Validation study of the Chronic Respiratory disease self-administered standardized Questionnaire and the feeling thermometer in Spanish language
| ISRCTN | ISRCTN03895886 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03895886 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/11/2005
- Registration date
- 19/04/2006
- Last edited
- 11/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Guell Rous M Rosa
Scientific
Scientific
C/Sant Antoni Maria Claret 167
Barcelona
08025
Spain
| Phone | +34 (0)93 556 57 10 |
|---|---|
| mguellr@santpau.es |
Study information
| Study design | Prospective, randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Scientific title | Validation study of the Chronic Respiratory disease self-administered standardized Questionnaire and the feeling thermometer in Spanish language |
| Study acronym | CRQ |
| Study objectives | The aim of this project is to study in-patients with chronic respiratory disease undergoing pulmonary rehabilitation: 1. The validity and responsiveness of two different administration modes of the feeling thermometer (FT) as a measure of health-related quality of life (HRQL) in Spanish language 2. The validity and responsiveness of the chronic respiratory disease (CRQ) self-administered, standardized version in Spanish language |
| Ethics approval(s) | Ethics approval not yet received as of 19/04/06 |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease (COPD) |
| Intervention | The methods centre will construct a central randomisation schedule. Patients will be stratified and randomised in blocks. Patients will be randomised to one of two conditions: 1. Self-administered FT, in the form of a visual analogue scale, preceded by ratings of three patient scenarios 2. Self-administered FT, in the form of a visual analogue scale, without prior ratings of three patient scenarios In a 2x2 factorial design, patients will also randomised to receive: 1. Self administered CRQ standardised version 2. Original version of CRQ (with interviewer) and dyspnoea domain on standardised version Both groups will receive the SF-36 Spanish version. |
| Intervention type | Other |
| Primary outcome measure | Validation of the Spanish version of CRQ |
| Secondary outcome measures | 1. Improved quality of life after a complete program of rehabilitation 2. Improve the results in CRQ after rehabilitation |
| Overall study start date | 01/10/2004 |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 patients |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Patients with chronic obstructive pulmonary disease (COPD) 2. At least three months of clinical stability since the admission in hospital 3. Age below 75 years 4. Forced expiratory volume (FEV1) or forced expiratory vital capacity (FVC) <70% and FEV1 <70% of the reference value, with any significant changes after the bronchodilator (<15% or 200 ml) 5. Dyspnoea measured by the Medical Research Council (MRC) >2 6. Distance on the six-minute walking test <300 m |
| Key exclusion criteria | 1. Having an osteomuscular pathology that limits exercise capacity 2. Having a cardiac disease that limits exercise capacity 3. Having a respiratory disease other than COPD that limits exercise capacity |
| Date of first enrolment | 01/10/2004 |
| Date of final enrolment | 01/10/2006 |
Locations
Countries of recruitment
- Spain
Study participating centre
C/Sant Antoni Maria Claret 167
Barcelona
08025
Spain
08025
Spain
Sponsor information
Hospital de la Santa Creu i Sant Pau (Spain)
Hospital/treatment centre
Hospital/treatment centre
Department of Pneumology
C/Sant Antoni Maria Claret 167
Barcelona
08025
Spain
"ROR" |
https://ror.org/059n1d175 |
|---|
Funders
Funder type
Hospital/treatment centre
Hospital de la Santa Creu i Sant Pau (Department of Pneumology)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2011 | 11/01/2021 | Yes | No |
Editorial Notes
11/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
