Impact of the Diagnosis of Celiac Disease

Completed

• Conditions: Celiac Disease

• Registration Number: NCT01145287
• Lead Sponsor: Tampere University Hospital

Brief Summary

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.

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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-15
• Study First Posted: 2010-06-16
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 760

Inclusion Criteria

• diagnosis within one year
• biopsy-proven diagnosis

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psychological General Well-Being (PGWB) Index	5 years	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

Name	Time	Method
healthcare resource utilization	5 years	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)	5 years	clinical symptoms are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire
dietary compliance	5 years	self-assessed compliance to the dietary treatment
weight	5 years	effect of the dietary treatment in the weight of celiac disease patients
height	5 years	effect of the dietary treatment in the height of children with celiac disease
The Short Form (SF-36) Health Survey	5 years	Health-related quality of life and self-perceived health are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire

Trial Locations

Locations (1)

Pediatric Research Centre, University of Tampere, Tampere University Hospital; 🇫🇮 Tampere, Pirkanmaa, Finland