NCT03875599

Brief Summary

This study aimed to translate and adapt to portuguese an original british instrument useful to measure respiratory patients' self-efficacy specific to the context of Pulmonary Rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

4 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

January 19, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

10 months

First QC Date

March 11, 2019

Last Update Submit

March 19, 2019

Conditions

Keywords

self-efficacyinstrument validityPRAISE

Outcome Measures

Primary Outcomes (1)

  • Patients' 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. Araújo and Moura (2011) already validated a Portuguese version of the GSE, yet the assessment of self-efficacy remains to be explored on the Portuguese Pulmonary Rehabilitation setting. This study translated, culturally adapted and evaluated reliability and validity of PRAISE on Portuguese respiratory patients, with original author's permission. Hence, items 4, 7, 9, 12 and 15 were specific to Pulmonary Rehabilitation as proposed by PRAISE original authors, and the remaining items and answer key were in accordance with the portuguese GSE.

    2 weeks

Interventions

Respiratory Physiotherapy, Exercise Therapy, Patient Education

Eligibility Criteria

Age26 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

150 adults attending an outpatient Pulmonary Rehabilitation program based at Hospital Pulido Valente from Centro Hospitalar Universitário de 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 (4)

Instituto Nacional de Saúde Doutor Ricardo Jorge, Departamento de Epidemiologia

Lisbon, 1600-560, 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

Instituto Politécnico de Lisboa, Escola Superior de Tecnologia da Saúde de Lisboa, Unidade de Ensino e Investigação em Psicologia e Sociologia

Lisbon, 1990-094, Portugal

Location

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

March 11, 2019

First Posted

March 15, 2019

Study Start

January 19, 2018

Primary Completion

November 23, 2018

Study Completion

November 23, 2018

Last Updated

March 21, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations