Health-Related Quality of Life for Thyroid Patients

This study has been completed.
Sponsor:
Collaborators:
Rigshospitalet, Denmark
University of Copenhagen
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00150033
First received: September 6, 2005
Last updated: May 21, 2008
Last verified: May 2008
  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 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Development and Validation of a Thyroid-Specific Quality of Life Measure

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150033

Locations
Denmark
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 University Hospital
  More Information

Publications:
Responsible Party: Torquil Watt, MD, Copenhagen University Hospital Rigshospitalet
ClinicalTrials.gov Identifier: NCT00150033     History of Changes
Other Study ID Numbers: 011
Study First Received: September 6, 2005
Last Updated: May 21, 2008
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

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014