Celiac Disease in Childhood-Adulthood Transition

Study Overview
=================
Brief Summary
-----------------
Aims of this study are to evaluate adolescents with celiac disease during their transition from pediatrics to adult care, and to develop better healthcare follow-up practices.

Detailed Description
-----------------
Celiac disease is one of the most common chronic gastrointestinal diseases affecting 1-3% of population worldwide. It is treated with life-long and strict gluten-free diet. When dietary treatment is successful, prognosis of pediatric patients seems to be excellent whereas ongoing predisposition to gluten may increase the risk even to permanent complications. However, gluten-free diet may cause burden and restrictions in everyday life impairing quality of life. Regular follow-up is recommended to support the treatment and to detect early possible comorbidities and complications, but, in practice, patients are often lost to follow-up. Studies about the significance of follow-up and its optimal implementation are scarce. Pediatric patients form a special group here as they may not even remember the reason for the diagnosis if it was set in early childhood, and the education about the disease and its treatment are often given primarily to the caregivers. Responsibility of the treatment shifts to patients themselves in adolescence at the same time with other significant changes in life and they have more often challenges with gluten-free diet than other patients. Despite this, studies about the transition from pediatrics to adult-care are very few. This study evaluates 13-19 years old patients diagnosed with celiac disease in childhood (<16 years of age) and compares them to adolescents without celiac disease in selected variables. Study focuses on healthcare follow-up practices and pilot a CeliCAT transition form in a randomized, controlled study design. The main hypothesis is that structured follow-up and transition of pediatric patients to adult care predicts better health, quality of life and adherence to the dietary treatment later in life. Data is collected with physical examination, questionnaires and with blood and urine samples. Follow-up is arranged at one and three years from the first visit.

Official Title
-----------------
Celiac Disease in Childhood-Adulthood Transition (CeliCAT)

Conditions
-----------------
Follow-up, Celiac Disease, Celiac Disease in Children, Transition of Care, Diet, Gluten-Free

Intervention / Treatment
-----------------
* Other: CeliCAT form


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: verified celiac disease diagnosis in childhood (<16 years of age) age 13-19 years at recruitment Finnish-speaking Exclusion Criteria: disease or condition preventing the completing of the study questionnaire Inclusion criteria for controls no celiac disease diagnosis age 13-19 years at recruitment Finnish-speaking

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Structured transition form is used with 50% of the study patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Structured transition<br>With the help of CeliCAT form | Other: CeliCAT form<br>* Systematic summary to support transition<br>|
| No Intervention: Routine practices<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to a gluten-free diet | Assessed with questionnaire, celiac autoantibodies and urine GIP | At the onset of the study | 
| Change in adherence to a gluten-free diet | Assessed with questionnaire, celiac autoantibodies and urine GIP | After 1 and 3 years | 
| Transition readiness | Assessed with questionnaire | At the onset of the study | 
| Change in transition readiness | Assessed with questionnaire | After 1 and 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General health and health concerns | Assessed with questionnaire | At the onset of the study | 
| Change in general health and health concerns | Assessed with questionnaire | After 1 and 3 years | 
| Symptoms | Assessed with questionnaire | At the onset of the study | 
| Change in symptoms | Assessed with questionnaire | After 1 and 3 years | 
| Quality of life | Assessed with questionnaire | At the onset of the study | 
| Change in quality of life | Assessed with questionnaire | After 1 and 3 years | 
| Costs | Assessed with questionnaire | At the onset of the study | 
| Abnormalities in follow-up laboratory evaluations | Assessed with blood sample | At the onset of the study | 
| Abnormalities in physical examination | Assessed with medical examination | At the onset of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
celiac disease, adolescents, transition, follow-up, gluten-free diet, quality of life, health, symptoms