Clinical trial NCT04388579: Screening Patients for a Strategic Shift to Pulmonary Telerehabilitation Because of COVID-19
Official title: PRAISE@COVID-19: Screening Patients for a Strategic Shift to Pulmonary Telerehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Disease
Keywords: self-efficacy
PRAISE
Pulmonary Telerehabilitation
Lead sponsor: University of Lisbon
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar Lisboa Norte
name: Fundação para a Ciência e a Tecnologia
name: Nippon Gases Portugal, Unipessoal, Lda.
First posted: 2020-05-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient's self-efficacy
timeFrame: 3 days
Secondary outcomes:
measure: Respiratory exercises
timeFrame: 3 days
measure: Physical activity
timeFrame: 3 days
Other outcomes:
measure: Treatment sessions completed
timeFrame: 3 days
measure: Treatment weekly frequency
timeFrame: 3 days
Locations:
city: Maia
country: Portugal
facility: Nippon Gases Portugal Unipessoal Lda
state: Porto
city: Lisboa
country: Portugal
facility: Universidade de Lisboa, Faculdade de Medicina, Instituto de Saúde Ambiental (ISAMB)
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário Lisboa Norte, Hospital Pulido Valente, Unidade de Reabilitação Respiratória
Study officials:
affiliation: University of Lisbon
name: Catarina D Santos, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Lisbon
name: Cristina Bárbara, PhD
role: STUDY_DIRECTOR
References: