Celiac Disease in Childhood-Adulthood Transition

NCT05084937 | Enrolling By Invitation

• 1 other identifier: R20068
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

celiac disease; adolescents; transition; follow-up; gluten-free diet; quality of life; health; symptoms

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• General health and health concerns

  At the onset of the study

• Change in general health and health concerns

  After 1 and 3 years

• Symptoms

  At the onset of the study

• Change in symptoms

  After 1 and 3 years

• Quality of life

  At the onset of the study

Study Arms (2)

Structured transition

ACTIVE COMPARATOR

With the help of CeliCAT form

Other: CeliCAT form

Routine practices

NO INTERVENTION

Interventions

CeliCAT form OTHER

Systematic summary to support transition

Structured transition

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• verified celiac disease diagnosis in childhood (\<16 years of age)
• age 13-19 years at recruitment
• Finnish-speaking

You may not qualify if:

• disease or condition preventing the completing of the study questionnaire
• no celiac disease diagnosis
• age 13-19 years at recruitment
• Finnish-speaking

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University: collaborator
• Kuopio University Hospital: collaborator
• Turku University Hospital: collaborator
• Seinajoki Central Hospital: collaborator
• South Carelia Central Hospital: collaborator

Study Sites (5)

Kuopio University Hospital

Kuopio, Finland

Location

South Karelia Central Hospital

Lappeenranta, Finland

Location

Seinäjoki Central Hospital

Seinäjoki, Finland

Location

Tampere Celiac Disease Research Center, Tampere University

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Structured transition form is used with 50% of the study patients

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 20, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (5)