Impact of the Diagnosis of Celiac Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Tampere University Hospital
Sponsor:
Collaborators:
University of Tampere
Finnish Celiac Society
Information provided by (Responsible Party):
Kalle Kurppa, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01145287
First received: June 7, 2010
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

The main purpose of this study is to assess the impact of the diagnosis of celiac disease on general health, healthcare resource utilization, quality of life and lifestyle. We hypothesize that diagnosis and subsequent dietary treatment may have positive impact on these variables.


Condition
Celiac Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of the Diagnosis of Celiac Disease

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • Psychological General Well-Being (PGWB) Index [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Health-related quality of life and self-perceived health are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire


Secondary Outcome Measures:
  • healthcare resource utilization [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Healthcare resuorce utilization measured as inpatient and outpatient visits and consumption of other medical services in addition to consumption of pharmaceutical agents

  • Gastrointestinal Symptoms Rating Scale (GSRS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    clinical symptoms are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire

  • dietary compliance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    self-assessed compliance to the dietary treatment

  • weight [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    effect of the dietary treatment in the weight of celiac disease patients

  • height [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    effect of the dietary treatment in the height of children with celiac disease

  • The Short Form (SF-36) Health Survey [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Health-related quality of life and self-perceived health are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire


Estimated Enrollment: 1100
Study Start Date: February 2007
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Detailed Description:

All new members with biopsy-proven celiac disease joining the Finnish Celiac Society will be categorized in three groups according to symptoms and signs leading to the diagnosis as classical symptoms, extraintestinal symptoms and screen-detected, the latest being further divided to those presenting with symptoms and those who are totally asymptomatic. Several parameters assessing general health and well-being, quality of life and healthcare resource utilization are evaluated at baseline and after one and five years on trial. Quality of life is compared to that of non-celiac controls.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All new members with biopsy-proven celiac disease joining the Finnish Celiac Society.

Criteria

Inclusion Criteria:

  • diagnosis within one year
  • biopsy-proven diagnosis

Exclusion Criteria:

  • Celiac disease diagnosis previously than within one year
  • No biopsy-proven diagnosis
  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: NCT01145287

Locations
Finland
Pediatric Research Centre, University of Tampere, Tampere University Hospital Recruiting
Tampere, Pirkanmaa, Finland, 33014
Contact: Kalle Kurppa, MD    +3583311611    kalle.kurppa@uta.fi   
Sponsors and Collaborators
Tampere University Hospital
University of Tampere
Finnish Celiac Society
  More Information

No publications provided by Tampere University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kalle Kurppa, M.D, pH.D, Pediatrician, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01145287     History of Changes
Other Study ID Numbers: Burden-1
Study First Received: June 7, 2010
Last Updated: February 18, 2014
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by Tampere University Hospital:
Celiac disease
Gluten-free diet
Screen-detected
Asymptomatic
Quality of life
Self-perceived health
Healthcare resource utilization

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on September 30, 2014