Quality of Life, Health-Related |
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Clinical Trial: Health-Related Quality of Life of Thyroid Patients
This study is currently recruiting patients.
Verified by Odense University Hospital September 2005
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Purpose
Background
Thyroid diseases are frequent. They include both metabolic changes and gland enlargement (goitre). Previous research and clinical suspicion indicate that the life quality of many patients is reduced despite successful treatment. Research methods are, however, weak, and especially a well-tested, disease specific life quality questionnaire is needed. Several treatment possibilities exist for the each thyroid disease. For example, hypermetabolism can be treated with either medication, radioactive iodine or by surgery. No comparative studies of life quality using the different treatment modalities exist.
Purpose
To develop and evaluate a questionnaire to measure health-realted life quality in patients suffering from thyroid diseases.
Methods
To ensure that all relevant aspects are included, the questionnaire will be developed on the basis of a systematic examination of the scientific literature and interviews with 13 physicians and 100 patients. The questionnaire will then be tested by 100 new patients. After revision, the questionnaire will be answered by 1000 patients with a view to scientifically investigate the measuring capacity of the questionnaire. This will be done using traditional psychology methods (psychometry) as well as modern statistical methods (structural equations for categorical data and "item response" models).
Relevance
The above-mentioned questionnaire is necessary for clarifying whether these diseases reduce life quality and in the long-term whether a difference in life quality exists using the different treatment alternatives and whether treatment can be improved. It should also be included in quality protection studies, in the evaluation of new treatment modalities and possibly also in the treatment of the individual patient.
| Condition | Phase |
|---|---|
| Thyroid Disease | Phase II |
MedlinePlus related topics: Thyroid Diseases
Study Type: Observational
Study Design: Psychosocial, Cross-Sectional, Convenience Sample, Prospective Study
Official Title: Development and Validation of a Thyroid-Specific Quality of Life Measure.
Expected Total Enrollment: 1200
Study start: May 2005; Expected completion: January 2008
Eligibility
Inclusion Criteria:
All out-patient patients with benign thyroid disease.
Exclusion Criteria:
Unable to complete questionnaire: must be able to read and write Danish
Location and Contact Information
Denmark, Sealand
Department of Endocrinology, Rigshospitalet, Copenhagen, Sealand, 2100, Denmark; Recruiting
Laszlo Hegedüs, MD, DMSc +45 6541 1710 laszlo.hegedus@ouh.fyns-amt.dk
Torquil Watt, MD, Principal Investigator
Torquil Watt, MD, Principal Investigator, Rigshospitalet, Denmark
More Information
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150033
Health Authority: Denmark: National Board of Health
ClinicalTrials.gov processed this record on 2005-09-13

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