- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00251420
Writing About Disease: Effect on Rehabilitation?
Study Overview
Detailed Description
Chronic obstructive pulmonary disease (COPD) patients (age 35-70) and asthma patients (age 20-60) referred to a 4 weeks inpatient rehabilitation program - who agree to participate in the project - are randomly assigned to one of three conditions:
- Writing about emotional consequences of their disease before the program starts
- Writing about physical consequences of their disease before the program starts
- Not writing
All patients are measured (completing questionnaires at home) on: perceived quality of life, perceived health status and trait anxiety - 2 weeks before the program, 2 weeks after the program and 6 months after the program. FEV1 and 6 min walking distance are measured at the beginning and by the end of the program.
In addition to questionnaires, all patients are asked to:
- Write in their own words ( 2 weeks after) to evaluate their stay at the rehabilitation clinic; and
- Write in their own words (6 months after) about how the disease affects their life at that point.
Both quantitative and qualitative data will be used for analysis purposes.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Akershus
-
Hakadal, Akershus, Norway, 1485
- Glittreklinikken
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of COPD (age between 35 and 70)
- Clinical diagnosis of asthma (age between 20 and 60)
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life
Time Frame: prospective
|
prospective
|
Perceived health status
Time Frame: prospective
|
prospective
|
Trait anxiety
Time Frame: prospective
|
prospective
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Forced expiratory volume in 1 second (FEV1)
Time Frame: prospective
|
prospective
|
6-minute walking distance
Time Frame: prospective
|
prospective
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Einar Haave, Cand Psychol, LHL Helse
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- G22-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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