- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04388579
Screening Patients for a Strategic Shift to Pulmonary Telerehabilitation Because of COVID-19 (PRAISE@COVID)
May 12, 2020 updated by: Catarina Santos, University of Lisbon
PRAISE@COVID-19: Screening Patients for a Strategic Shift to Pulmonary Telerehabilitation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lisboa, Portugal, 1649-028
- Universidade de Lisboa, Faculdade de Medicina, Instituto de Saúde Ambiental (ISAMB)
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Lisboa, Portugal, 1649-035
- Centro Hospitalar Universitário Lisboa Norte, Hospital Pulido Valente, Unidade de Reabilitação Respiratória
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Porto
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Maia, Porto, Portugal, 4470- 177
- Nippon Gases Portugal Unipessoal Lda
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
100 adults attending an outpatient Pulmonary Rehabilitation program based at Hospital Pulido Valente from Centro Hospitalar Universitário Lisboa Norte, in Lisbon, Portugal
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient's self-efficacy
Time Frame: 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).
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory exercises
Time Frame: 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.
|
3 days
|
Physical activity
Time Frame: 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.
|
3 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment sessions completed
Time Frame: 3 days
|
Number of Pulmonary Rehabilitation hospital sessions completed as outpatient, according to Hospital Pulido Valente information system
|
3 days
|
Treatment weekly frequency
Time Frame: 3 days
|
Number of Pulmonary Rehabilitation sessions planned per week, according to Hospital Pulido Valente information system
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Catarina D Santos, MSc, University of Lisbon
- Study Director: Cristina Bárbara, PhD, University of Lisbon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2020
Primary Completion (Actual)
March 27, 2020
Study Completion (Actual)
March 27, 2020
Study Registration Dates
First Submitted
May 12, 2020
First Submitted That Met QC Criteria
May 12, 2020
First Posted (Actual)
May 14, 2020
Study Record Updates
Last Update Posted (Actual)
May 14, 2020
Last Update Submitted That Met QC Criteria
May 12, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 046i/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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