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
Protocol serial number	N/A
Sponsor	Hospital de la Santa Creu i Sant Pau (Spain)
Funder	Hospital de la Santa Creu i Sant Pau (Department of Pneumology)

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

C/Sant Antoni Maria Claret 167
Barcelona
08025
Spain

Phone	+34 (0)93 556 57 10
Email	mguellr@santpau.es

Study information

Primary study design	Interventional
Study design	Prospective, randomized controlled trial
Secondary study design	Randomised controlled trial
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(s)	Validation of the Spanish version of CRQ
Key secondary outcome measure(s)	1. Improved quality of life after a complete program of rehabilitation 2. Improve the results in CRQ after rehabilitation
Completion date	01/10/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.