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

Primary Purpose

Covid19, Respiratory Disease, Mental Health Disorder

Status
Completed
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
Respiratory and psychological rehabilitation
Sponsored by
Universidad Peruana Cayetano Heredia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID-19, Mental Health, Respiratory Function Tests, Physical and Rehabilitation Medicine, Quality of Life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Nacional Cayetano Heredia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Six minute walk distance
Distance walked during 6-minutes (meters)

Secondary Outcome Measures

Forced expiratory volume in the first second
Measured in milliliters by dynamic spirometry
Forced Vital Capacity
Measured in milliliters by dynamic spirometry
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
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.
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.
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.
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).
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)

Full Information

First Posted
November 30, 2020
Last Updated
December 1, 2021
Sponsor
Universidad Peruana Cayetano Heredia
Collaborators
Johns Hopkins University, London School of Hygiene and Tropical Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04649736
Brief Title
Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support in Severe COVID-19 Patients
Acronym
WAYRA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
June 19, 2021 (Actual)
Study Completion Date
June 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Peruana Cayetano Heredia
Collaborators
Johns Hopkins University, London School of Hygiene and Tropical Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Respiratory Disease, Mental Health Disorder
Keywords
COVID-19, Mental Health, Respiratory Function Tests, Physical and Rehabilitation Medicine, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Respiratory and psychological rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Six minute walk distance
Description
Distance walked during 6-minutes (meters)
Time Frame
Change from baseline measure at hospital discharge to week 7 and 12
Secondary Outcome Measure Information:
Title
Forced expiratory volume in the first second
Description
Measured in milliliters by dynamic spirometry
Time Frame
Change from baseline measure at hospital discharge to week 7 and 12
Title
Forced Vital Capacity
Description
Measured in milliliters by dynamic spirometry
Time Frame
Change from baseline measure at hospital discharge to week 7 and 12
Title
Quality of life assessed by the Short Form Health Survey (SF-36) questionnaire
Description
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
Time Frame
Change from baseline measure at hospital discharge to week 7 and 12
Title
Quality of life assessed by the Health-Related Quality of Life (EQ-5D) questionnaire
Description
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.
Time Frame
Change from baseline measure at hospital discharge to week 7 and 12
Title
Depressive symptomatology assessed by the Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
Change from baseline measure at hospital discharge to week 7 and 12
Title
Anxious symptoms assessed by the Generalized Anxiety Disorder (GAD-7) questionnaire
Description
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.
Time Frame
Change from baseline measure at hospital discharge to week 7 and 12
Title
Post-traumatic stress disorder symptomatology assessed by the Impact of Event Scale Revised (IES-R) questionnaire.
Description
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).
Time Frame
Change from baseline measure at hospital discharge to week 7 and 12
Title
Impact on overall health by respiratory diseases assessed by the score of the St. George's respiratory questionnaire (SGRQ)
Description
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)
Time Frame
Change from baseline measure at hospital discharge to week 7 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres G Lescano, PhD, MHS
Organizational Affiliation
Universidad Peruana Cayetano Heredia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Checkley, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stella M Hartinger, MSc, PhD
Organizational Affiliation
Universidad Peruana Cayetano Heredia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Nacional Cayetano Heredia
City
Lima
ZIP/Postal Code
15102
Country
Peru

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results will be published in an indexed peer-review journals.
Citations:
PubMed Identifier
32422177
Citation
Spagnolo P, Balestro E, Aliberti S, Cocconcelli E, Biondini D, Casa GD, Sverzellati N, Maher TM. Pulmonary fibrosis secondary to COVID-19: a call to arms? Lancet Respir Med. 2020 Aug;8(8):750-752. doi: 10.1016/S2213-2600(20)30222-8. Epub 2020 May 15. No abstract available.
Results Reference
background
PubMed Identifier
15947329
Citation
Xie L, Liu Y, Xiao Y, Tian Q, Fan B, Zhao H, Chen W. Follow-up study on pulmonary function and lung radiographic changes in rehabilitating severe acute respiratory syndrome patients after discharge. Chest. 2005 Jun;127(6):2119-24. doi: 10.1378/chest.127.6.2119.
Results Reference
background
PubMed Identifier
29089687
Citation
Das KM, Lee EY, Singh R, Enani MA, Al Dossari K, Van Gorkom K, Larsson SG, Langer RD. Follow-up chest radiographic findings in patients with MERS-CoV after recovery. Indian J Radiol Imaging. 2017 Jul-Sep;27(3):342-349. doi: 10.4103/ijri.IJRI_469_16.
Results Reference
background
PubMed Identifier
32381497
Citation
Mo X, Jian W, Su Z, Chen M, Peng H, Peng P, Lei C, Chen R, Zhong N, Li S. Abnormal pulmonary function in COVID-19 patients at time of hospital discharge. Eur Respir J. 2020 Jun 18;55(6):2001217. doi: 10.1183/13993003.01217-2020. Print 2020 Jun.
Results Reference
background
PubMed Identifier
32411496
Citation
Yang LL, Yang T. Pulmonary rehabilitation for patients with coronavirus disease 2019 (COVID-19). Chronic Dis Transl Med. 2020 May 14;6(2):79-86. doi: 10.1016/j.cdtm.2020.05.002. eCollection 2020 Jun.
Results Reference
background
PubMed Identifier
32379637
Citation
Liu K, Zhang W, Yang Y, Zhang J, Li Y, Chen Y. Respiratory rehabilitation in elderly patients with COVID-19: A randomized controlled study. Complement Ther Clin Pract. 2020 May;39:101166. doi: 10.1016/j.ctcp.2020.101166. Epub 2020 Apr 1.
Results Reference
background
PubMed Identifier
31723900
Citation
Jang MH, Shin MJ, Shin YB. Pulmonary and Physical Rehabilitation in Critically Ill Patients. Acute Crit Care. 2019 Feb;34(1):1-13. doi: 10.4266/acc.2019.00444. Epub 2019 Feb 28.
Results Reference
background
PubMed Identifier
36108135
Citation
Soriano-Moreno AN, Flores EC, Hartinger SM, Mallma CY, Diaz AA, Gianella GE, Galvez-Buccollini JA, Coico-Lama AH, Malaga G, Fajardo E, Paredes-Angeles R, Otazu-Alfaro S, Lescano AG, Checkley W; WAYRA Trial Investigators. Home-Based Respiratory Physiotherapy and Telephone-Based Psychological Support for COVID-19 Survivors in Peru: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 24;11(10):e36001. doi: 10.2196/36001.
Results Reference
derived

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

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