Contact information
Type
Scientific
Primary contact
Dr Guell Rous M Rosa
ORCID ID
Contact details
C/Sant Antoni Maria Claret 167
Barcelona
08025
Spain
+34 (0)93 556 57 10
mguellr@santpau.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
CRQ
Study hypothesis
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
Ethics approval not yet received as of 19/04/06
Study design
Prospective, randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/10/2004
Overall trial end date
01/10/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 patients
Participant 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
Recruitment start date
01/10/2004
Recruitment end date
01/10/2006
Locations
Countries of recruitment
Spain
Trial participating centre
C/Sant Antoni Maria Claret 167
Barcelona
08025
Spain
Funders
Funder type
Hospital/treatment centre
Funder name
Hospital de la Santa Creu i Sant Pau (Department of Pneumology)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary