Covid19, Mental Health Disorder, Respiratory Disease
Conditions
Keywords
COVID-19, Mental Health, Respiratory Function Tests, Physical and Rehabilitation Medicine, Quality of Life
Brief summary
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
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.
Interventions
OTHERRespiratory and psychological rehabilitation
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.
Sponsors
Johns Hopkins University
London School of Hygiene and Tropical Medicine
Universidad Peruana Cayetano Heredia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six minute walk distance | Change from baseline measure at hospital discharge to week 7 and 12 | Distance walked during 6-minutes (meters) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced Vital Capacity | Change from baseline measure at hospital discharge to week 7 and 12 | Measured in milliliters by dynamic spirometry |
| Quality of life assessed by the Short Form Health Survey (SF-36) questionnaire | Change from baseline measure at hospital discharge to week 7 and 12 | 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 |
| Quality of life assessed by the Health-Related Quality of Life (EQ-5D) questionnaire | Change from baseline measure at hospital discharge to week 7 and 12 | 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. |
| Forced expiratory volume in the first second | Change from baseline measure at hospital discharge to week 7 and 12 | Measured in milliliters by dynamic spirometry |
| Anxious symptoms assessed by the Generalized Anxiety Disorder (GAD-7) questionnaire | Change from baseline measure at hospital discharge to week 7 and 12 | 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. |
| Post-traumatic stress disorder symptomatology assessed by the Impact of Event Scale Revised (IES-R) questionnaire. | Change from baseline measure at hospital discharge to week 7 and 12 | 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). |
| Impact on overall health by respiratory diseases assessed by the score of the St. George's respiratory questionnaire (SGRQ) | Change from baseline measure at hospital discharge to week 7 and 12 | 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) |
| Depressive symptomatology assessed by the Patient Health Questionnaire (PHQ-9) | Change from baseline measure at hospital discharge to week 7 and 12 | 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. |
Countries
Peru
Outcome results
None listed