Screening Patients for a Strategic Shift to Pulmonary Telerehabilitation Because of COVID-19

Respiratory Disease Clinical Trial

— PRAISE@COVID  

Official title:

PRAISE@COVID-19: Screening Patients for a Strategic Shift to Pulmonary Telerehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04388579
• Other study ID #: 046i/17
• Status: Completed
• Start date: March 20, 2020
• Est. completion date: March 27, 2020

Study information

• Verified date: May 2020
• Source: University of Lisbon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study applied the Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) on respiratory patients who had their on-going ambulatory Pulmonary Rehabilitation program interrupted due to the COVID-19 outbreak. The research hypothesis is that ranking patients' self-efficacy is a useful screening tool to support patients' follow-up on a Pulmonary Rehabilitation telehealth solution to be explored during the COVID-19 outbreak.

Description:

This was an observational study applied to a convenience sample of Pulmonary Rehabilitation outpatients from Hospital Pulido Valente in Lisbon, Portugal, which had ambulatory treatments suspended due to the COVID-19 outbreak. Cross-sectional design was operationalized by a physiotherapist who promptly screened by phone a sample of 100 patients, assessing 90% of the eligible population. Patients had no previous therapeutic relation with the physiotherapist, who was also blind to patient's status at the Pulmonary Rehabilitation program. The screening call took a mean time of 484.8 ± 173.6 seconds, which is proximately about 8 ± 3 minutes per patient, with a minimum of 5 and a maximum of 19 minutes. Screening process included applying the Portuguese version of the Pulmonary Rehabilitation Adapted-Index of Self-Efficacy (PRAISE) and also included questioning patients if they were engaging on a daily routine of respiratory exercises by their initiative, and also if they managed to preserve a daily period to practice physical activity. In case of a positive answer, information concerning available equipment and exercise protocol adopted at patient's home environment was also collected. On a subsequent phase, data about patients' age, diagnosis referral for Pulmonary Rehabilitation, number of completed treatment sessions and weekly frequency, was collected from the hospital information system. Statistical analysis and data management were performed using the Statistical Package for the Social Sciences (SPSS) version 25.0 (SPSS Inc., Chicago, IL, USA). A formal sample size was not calculated since this was a convenience sample of 100 patients. Descriptive statistics included mean, standard-deviation, median, quartiles, range, minimum and maximum values and frequencies presented as percentages. Inferential statistics included the Pearson coefficient for PRAISE, age and number of treatment sessions, with the remaining variables analysed by the Spearman coefficient. PRAISE was the primary outcome, with mean comparison analysed by the Student t test, proved the normal distribution and equal variances. A p value of less than 0.05 was considered statistically significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 27, 2020
• Est. primary completion date: March 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

Inclusion Criteria:

• Patients with acute respiratory disease

• Patients with chronic respiratory disease

• Patients attending a hospital-based Pulmonary Rehabilitation program

Exclusion Criteria:

• Cognitive deficit for answering a questionnaire

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

Other:
• Pulmonary Rehabilitation
Respiratory Physiotherapy, Exercise Therapy, Patient Education

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Universitário Lisboa Norte, Hospital Pulido Valente, Unidade de Reabilitação Respiratória	Lisboa
Portugal	Universidade de Lisboa, Faculdade de Medicina, Instituto de Saúde Ambiental (ISAMB)	Lisboa
Portugal	Nippon Gases Portugal Unipessoal Lda	Maia	Porto

Sponsors (4)

Lead Sponsor	Collaborator
University of Lisbon	Centro Hospitalar Lisboa Norte, Fundação para a Ciência e a Tecnologia, Nippon Gases Portugal, Unipessoal, Lda.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment sessions completed	Number of Pulmonary Rehabilitation hospital sessions completed as outpatient, according to Hospital Pulido Valente information system	3 days
Other	Treatment weekly frequency	Number of Pulmonary Rehabilitation sessions planned per week, according to Hospital Pulido Valente information system	3 days
Primary	Patient's self-efficacy	Vincent and co-authors (2011) proposed the Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE). The PRAISE tool is composed by a total of 15 items, combining 10 items from the General Self-Efficacy Scale (GSE) by Schwarzer and Jerusalem (1995), and 5 new specific items related to Pulmonary Rehabilitation. Each item is scored from 1 to 4 with a total range from 15 to 60, with higher scores indicating higher levels of self-efficacy. This study applies the Portuguese PRAISE version by Santos CD and co-authors (2019).	3 days
Secondary	Respiratory exercises	Patients were questioned if they were engaging on a daily routine of respiratory exercises by their initiative while isolated at home COVID-19 outbreak. The answer was registered as yes/no.	3 days
Secondary	Physical activity	Patients were questioned if they managed to preserve a daily period to practice physical activity while isolated at home during COVID-19 outbreak. The answer was recorded as yes/no. In case of a positive answer, information concerning available equipment and exercise protocol adopted at patient's home environment was also collected.	3 days