TelemedicineNCT06123052
A Qualitative Study on Patients' (un)Ability and (un)Willingness to Use Telemonitoring in Inflammatory Bowel Diseases
An observational study of Telemedicine and Inflammatory Bowel Diseases, run by Franciscus Gasthuis at 2 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telemedicine, Inflammatory Bowel Diseases, Disparity
- What is being tested?
- Interview
- How many people
- 18 participants
- Where
- 2 sitesNetherlands
- Study dates
- 2 Feb 2024to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Presence of a stoma
- Presence of an ileo-anal pouch or ileorectal anastomosis
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Jeroen Bosch Ziekehuis
's-Hertogenbosch, 5223GZ
Franciscus
Rotterdam, 3045PM
About this study
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
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.
Read the detailed description
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:
- 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 we 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:
- The Unified Theory of Acceptance and Use of Technology (UTAUT) model
- The COM-B model for behavioural change
- 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 they 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: Our objective is to get better insights in the motivations of patients to choose for telemonitoring or standard care. We aim to comprehend the requirements of patients to provide them with care that aligns with patients' needs.
- Conditions
- Telemedicine, Inflammatory Bowel Diseases, Disparity, Health Equity
- Being tested
- Interview
- Keywords
- UTAUT2, COM-B, Patient empowerment
- Medical subject headings
- Inflammatory Bowel Diseases, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients not interested in IBD-CE | Interview Receives: Other: Interview | |
| Patients interested in IBD-CE | Interview Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start2 Feb 2024
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franciscus Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- Jeroen Bosch Ziekenhuis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123052
- Sponsor's protocol ID
- 2023.07.06.01
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2023
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06123052
- Acronym / sponsor ID
- 2023.07.06.01
- Conditions
- Telemedicine, Inflammatory Bowel Diseases, Disparity, Health Equity
- Keywords
- UTAUT2, COM-B, Patient empowerment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Franciscus GasthuisUniversity, hospital or other
- Collaborators
- Jeroen Bosch Ziekenhuis
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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 we 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:
- The Unified Theory of Acceptance and Use of Technology (UTAUT) model
- The COM-B model for behavioural change
- 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 they 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: Our objective is to get better insights in the motivations of patients to choose for telemonitoring or standard care. We aim to comprehend the requirements of patients to provide them with care that aligns with patients' needs.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients not interested in IBD-CE | – | Other: InterviewInterview |
| Patients interested in IBD-CE | – | Other: InterviewInterview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Presence of a stoma
- Presence of an ileo-anal pouch or ileorectal anastomosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewThis 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. | Other | Patients interested in IBD-CE, Patients not interested in IBD-CE |
Primary outcome
Explorative data
Time frame: through study completion, an average of 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Telemedicine and Inflammatory Bowel Diseases, run by Franciscus Gasthuis at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explorative data (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.