necessary for the self-management of COPD patients in the short, medium and long term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Task-specific training | Experimental | Behavioral: Task-specific training, Other: Usual care |
| Usual care | Other | Other: Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients hospitalized for acute exacerbation of COPD.
- Over 18 years of age.
- Who wish to participate in the study.
- Who sign the informed consent form.
Key exclusion criteria (3 listed)
- Patients with inability to provide informed consent.
- Presence of psychiatric or cognitive disorders, organ failure, cancer and/or inability to cooperate.
- Patients who had experienced exacerbation of COPD in the previous month were also excluded.
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 |
|---|---|---|
| Task-specific trainingParticipants in the intervention group will receive the treatment established for the control group and nursing care based on task-specific training. The intervention was designed with the aim of improving inhaler management in COPD patients. The content of the tasks will be adapted to the different types of devices present in the patient's therapeutic regimen, mainly pressurized cartridge and dry powder devices. In order to carry out the intervention, several tasks related to education, assessment and/or training will be established with the aim of improving the ability to use the prescribed inhalers. The tasks have been classified into 3 blocks: technique execution, device cleaning and medication administration. | Behavioural | Task-specific training |
| Usual careAll patients will receive standard treatment during their hospital stay (medical and pharmacological care). This treatment will include steroids, antibiotics, inhaled bronchodilators and oxygen therapy. In addition, during hospitalization they may receive diuretics, anticoagulants and cardiovascular treatments if necessary. | Other | Task-specific training, Usual care |
Primary outcome
Modified Borg Scale
Time frame: Baseline, hospital discharge, 1 month, 3 months and 6 months
the perceived dyspnoea is measure with the Borg Scale. This scale range from 0-10 where higher value indicate worse state, more dyspnoea.
COPD Assessment Test (CAT)
Time frame: Baseline, hospital discharge, 1 month, 3 months and 6 months
It consists of eight questions covering cough, phlegm, chest tightness, breathlessness, activity limitations at home, confidence leaving home, sleep and energy. The items are graded from 0 to 5, giving a total score range from 0 to 40, where lower scores indicate fewer symptoms and a better quality of life.
EuroQol-5D (EQ-5D)
Time frame: Baseline, hospital discharge, 1 month, 3 months and 6 months
Changes in quality of life were measured using the Euroqol 5dimensions which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. It also includes a visual analogue scale to report the health status from 0 to 100. Higher score indicate higher quality of life. Better.
Chronic Obstructive Pulmonary Disease Knowledge Questionnaire (COPD-Q)
Time frame: Baseline, 1 months and 6 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.
Test of Adherence to Inhalers (TAI)
Time frame: Baseline, hospital discharge, 1 month, 3 months and 6 months
This questionnaire has two forms, the first type being a 10-item to identify the patient's adherence status to inhalers. There are 2 other questions to check the degree of compliance. The 10-item form is scored from 1 (the poorest) to 5(the best) for each item, and the total score of the questionnaire ranges from 10 to 50 (a score of 45 or less indicates poor adherence, 46 to 49 is intermediate adherence, and 50 indicates good adherence
7 secondary outcomes
Forced expiratory volume in the first second (FEV1)
Time frame: Baseline and hospital discharge
Pressure expiratory force (PEF)
Time frame: Baseline and hospital discharge
Pressure inspiratory force (PIF)
Time frame: Baseline and hospital discharge
Technique of the inhaler
Time frame: Baseline and hospital discharge
Postural evaluation
Time frame: Baseline and hospital discharge
Patient activation measure (PAM)
Time frame: Baseline, 1 month and 6 months
Fatigue Severity
Time frame: Baseline, hospital discharge, 1 month, 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Marie Carmen Valenza, Chair study director
Universidad de 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 Task-specific training in people with Pulmonary Disease, Chronic Obstructive, 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 4 inclusion and 3 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 25 Jan 2024. 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?
Contact Marie Carmen Valenza, Chair (958248035 ext. +34, cvalenza@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Borg Scale (time frame: Baseline, hospital discharge, 1 month, 3 months and 6 months). The study lists 5 primary outcomes in all. 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 25 Jan 2024.