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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prevalence of Altered Pulmonary Function Post-infection by COVID-19 and Impact of Participation in a Pilot Program of Comprehensive Rehabilitation in the Short and Medium-term

Conditions
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Covid19, Respiratory Disease, Mental Health Disorder

Intervention / Treatment
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* Other: Respiratory and psychological rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support<br>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. | Other: Respiratory and psychological rehabilitation<br>* Respiratory rehabilitation consists of 12 sessions of respiratory and physical exercises that patients perform at home with the help of a physiotherapist. Sessions have 1 hour of duration and are performing twice a week. Exercises include (1) Training of the respiratory muscles through pursed-lip breaths. (2) Effective cough exercises. (3) Diaphragmatic contractions in a supine position with a lightweight placed on the anterior abdominal wall. (4) Stretching exercise of extremities and the back. The psychological support consists of 1 session to make the psychological history of the participant, and 6 sessions of emotion-centered problem-solving therapy, with cognitive-behavioral components and psychological management of emergencies and crises. These sessions have a 1-hour duration and are telephone-provided once a week by psychologists following the guidelines of the Inter-Agency Standing Committee on Mental Health and Psychosocial Support in Humanitarian and Disaster Emergencies.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six minute walk distance | Distance walked during 6-minutes (meters) | Change from baseline measure at hospital discharge to week 7 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in the first second | Measured in milliliters by dynamic spirometry | Change from baseline measure at hospital discharge to week 7 and 12 | 
| Forced Vital Capacity | Measured in milliliters by dynamic spirometry | Change from baseline measure at hospital discharge to week 7 and 12 | 
| Quality of life assessed by the Short Form Health Survey (SF-36) questionnaire | The SF-36 questionnaire consists of 36 items, which are used to calculate eight subscales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The first four scores can be summed to create the physical composite score (PCS), while the last four can be summed to create the mental composite score (MCS). Scores for the SF-36 scales range between 0 and 100, with higher scores indicating a better health-related quality of life | Change from baseline measure at hospital discharge to week 7 and 12 | 
| Quality of life assessed by the Health-Related Quality of Life (EQ-5D) questionnaire | EQ-5D is a standardized tool for the assessment of quality of life in 5 different dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression). Possible scores range from 1 (No problem) to 3 (Extreme problems) and each dimension are evaluated individually. | Change from baseline measure at hospital discharge to week 7 and 12 | 
| Depressive symptomatology assessed by the Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire-9 (PHQ-9) consists of nine items covering the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for major depression scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 27. A greater score means worse depressive symptoms. | Change from baseline measure at hospital discharge to week 7 and 12 | 
| Anxious symptoms assessed by the Generalized Anxiety Disorder (GAD-7) questionnaire | The Generalized Anxiety Disorder-7 (GAD-7) consists of seven items covering the DSM-IV criteria for GAD scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 21. A higher score means worse anxiety symptoms. | Change from baseline measure at hospital discharge to week 7 and 12 | 
| Post-traumatic stress disorder symptomatology assessed by the Impact of Event Scale Revised (IES-R) questionnaire. | IES-R consists of 21 items covering the DSM-IV criteria for PTSD. Score varying from 0 (no risk of post traumatic stress) to 88 (highest risk of post traumatic stress). | Change from baseline measure at hospital discharge to week 7 and 12 | 
| Impact on overall health by respiratory diseases assessed by the score of the St. George's respiratory questionnaire (SGRQ) | The SGRQ scores from 0 (no impairment of quality of life by respiratory diseases/symptoms) to 100 (highest impairment of quality of life by respiratory diseases/symptoms) | Change from baseline measure at hospital discharge to week 7 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Mental Health, Respiratory Function Tests, Physical and Rehabilitation Medicine, Quality of Life