- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03875599
Measuring Self-Efficacy on Portuguese Respiratory Patients on Pulmonary Rehabilitation (PRAISEPort)
March 19, 2019 updated by: Catarina Santos, University of Lisbon
Validation of the Pulmonary Rehabilitation Adapted Index of Self-Efficacy on Portuguese Respiratory Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lisboa, Portugal, 1649-028
- Universidade de Lisboa, Faculdade de Medicina, Instituto de Saúde Ambiental (ISAMB)
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Lisboa, Portugal, 1649-035
- Centro Hospitalar Universitário Lisboa Norte, Hospital Pulido Valente, Unidade de Reabilitação Respiratória
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Lisboa, Portugal, 1600-560
- Instituto Nacional de Saúde Doutor Ricardo Jorge, Departamento de Epidemiologia
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Lisboa, Portugal, 1990-094
- Instituto Politécnico de Lisboa, Escola Superior de Tecnologia da Saúde de Lisboa, Unidade de Ensino e Investigação em Psicologia e Sociologia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
26 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients' self-efficacy
Time Frame: 2 weeks
|
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.
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2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Catarina D Santos, MSc, University of Lisbon
- Study Director: Cristina Bárbara, PhD, University of Lisbon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 19, 2018
Primary Completion (Actual)
November 23, 2018
Study Completion (Actual)
November 23, 2018
Study Registration Dates
First Submitted
March 11, 2019
First Submitted That Met QC Criteria
March 13, 2019
First Posted (Actual)
March 15, 2019
Study Record Updates
Last Update Posted (Actual)
March 21, 2019
Last Update Submitted That Met QC Criteria
March 19, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 46/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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