Pulmonary RehabilitationPRAISEPortNCT03875599
Measuring Self-Efficacy on Portuguese Respiratory Patients on Pulmonary Rehabilitation
An observational study of Pulmonary Rehabilitation, run by University of Lisbon at 4 sites in Portugal.
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. Read more about this study
- Who is it for?
- Ages 26 to 89 years
- Conditions the study is for
- Pulmonary Rehabilitation
- What is being tested?
- Pulmonary Rehabilitation
- How many people
- 150 participants
- Where
- 4 sitesPortugal
- Study dates
- 19 Jan 2018to 23 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with acute respiratory disease
- Patients with chronic respiratory disease
- Patients attending a hospital-based Pulmonary Rehabilitation program
Who cannot join
- Cognitive deficit for answering a questionnaire
Trial locations and contacts
4 sites in 1 country.
Portugal4 sites
Instituto Nacional de Saúde Doutor Ricardo Jorge, Departamento de Epidemiologia
Lisbon, 1600-560
Universidade de Lisboa, Faculdade de Medicina, Instituto de Saúde Ambiental (ISAMB)
Lisbon, 1649-028
Centro Hospitalar Universitário Lisboa Norte, Hospital Pulido Valente, Unidade de Reabilitação Respiratória
Lisbon, 1649-035
Instituto Politécnico de Lisboa, Escola Superior de Tecnologia da Saúde de Lisboa, Unidade de Ensino e Investigação em Psicologia e Sociologia
Lisbon, 1990-094
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Rehabilitation
- Being tested
- Pulmonary Rehabilitation
- Keywords
- self-efficacy, instrument validity, PRAISE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
Respiratory Physiotherapy, Exercise Therapy, Patient Education
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start19 Jan 2018
- Primary completion23 Nov 2018
- Study completion23 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar Lisboa Norte, Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Catarina Santos, University of Lisbon
- Investigators
- Catarina D Santos, MSc, Principal investigator, University of LisbonCristina Bárbara, PhD, Study director, University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875599
- Sponsor's protocol ID
- 46/17
- Acronym
- PRAISEPort
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Pulmonary Rehabilitation Adapted Index of Self-Efficacy on Portuguese Respiratory Patients
- ClinicalTrials.gov ID
- NCT03875599
- Acronym / sponsor ID
- PRAISEPort / 46/17
- Conditions
- Pulmonary Rehabilitation
- Keywords
- self-efficacy, instrument validity, PRAISE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Collaborators
- Centro Hospitalar Lisboa Norte, Fundação para a Ciência e a Tecnologia
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 23 Nov 2018 (actual)
- Study completion
- 23 Nov 2018 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 26 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients with acute respiratory disease
- Patients with chronic respiratory disease
- Patients attending a hospital-based Pulmonary Rehabilitation program
Key exclusion criteria (1 listed)
- Cognitive deficit for answering a questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary RehabilitationRespiratory Physiotherapy, Exercise Therapy, Patient Education | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catarina D Santos, MSc principal investigator
University of Lisbon
Cristina Bárbara, PhD study director
University of Lisbon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Rehabilitation, run by University of Lisbon at 4 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' self-efficacy (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.