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

NCT ID: NCT04388579

Last Updated: 2020-05-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-20
• Study Completion Date: 2020-03-27

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.

Conditions

Respiratory Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Pulmonary Rehabilitation

Respiratory Physiotherapy, Exercise Therapy, Patient Education

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Hospitalar Lisboa Norte

OTHER

Sponsor Role: collaborator

Fundação para a Ciência e a Tecnologia

OTHER

Sponsor Role: collaborator

Nippon Gases Portugal, Unipessoal, Lda.

UNKNOWN

Sponsor Role: collaborator

University of Lisbon

OTHER

Sponsor Role: lead

Responsible Party

Catarina Santos

PhD student, Physiotherapist MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catarina D Santos, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Lisbon

Cristina Bárbara, PhD

Role: STUDY_DIRECTOR

University of Lisbon

Locations

Nippon Gases Portugal Unipessoal Lda

Maia, Porto District, Portugal

Universidade de Lisboa, Faculdade de Medicina, Instituto de Saúde Ambiental (ISAMB)

Lisbon, , Portugal

Centro Hospitalar Universitário Lisboa Norte, Hospital Pulido Valente, Unidade de Reabilitação Respiratória

Lisbon, , Portugal

Countries

Portugal

Other Identifiers

046i/17

Identifier Type: -

Identifier Source: org_study_id