Home-Based Respiratory Physiotherapy and Telephone-Based Psychological Support for COVID-19 Survivors in Peru: Protocol for a Randomized Controlled Trial.
COVID-19
clinical trial
mental health
psychiatric rehabilitation
pulmonary rehabilitation
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
24 10 2022
24 10 2022
Historique:
received:
16
02
2022
accepted:
02
08
2022
revised:
19
07
2022
pubmed:
16
9
2022
medline:
16
9
2022
entrez:
15
9
2022
Statut:
epublish
Résumé
Both pulmonary and mental health are affected following hospitalization for COVID-19 pneumonia. Pulmonary rehabilitation therapy has demonstrated benefits in improving mental health, but no validated combined programs that include mental health have been proposed. This article presents the design of a trial that aimed to assess whether the participation in a combined rehabilitation program that includes home-based respiratory physiotherapy and telephone-based psychological support is associated with a greater improvement of pulmonary and mental health outcomes 7-12 weeks after COVID-19 hospitalization discharge compared with posthospital usual care provided by a public Peruvian hospital. WAYRA (the word for air in the Quechua language) was an open-label, unblinded, two-arm randomized controlled trial. We recruited 108 participants aged 18-75 years who were discharged from the hospital after COVID-19 pneumonia that required >6 liters/minute of supplemental oxygen during treatment. Participants were randomly assigned at a 1:1 ratio to receive the combined rehabilitation program or usual posthospital care provided by a public Peruvian hospital. The intervention consisted of 12 at-home respiratory rehabilitation sessions and 6 telephone-based psychological sessions. The primary outcome was the 6-minute walk distance. Secondary outcomes included lung function, mental health status (depression, anxiety, and trauma), and quality of life. Outcomes were assessed at baseline (before randomization) and at 7 and 12 weeks after hospital discharge to assess the difference between arms. This study was funded by the Peruvian National Council of Science Technology and Technology Innovation in July 2020. Ethics approval was obtained on September 2, 2020. Recruitment and data collection occurred between October 2020 and June 2021. Results are expected to be published by the end of 2022. WAYRA was the first randomized controlled trial evaluating combined pulmonary-mental health rehabilitation for hospitalized COVID-19 survivors in resource-limited settings, potentially providing a foundation for the cost-effective scale-up of similar multidisciplinary rehabilitation programs. ClinicalTrials.gov NCT04649736; https://clinicaltrials.gov/ct2/show/NCT04649736. RR1-10.2196/36001.
Sections du résumé
BACKGROUND
Both pulmonary and mental health are affected following hospitalization for COVID-19 pneumonia. Pulmonary rehabilitation therapy has demonstrated benefits in improving mental health, but no validated combined programs that include mental health have been proposed.
OBJECTIVE
This article presents the design of a trial that aimed to assess whether the participation in a combined rehabilitation program that includes home-based respiratory physiotherapy and telephone-based psychological support is associated with a greater improvement of pulmonary and mental health outcomes 7-12 weeks after COVID-19 hospitalization discharge compared with posthospital usual care provided by a public Peruvian hospital.
METHODS
WAYRA (the word for air in the Quechua language) was an open-label, unblinded, two-arm randomized controlled trial. We recruited 108 participants aged 18-75 years who were discharged from the hospital after COVID-19 pneumonia that required >6 liters/minute of supplemental oxygen during treatment. Participants were randomly assigned at a 1:1 ratio to receive the combined rehabilitation program or usual posthospital care provided by a public Peruvian hospital. The intervention consisted of 12 at-home respiratory rehabilitation sessions and 6 telephone-based psychological sessions. The primary outcome was the 6-minute walk distance. Secondary outcomes included lung function, mental health status (depression, anxiety, and trauma), and quality of life. Outcomes were assessed at baseline (before randomization) and at 7 and 12 weeks after hospital discharge to assess the difference between arms.
RESULTS
This study was funded by the Peruvian National Council of Science Technology and Technology Innovation in July 2020. Ethics approval was obtained on September 2, 2020. Recruitment and data collection occurred between October 2020 and June 2021. Results are expected to be published by the end of 2022.
CONCLUSIONS
WAYRA was the first randomized controlled trial evaluating combined pulmonary-mental health rehabilitation for hospitalized COVID-19 survivors in resource-limited settings, potentially providing a foundation for the cost-effective scale-up of similar multidisciplinary rehabilitation programs.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04649736; https://clinicaltrials.gov/ct2/show/NCT04649736.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR1-10.2196/36001.
Identifiants
pubmed: 36108135
pii: v11i10e36001
doi: 10.2196/36001
pmc: PMC9595592
doi:
Banques de données
ClinicalTrials.gov
['NCT04649736']
Types de publication
Journal Article
Langues
eng
Pagination
e36001Subventions
Organisme : FIC NIH HHS
ID : D43 TW007393
Pays : United States
Investigateurs
Carolyn Reuland
(C)
Alan Quispe-Sancho
(A)
Informations de copyright
©Anderson N Soriano-Moreno, Elaine C Flores, Stella M Hartinger, Claudia Y Mallma, Arnold A Diaz, Gonzalo E Gianella, Juan A Galvez-Buccollini, Abdiel H Coico-Lama, German Malaga, Eufemia Fajardo, Rubí Paredes-Angeles, Sharlyn Otazú-Alfaro, Andres G Lescano, William Checkley, WAYRA Trial Investigators. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 24.10.2022.
Références
J Biomed Inform. 2009 Apr;42(2):377-81
pubmed: 18929686
BMJ Open. 2019 Mar 30;9(3):e026246
pubmed: 30928949
Int J Chron Obstruct Pulmon Dis. 2022 Jan 13;17:141-153
pubmed: 35046649
Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7
pubmed: 12091180
Int J Environ Res Public Health. 2022 Apr 24;19(9):
pubmed: 35564579
Health Qual Life Outcomes. 2010 Jan 20;8:8
pubmed: 20089179
J Clin Epidemiol. 2013 Feb;66(2):197-201
pubmed: 23195919
PLoS One. 2020 Dec 28;15(12):e0244171
pubmed: 33370364
Chronic Dis Transl Med. 2020 May 14;6(2):79-86
pubmed: 32411496
Health Qual Life Outcomes. 2014 Dec 05;12:181
pubmed: 25479769
Complement Ther Clin Pract. 2020 May;39:101166
pubmed: 32379637
Braz J Phys Ther. 2017 May - Jun;21(3):167-174
pubmed: 28473280
COPD. 2005 Mar;2(1):75-9
pubmed: 17136966
JAMA Netw Open. 2021 May 3;4(5):e2111417
pubmed: 34037731
BMJ Glob Health. 2021 Sep;6(9):
pubmed: 34580069
Trials. 2021 Jan 06;22(1):8
pubmed: 33407804
J Infect Dis. 2022 Apr 16;:
pubmed: 35429399
BMC Psychiatry. 2021 Feb 18;21(1):111
pubmed: 33602157
Gac Sanit. 2005 Mar-Apr;19(2):135-50
pubmed: 15860162
Med Clin (Barc). 1995 May 27;104(20):771-6
pubmed: 7783470
PM R. 2022 Jan;14(1):96-111
pubmed: 34902226
Respir Care. 2010 Jul;55(7):873-7
pubmed: 20587099
Nature. 2022 Aug;608(7923):603-608
pubmed: 35790190
PM R. 2022 Jan;14(1):77-95
pubmed: 34902224
PLoS One. 2019 Sep 9;14(9):e0221717
pubmed: 31498796
Ann Med Surg (Lond). 2022 Aug;80:103995
pubmed: 35721785
Transplant Proc. 2011 May;43(4):1322-4
pubmed: 21620120
Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88
pubmed: 31613151
Depress Anxiety. 2009;26(8):E91-8
pubmed: 19180584
Sci Rep. 2021 Aug 9;11(1):16144
pubmed: 34373540
Eur Psychiatry. 2018 Feb;48:27-37
pubmed: 29331596
Phys Ther. 2021 Nov 1;101(11):
pubmed: 34160029