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

NCT06123052 | Completed

• 1 other identifier: 2023.07.06.01
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

Crohn's disease and ulcerative colitis (inflammatory bowel disease, IBD) are chronic intestinal inflammations with considerable impact on quality of life. Due to the chronic nature of the disease and the complex treatment involving regular outpatient follow-up visits, IBD care places a substantial burden on both patients and the healthcare system. Providing appropriate care, as described in the National Integrated Care Agreement, is becoming increasingly important. Telemonitoring is a promising alternative to conventional consultations, with evidence even suggesting improved quality of care. We have developed the telemonitoring application \*IBD Thuis\* to measure disease activity at home. The aim of this study is to develop a more effective, safe, and patient-centered approach to telemonitoring, and to deliver the right care in the right place in line with the National Integrated Care Agreement. In this study, we investigate which patients are suitable for telemonitoring. Through interviews, we aim to gain insight into the factors that influence patients' willingness and ability to use telemonitoring, with specific attention to behavior change and technology acceptance.

Conditions

Telemedicine; Inflammatory Bowel Diseases; Disparity; Health Equity

Keywords

UTAUT2; COM-B; Patient empowerment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients not interested in IBD-CE

Interview

Other: Interview

Patients interested in IBD-CE

Interview

Other: Interview

Interventions

Interview OTHER

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.

Patients interested in IBD-CE; Patients not interested in IBD-CE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Franciscus Gasthuis: lead
• Jeroen Bosch Ziekenhuis: collaborator

Study Sites (2)

Jeroen Bosch Ziekehuis

's-Hertogenbosch, 5223GZ, Netherlands

Location

Franciscus

Rotterdam, 3045PM, Netherlands

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Patient Participation

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: November 8, 2023
• Study Start: February 2, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)