Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support in Severe COVID-19 Patients
- Conditions
- Covid19Respiratory DiseaseMental Health Disorder
- Interventions
- Other: Respiratory and psychological rehabilitation
- Registration Number
- NCT04649736
- Lead Sponsor
- Universidad Peruana Cayetano Heredia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support Respiratory and psychological rehabilitation 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.
- Primary Outcome Measures
Name Time Method Six minute walk distance Change from baseline measure at hospital discharge to week 7 and 12 Distance walked during 6-minutes (meters)
- Secondary Outcome Measures
Name Time Method 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
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.
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.
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)
Trial Locations
- Locations (1)
Hospital Nacional Cayetano Heredia
🇵🇪Lima, Peru