Functional digestive diseases, functional digestive disorders, functional gastrointestinal diseases, functional gastrointestinal disorders, disorders of gut-brain interaction, functional bowel disorders, irritable bowel syndrome, functional dyspepsia irritable bowel, irritable bowel syndrome, function digestive disorders
Conditions
Interventions
ZorgpadHulp is a 
software as a medical device. With ZorgpadHulp, the patient follows a 
digital care pathway lasting approximately 
8 weeks under the supervision of a gastroenterologist.ZorgpadHulp is a 
modular, digital tool (software as a medical device) that supports physicians in the 
diagnosis and treatment of disorders of gut-brain interaction. It is used 
after organic causes have been ruled out, in accordance with the 
Rome IV criteria.ZorgpadHulp promotes 
efficient diagnostics, 
accessible treatment, and contributes to 
self-management 
in patients with functional gastrointestinal disorders.
Sponsors
Quin B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Age = 18 years and = 65 yearsClinical suspicion of a disorder of gut-brain interaction (DGBI) following triage by a gastroenterologistSigned informed consent
Exclusion criteria
Exclusion criteria: Insufficient proficiency in the Dutch languageMedical history of severe gastrointestinal pathology (e.g., cancer or inflammatory bowel disease)Missing test results for coeliac disease (anti-tTG levels) or calprotectin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| I) The difference in consultation time required by the gastroenterologist per patient (diagnosis and treatment advice) in comparison to the benchmark.The time (in minutes) spent by the specialist per case within the digital care pathway will be measured. | — |
Secondary
| Measure | Time frame |
|---|---|
| II) Usability of the digital care pathway by the gastroenterologistA semi-structured interview will also be conducted after the study concludes (once full inclusion is reached) to perform a qualitative usability analysis.III) Effectiveness on self-perceived patient knowledge, skills, and confidence in self-management of functional complaints of the digital care pathway The effect of the digital care pathway on patients’ ability to self-manage functional symptoms will be measured at baseline, after first diagnosis/treatment advice and after completion of the digital care pathway, measured using the PAM-13 questionnaire. The midpoint scores will not be included in the statistical analysis but are collected for informative purposes on patients’ usability of the digital tool. Patient activation measure (PAM)The PAM is a validated tool that measures the extent to which patients have the knowledge, skills, and confidence to manage their own health and care. The Dutch PAM-13 (PAM-13 NL) consists of 13 items, each scored on a 4-point severity scale or marked as "not applicable," resulting in a numerical score.IV) Patient experience of received healthcare through the digital care pathwayThe experience of the patient of healthcare received through ZorgpadHulp will be measured by using Service User Technology Acceptability Questionnaire (SUTAQ) after completion of the digital care pathway. Service User Technology Acceptability Questionnaire (SUTAQ).The SUTAQ is an instrument that was developed to measure beliefs about the acceptability of telemedicine technology. The SUTAQ questionnaire consists of 22 items, scored on a 6-point Likert scale, reflecting varying degrees of agreement with each statement. Acceptability is defined as the sum of the instrument’s six domains (satisfaction, alternative toolkit, enhanced care, increased accessibility, privacy and discomfort, and thoughts on care personnel). | — |
Countries
Netherlands
Contacts
Public ContactN. Koopman
Quin B.V.
Outcome results
None listed