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

Sponsor
University of Lisbon (Other)
Overall Status
Completed
CT.gov ID
NCT04388579
Collaborator
Centro Hospitalar Lisboa Norte (Other), Fundação para a Ciência e a Tecnologia (Other), Nippon Gases Portugal, Unipessoal, Lda. (Other)
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pulmonary Rehabilitation

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
PRAISE@COVID-19: Screening Patients for a Strategic Shift to Pulmonary Telerehabilitation
Actual Study Start Date :
Mar 20, 2020
Actual Primary Completion Date :
Mar 27, 2020
Actual Study Completion Date :
Mar 27, 2020

Outcome Measures

Primary Outcome Measures

  1. Patient's self-efficacy [3 days]

    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).

Secondary Outcome Measures

  1. Respiratory exercises [3 days]

    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.

  2. Physical activity [3 days]

    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.

Other Outcome Measures

  1. Treatment sessions completed [3 days]

    Number of Pulmonary Rehabilitation hospital sessions completed as outpatient, according to Hospital Pulido Valente information system

  2. Treatment weekly frequency [3 days]

    Number of Pulmonary Rehabilitation sessions planned per week, according to Hospital Pulido Valente information system

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 88 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nippon Gases Portugal Unipessoal Lda Maia Porto Portugal 4470- 177
2 Universidade de Lisboa, Faculdade de Medicina, Instituto de Saúde Ambiental (ISAMB) Lisboa Portugal 1649-028
3 Centro Hospitalar Universitário Lisboa Norte, Hospital Pulido Valente, Unidade de Reabilitação Respiratória Lisboa Portugal 1649-035

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Catarina D Santos, MSc, University of Lisbon
  • Study Director: Cristina Bárbara, PhD, University of Lisbon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Catarina Santos, PhD student, Physiotherapist MSc, University of Lisbon
ClinicalTrials.gov Identifier:
NCT04388579
Other Study ID Numbers:
  • 046i/17
First Posted:
May 14, 2020
Last Update Posted:
May 14, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Catarina Santos, PhD student, Physiotherapist MSc, University of Lisbon
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 14, 2020