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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03875599
Other study ID # 46/17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 19, 2018
Est. completion date November 23, 2018

Study information

Verified date March 2019
Source University of Lisbon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Recent updates on Pulmonary Rehabilitation highlight the importance of patients' self-efficacy on long-term adherence to health-enhancing behaviors. The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) is an adaptation of the General Self-Efficacy Scale. This study aimed to translate, culturally adapt and evaluate reliability and validity of PRAISE on Portuguese respiratory patients.Forward-backward translation and pilot testing were performed. Content validity was assessed by a multidisciplinary panel of expert judges. To evaluate reliability and validity, 150 respiratory outpatients on Pulmonary Rehabilitation participated on a cross-sectional study. Descriptive and reliability analyses, and exploratory factorial analysis using principal axis factoring, followed by oblique oblimin factor rotation were conducted to identify construct validity. IBM® SPSS® version 22 was used to perform statistical analysis.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date November 23, 2018
Est. primary completion date November 23, 2018
Accepts healthy volunteers No
Gender All
Age group 26 Years to 89 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Pulmonary Rehabilitation
Respiratory Physiotherapy, Exercise Therapy, Patient Education

Locations

Country Name City State
Portugal Centro Hospitalar Universitário Lisboa Norte, Hospital Pulido Valente, Unidade de Reabilitação Respiratória Lisboa
Portugal Instituto Nacional de Saúde Doutor Ricardo Jorge, Departamento de Epidemiologia Lisboa
Portugal Instituto Politécnico de Lisboa, Escola Superior de Tecnologia da Saúde de Lisboa, Unidade de Ensino e Investigação em Psicologia e Sociologia Lisboa
Portugal Universidade de Lisboa, Faculdade de Medicina, Instituto de Saúde Ambiental (ISAMB) Lisboa

Sponsors (3)

Lead Sponsor Collaborator
University of Lisbon Centro Hospitalar Lisboa Norte, Fundação para a Ciência e a Tecnologia

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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