ValIdation of Symptom and self-management InformatiON in Inflammatory Bowel Disease – A Real-World Observational Study Using a Patient-Centric Data Collection Approach

ValIdation of Symptom and self-management InformatiON in Inflammatory Bowel Disease – A Real-World Observational Study Using a Patient-Centric Data Collection Approach - VISION

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039666

Enrollment

282

Registered

2026-06-08

Start date

2026-06-22

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K50-K52

Interventions

Group 1: Patients with inflammatory bowel disease (IBD) use a digital self-management application ("CED Buddy") as part of routine care. Patient-reported outcomes (PROMIS, IBD Disk, PRO2, IBD-KNOW), a

Eligibility

Sex/Gender

All

Age

15 Years to No maximum

Inclusion criteria

Inclusion criteria: Confirmed diagnosis of inflammatory bowel disease (Crohn’s disease or ulcerative colitis) Possession of a compatible smartphone and willingness to use the app regularly Ability and willingness to provide written informed consent Ongoing care at one of the participating study sites

Exclusion criteria

Exclusion criteria: Severe cognitive, psychiatric, or physical impairment preventing meaningful participation or app use Participation in an interventional study that may interfere with study outcomes Acute severe disease flare at baseline (defined as need for intravenous corticosteroids or hospitalization within the past 30 days) Active severe infections (e.g., tuberculosis, sepsis, cytomegalovirus, listeriosis, or opportunistic infections such as progressive multifocal leukoencephalopathy)

Design outcomes

Primary

Measure	Time frame
Change in self-efficacy for managing symptoms and emotions in patients with inflammatory bowel disease, assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) Self-Efficacy scales for symptom and emotion management. Assessments are conducted at baseline and after 6 months.	—

Secondary

Measure	Time frame
1. Change in self-efficacy for managing symptoms, assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) Self-Efficacy scale for symptom management, at baseline and longitudinally up to month 12 with quarterly assessments. 2. Change in self-efficacy for managing emotions, assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) Self-Efficacy scale for emotion management, at baseline and longitudinally up to month 12 with quarterly assessments. 3. Change in health-related quality of life, assessed using PROMIS-29 (Patient-Reported Outcomes Measurement Information System Profile 29) and the IBD Disk (Inflammatory Bowel Disease Disk), at baseline and longitudinally up to month 12 with repeated assessments (daily to weekly, aggregated quarterly). 4. Change in disease-related knowledge, assessed using IBD-KNOW (Inflammatory Bowel Disease Knowledge Questionnaire), at baseline and quarterly up to month 12. 5. Change in health resource utilization (HRU), assessed using patient-reported data and clinical routine data (e.g., medication, outpatient visits, hospitalizations, emergency visits, procedures), at baseline and quarterly up to month 12. 6. Association between app usage and clinical outcomes, assessed using app-derived usage metrics (e.g., number of logins, frequency of PRO entries, dashboard use), continuously over the 12-month observation period.	—

Measure

Time frame

1. Change in self-efficacy for managing symptoms, assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) Self-Efficacy scale for symptom management, at baseline and longitudinally up to month 12 with quarterly assessments. 2. Change in self-efficacy for managing emotions, assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) Self-Efficacy scale for emotion management, at baseline and longitudinally up to month 12 with quarterly assessments. 3. Change in health-related quality of life, assessed using PROMIS-29 (Patient-Reported Outcomes Measurement Information System Profile 29) and the IBD Disk (Inflammatory Bowel Disease Disk), at baseline and longitudinally up to month 12 with repeated assessments (daily to weekly, aggregated quarterly). 4. Change in disease-related knowledge, assessed using IBD-KNOW (Inflammatory Bowel Disease Knowledge Questionnaire), at baseline and quarterly up to month 12. 5. Change in health resource utilization (HRU), assessed using patient-reported data and clinical routine data (e.g., medication, outpatient visits, hospitalizations, emergency visits, procedures), at baseline and quarterly up to month 12. 6. Association between app usage and clinical outcomes, assessed using app-derived usage metrics (e.g., number of logins, frequency of PRO entries, dashboard use), continuously over the 12-month observation period.

—

Countries

Austria, Germany

Contacts

Public ContactAlexander Obbarius

Charité - Universitätsmedizin Berlin

alexander.obbarius@charite.de+4930450656035

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026