Clinical trial NCT06123052: A Qualitative Study on Patients' (un)Ability and (un)Willingness to Use Telemonitoring in Inflammatory Bowel Diseases
Official title: A Descriptive Qualitative Study Using Semi-structured Individual Interviews to Get a Better Understanding of Patients' (un)Ability and (un)Willingness to Use IBD Care Everywhere (IBD-CE), a Telemonitoring Application for Patients With Inflammatory Bowel Diseases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Telemedicine
Inflammatory Bowel Diseases
Disparity
Health Equity
Keywords: UTAUT2
COM-B
Patient empowerment
Lead sponsor: Franciscus Gasthuis
Sponsor class: OTHER
Collaborators: name: Jeroen Bosch Ziekenhuis
First posted: 2023-11-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will comprise adult (\>18 years) IBD patients visiting the outpatient clinics at Jeroen Bosch Hospital and Franciscus Gasthuis \& Vlietland. These hospitals are teaching institutions with a combined patient population of approximately 4000 individuals.

Brief summary: Introduction: Telemedicine has shown to play a promising role in improving IBD treatment. However, it remains uncertain which patients benefit from telemedicine. A feasibility and development project using IBD Care Everywhere (IBD-CE), a telemonitoring application, found that some patients were unable or unwilling to use the application. However, why patients were not able or willing to use the application remains unknown. The WHO global strategy aims to implement telemedicine while ensuring digital health equity. Concerns exist that telemedicine may exacerbate healthcare disparities.

Research question: The aim of this qualitative study is to get a better understanding of factors influencing patients' (un)ability and (un)willingness to use IBD-CE. These insights could help to offer the best individualised IBD care to patients. This led to the following research questions:

1. What influences patients' (un)ability or (un)willingness to use IBD Care Everywhere? 1.1 What are the distinguishing characteristics of patients (un)willing and (un)able to use IBD Care Everywhere? 1.2 How can care givers support patients in making an informed choice between telemonitoring and standard care?

Study design: This is a qualitative study using semi-structured interviews. Information about patient characteristics and potential factors that influence patients' ability or willingness to use IBD-CE will be collected. To guide the topics in the interview, three theories/models will be used:

1. The Unified Theory of Acceptance and Use of Technology (UTAUT) model
2. The COM-B model for behavioural change
3. The model of positive health Data will be analysed using thematic analysis.

Study population: Consecutive adult IBD patients (\> 18 years) in stable remission, visiting the outpatient clinic at the Jeroen Bosch Hospital and Franciscus Gasthuis \& Vlietland will be asked if the patients are willing to participate. Next, a total of 24 patients will be included through purposeful sampling. Both patients unwilling to use IBD-CE and patients interested in IBD-CE will be included. Should data saturation not have occurred, more patients will be included.

Expected results and relevance: The objective is to get better insights in the motivations of patients to choose for telemonitoring or standard care. This study aims to comprehend the requirements of patients to provide them with care that aligns with patients' needs.


Eligibility criteria: Inclusion Criteria:

* Aged \>18 years
* A confirmed IBD-diagnosis according to current guidelines
* Maintenance therapy with no medication changes in the last three months
* Remission:
* Crohn's disease: Faecal calprotectin (FCP) \< 100 µ g/g and Harvey Bradshaw Index (HBI) \< 5
* Ulcerative Colitis: Faecal calprotectin (FCP) \< 250 µ g/g and Simple Clinical Colitis Activity Index scores (SCCAI) \< 3

Exclusion Criteria:

* Presence of a stoma
* Presence of an ileo-anal pouch or ileorectal anastomosis

Primary outcomes:
measure: Explorative data
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
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Study officials:
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