Condition category
Respiratory
Date applied
28/11/2005
Date assigned
19/04/2006
Last edited
19/04/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Hospital de la Santa Creu i Sant Pau (Spain)

Sponsor details

Department of Pneumology
C/Sant Antoni Maria Claret 167
Barcelona
08025
Spain

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes