Effect of Education and Respiratory Rehabilitation on Quality of Life in COPD Patients

NCT03889054 | Unknown

• 1 other identifier: PI-3534
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

In patients with COPD and a history of recent exacerbation, to compare the quality of life after completing a joint program of health education and respiratory rehabilitation with those patients who only receive respiratory rehabilitation. To compare lung function, the distance traveled in the 6-minute walk test and in the test of the shuttle between both groups. Also, to compare between both groups adherence to inhaled treatment, physical activity, and emotional condition. Finally, to compare the number of visits to emergencies and hospitalizations, and on the other hand, the number of mild, moderate and severe exacerbations between both groups

Conditions

COPD

Outcome Measures

Primary Outcomes (3)

• Quality of life after 6 months of education

  To compare the quality of life related to health measured by the Saint George respiratory questionnaire after 6 months between patients who received health education and those who did not receive it.

  Six months

• Quality of life after 6 months of education

  To compare health relate quality of life measured by the EuroQoL questionnaire, after 6 months between patients who received health education and those who did not receive it.

  Six months

• Quality of life after 6 months of education

  To compare health relate quality of life measured by COPD Assessment Test (CAT) after 6 months between patients who received health education and those who did not receive it.

  Six months

Secondary Outcomes (8)

• Pulmonary function after 6 months of education

  Six months

• Distance traveled in the 6-minute walk test and in the shuttle walking test after 6 months of education

  Six months

• Adherence to inhaled treatment after 6 months of education

  Six months

• Physical activity of patients after 6 months of education

  Six months

• Physical activity of patients after 6 months of education

  Six months

Study Arms (2)

Control

NO INTERVENTION

Current clinical management

Structured health education program

ACTIVE COMPARATOR

Patient will be referred to a specific consultation to carry out this intervention.

Behavioral: Education program

Interventions

Education program BEHAVIORAL

The education sessions will be given in 3 opportunities (15-30, 45 and at 90 days from diagnosis of the exacerbation) and it will be individualized. The program will include measures of self-care and self-management recommended in patients with COPD: 1. Plan of action in an exacerbation. 2. Education related to COPD. 3. Information on pharmacological medication. 4. Management of the exacerbation. 5. Management of stress and / or anxiety. 6. Nutritional recommendations. 7. Physical exercise recommendations. 8. Healthy lifestyle recommendations. The first session will last 90 minutes and will be explain according to the contents of the manual "Controlling COPD". A presentation designed for this purpose will be displayed and this manual will be provided to patients to carry out their reading at home. The second and third sessions will last 15 minutes and the purpose will be to resolve doubts.

Also known as: Behavioral management

Structured health education program

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 30 years.
• COPD diagnosis according to GesEPOC criteria (FEV 1 / FVC greater 0.7).
• Smoker or ex-smoker with a cumulative consumption of more than 10 packages per year.
• Exacerbation of COPD diagnosed in the last 15 days.

You may not qualify if:

• Impossibility of obtaining informed consent.
• Osteoarticular, neuromuscular or cognitive limitation.
• Diagnosis of active neoplastic disease, except epidermoid carcinoma of skin.
• Patient with limitation or difficulty to go to the rehabilitation unit to complete the training program.
• Participation in another study / trial in the previous 6 months.
• Have participated in a respiratory rehabilitation program the previous year (12 previous months).

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• GlaxoSmithKline: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Central Study Contacts

Carlos Javier Carpio, Dr

CONTACT

+ 34 647267124; carlinjavier@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized and parallel clinical trial of 66 patients (33 with health education associated with respiratory rehabilitation and 33 only with respiratory rehabilitation). There will be a follow-up of 6 months and 4 visits.

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: March 25, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share