Task-specific Training for Patients With Acute Exacerbation of COPD (COPD)

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 Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Behavioral: Task-specific training; Other: Usual care

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie Carmen Valenza, Chair; Phone Number: +34 958248035; Email: cvalenza@ugr.es

Study Locations

• Spain
  • Granada
    • Granada., Granada, Spain, 18071
      • Faculty of Health Sciences. University of Granada.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual care	Other: Usual care; 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.
Experimental: Task-specific training	Behavioral: Task-specific training; 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.; Other: Usual care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced expiratory volume in the first second (FEV1)	Changes from baseline to postintervention in FEV1vas evaluated by a spirometer.	Baseline and hospital discharge
Pressure expiratory force (PEF)	Changes from baseline to post-intervention in PEF were assessed using a peak flow	Baseline and hospital discharge
Pressure inspiratory force (PIF)	Changes from baseline to post-intervention in PEF were assessed using a check-dial.	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.	Baseline and hospital discharge
Postural evaluation	Using photometry with anatomical landmarks established in this population	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.	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.	Baseline, hospital discharge, 1 month, 3 months and 6 months

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Study Director: Marie Carmen Valenza, Chair, Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2024
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): August 15, 2024

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Estimated): January 25, 2024

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: DF0101UG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No