NCT04388579

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2020

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

7 days

First QC Date

May 12, 2020

Last Update Submit

May 12, 2020

Conditions

Keywords

self-efficacyPRAISEPulmonary Telerehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Respiratory exercises

    3 days

  • Physical activity

    3 days

Other Outcomes (2)

  • Treatment sessions completed

    3 days

  • Treatment weekly frequency

    3 days

Interventions

Respiratory Physiotherapy, Exercise Therapy, Patient Education

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patients with acute respiratory disease
  • Patients with chronic respiratory disease
  • Patients attending a hospital-based Pulmonary Rehabilitation program

You may not qualify if:

  • Cognitive deficit for answering a questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Nippon Gases Portugal Unipessoal Lda

Maia, Porto District, 4470- 177, Portugal

Location

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

Lisbon, 1649-028, Portugal

Location

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

Lisbon, 1649-035, Portugal

Location

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Catarina D Santos, MSc

    University of Lisbon

    PRINCIPAL INVESTIGATOR
  • Cristina Bárbara, PhD

    University of Lisbon

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student, Physiotherapist MSc

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 14, 2020

Study Start

March 20, 2020

Primary Completion

March 27, 2020

Study Completion

March 27, 2020

Last Updated

May 14, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations