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Health-Related Quality of Life for Thyroid Patients
This study has been completed.
Sponsors and Collaborators: Odense University Hospital
Rigshospitalet, Denmark
University of Copenhagen
Information provided by: Odense University Hospital
ClinicalTrials.gov Identifier: NCT00150033
  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 a well-tested, disease specific quality of life questionnaire is especially needed. Several treatment possibilities exist for each thyroid disease. For example, hypermetabolism can be treated with either medication, radioactive iodine or by surgery. No comparative studies of quality of life using the different treatment modalities exist.

Purpose:

To develop and evaluate a questionnaire to measure health-related quality of life 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 quality of life and, in the long-term, whether a difference in quality of life 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 Diseases
Phase II

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Development and Validation of a Thyroid-Specific Quality of Life Measure

Further study details as provided by Odense University Hospital:

Estimated Enrollment: 1200
Study Start Date: May 2005
Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with benign thyroid disease.

Exclusion Criteria:

  • Unable to complete questionnaire: must be able to read and write Danish
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150033

Locations
Denmark, Sealand
Department of Endocrinology, Rigshospitalet
Copenhagen, Sealand, Denmark, 2100
Sponsors and Collaborators
Odense University Hospital
Rigshospitalet, Denmark
University of Copenhagen
Investigators
Principal Investigator: Torquil Watt, MD Rigshospitalet, Denmark
Study Director: Ulla Feldt-Rasmussen, MD, DMSc Copenhagen Trial Unit, Center for Clinical Intervention Research
  More Information

Publications of Results:
Other Publications:
Responsible Party: Copenhagen University Hospital Rigshospitalet ( Torquil Watt, MD )
Study ID Numbers: 011
Study First Received: September 6, 2005
Last Updated: May 21, 2008
ClinicalTrials.gov Identifier: NCT00150033  
Health Authority: Denmark: National Board of Health

Keywords provided by Odense University Hospital:
thyroid disease
Quality of Life
Patient reported outcome
questionnaire
Quality of Life measurement

Study placed in the following topic categories:
Quality of Life
Endocrine System Diseases
Endocrinopathy
Thyroid Diseases

ClinicalTrials.gov processed this record on January 16, 2009