A Qualitative Study on Patients' (un)Ability and (un)Willingness to Use Telemonitoring in Inflammatory Bowel Diseases

Inflammatory Bowel Diseases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06123052
• Other study ID #: 2023.07.06.01
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Franciscus Gasthuis
• Contact: Stijn Lathouwers, BSc
• Phone: +31646896752
• Email: stijn.lathouwers[@]ru.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Equity
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Telemedicine

Intervention

Other:
• Interview
This is a descriptive qualitative study using semi-structured individual interviews. The interview will aim to collect more information about the patients' underlying motives that influence their ability or willingness to use IBD-CE. An interview guide has been developed for this purpose, based on topics derived from the Unified Theory of Acceptance and Use of Technology (UTAUT) model, the COM-B model for behavioural change and the model of positive health. This interview guide is divided into four sections, each introduced by an initial question. Subsequent follow-up questions will be formulated based on the patients' responses. Furthermore, patient characteristics, disease characteristics, and socio-demographic data will be collected from the Electronic Medical Record (EMR). These data will provide insights into various aspects of the patients' profiles and are based on characteristics that seem to be determinants of technology acceptance and/or digital health literacy.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Franciscus Gasthuis	Jeroen Bosch Ziekenhuis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Explorative data	Based on topics derived from the Unified Theory of Acceptance and Use of Technology (UTAUT) model, the COM-B model for behavioral change, and the model of positive health. This data is evaluated with the semi-structured interview	through study completion, an average of 6 months