Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support in Severe COVID-19 Patients (WAYRA)

Universidad Peruana Cayetano Heredia

Status: Completed

Conditions: Respiratory Disease; Mental Health Disorder; Covid19

Treatments: Other: Respiratory and psychological rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04649736

202852

Details and patient eligibility

About

Some COVID-19 survivors may have respiratory and mental health sequelae, especially those who required hospitalization. The investigators hypothesize that the participation of a rehabilitation program composite by home-based respiratory physiotherapy and telephone-based psychological support will improve respiratory function, quality of life, and psychological status in severe COVID-19 patients.

Full description

In Peru, almost one million persons have survived COVID-19 and initial reports indicate that could exist long-term health damage. This study aims to assess the efficacy of a 6-week rehabilitation program following hospital discharge for patients who had severe COVID-19. The program includes 12 sessions of home-based respiratory therapy that the patient will carry out with a physiotherapist and 7 sessions of telephone-based psychological support bring by a psychologist.

Enrollment: 108 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 75 years
• Be discharged from hospitalization with a COVID-19 confirmed diagnosis
• Be able of understanding study procedures
• Be able to give informed consent
• Required oxygen flow greater than 6lt/min or through a high flow device at any time during hospitalization
• Have been evaluated by the rehabilitation service at least once during the hospitalization

Exclusion criteria

• Contraindications to six-minute walk test
• Contraindications to spirometry
• Complications during the baseline six-minute walk test
• Have neurological pathology, neuropathy, limb dysfunction, or other underlying physical disability that makes physical exercise impossible
• Be pregnant or breastfeeding
• Do not have access to the Internet or a telephone line
• Have previous lung diseases like asthma, COPD, fibrosis, or tuberculosis
• Moderate or severe heart disease (Grade III or IV, New York Heart Association)
• Have had another severe disease in the last six months
• Severe depression or suicidal intention
• Be taking any medication for depression, anxiety, or other medication prescribed by a psychiatrist prior to the onset of a COVID-19 condition
• Have cognitive impairment or sensory disturbance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support

Experimental group

Description:

Participants in the intervention arm will receive the conventional care given by the hospital that consists of discharged recommendations and a follow-up plan through telephone calls to verify treatment compliance. Discharged recommendations include performing respiratory exercises at home and medication. There is no plan for diagnosing mental illness or a strategy for respiratory o psychological rehabilitation at the hospital. Additionally, these participants will receive the intervention program that involves home-based respiratory physiotherapy and telephone-based psychological support for 6 weeks.

Treatment:

Other: Respiratory and psychological rehabilitation

Control

No Intervention group

Description:

Participants in the control arm will only receive the conventional care given by the hospital that consists of discharged recommendations and a follow-up plan through telephone calls to verify treatment compliance. Discharged recommendations include performing respiratory exercises at home and medication. There is no plan for diagnosing mental illness or a strategy for respiratory o psychological rehabilitation at the hospital.