Task-specific Training for Patients With Acute Exacerbation of COPD

NCT06224075 | Unknown

• 1 other identifier: DF0101UG
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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

  Baseline, hospital discharge, 1 month, 3 months and 6 months

Secondary Outcomes (7)

• Forced expiratory volume in the first second (FEV1)

  Baseline and hospital discharge

• Pressure expiratory force (PEF)

  Baseline and hospital discharge

• Pressure inspiratory force (PIF)

  Baseline and hospital discharge

• Technique of the inhaler

  Baseline and hospital discharge

• Postural evaluation

  Baseline and hospital discharge

Study Arms (2)

Task-specific training

EXPERIMENTAL

Behavioral: Task-specific training; Other: Usual care

Usual care

OTHER

Other: Usual care

Interventions

Task-specific training BEHAVIORAL

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.

Task-specific training

Usual care OTHER

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.

Task-specific training; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Faculty of Health Sciences. University of Granada.

Granada, Granada, 18071, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie Carmen Valenza, Chair

  Universidad de Granada

  STUDY DIRECTOR

Central Study Contacts

Marie Carmen Valenza, Chair

CONTACT

958248035; cvalenza@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Physiotherapy

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 25, 2024
• Study Start: January 15, 2024
• Primary Completion: July 15, 2024
• Study Completion: August 15, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)