IBD (Inflammatory Bowel Disease)NCT07155486
IBD-SDM Telemonitoring Interview
An observational study of IBD (Inflammatory Bowel Disease) and Shared Decision Making, run by Franciscus Gasthuis at 2 sites in Netherlands.
Trial summary
Introduction: Telemedicine has shown to play a promising role in enhancing patient care. Moreover, it is a key component of the Integraal Zorgakkoord (IZA), facilitating more efficient and accessible healthcare through telemonitoring and digital health innovations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- IBD (Inflammatory Bowel Disease), Shared Decision Making, Telemedicine
- What is being tested?
- Interview
- How many people
- 17 participants
- Where
- 2 sitesNetherlands
- Study dates
- 7 Apr 2025to 1 Jul 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population comprises adult (≥18 years) IBD patients and IBD healthcare professionals at JBZ and Franciscus who have experienced making a choice about telemonitoring. These hospitals are teaching institutions with a combined patient population of approximately 4000 individuals.
Who may be able to join
- Age > 18 years
- Confirmed IBD diagnosis
Who cannot join
- Non
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223GZ
Franciscus
Rotterdam, 3045PM
About this study
Official title: A Qualitative Study on Shared Decision Making in the Choice to Use Telemonitoring in the Management of Inflammatory Bowel Disease
Introduction: Telemedicine has shown to play a promising role in enhancing patient care. Moreover, it is a key component of the Integraal Zorgakkoord (IZA), facilitating more efficient and accessible healthcare through telemonitoring and digital health innovations. However, it remains uncertain how Shared Decision Making (SDM) plays a role in the choice of telemedicine. Research focuses on technological capabilities or general patient-centredness, rather than how to effectively integrate SDM into decisions about using telemonitoring versus standard care. The integration of SDM into telemonitoring remains fragmented, suggesting that current SDM frameworks have not been adapted to the shift to telemedicine. If SDM is not achieved in this decision a decrease of adherence and engagement may follow.
Research question: The aim of this qualitative study is to get a better understanding of role of SDM in the choice of telemonitoring or standard care. These insights could help to offer improvements to SDM in IBD care to patients. This led to the following research questions:
Read more
- How to optimize the decision-making process for patients with inflammatory bowel disease in the decision for telemonitoring? 1.1 How do patients and healthcare professionals perceive the current SDM within care processes for IBD?
Study design: This is a qualitative study using semi-structured interviews. Information about patient's and professionals' experiences and preferences about SDM will be collected. To guide the topics in the interview, two theories/models will be used:
- The Three-Talk Model
- AAMC Telehealth Competencies Data will be analysed using thematic analysis.
Study population: Consecutive adult (≥18 years) IBD patients and IBD healthcare professionals at Jeroen Bosch Hospital and Franciscus who have experienced making a choice about telemonitoring will be asked if they are willing to participate. Next, a total of 16 respondents will be include 10 patients and 6 healthcare professionals. Both patients using telemonitoring and patients who are not interested will be included. Should data saturation not have occurred, more respondents will be included.
Expected results and relevance: The objective is to investigates if and how SDM is currently integrated into the telemonitoring processes for IBD patients. The goal is to use these insights to strengthen SDM in the decision for telemonitoring for IBD patients.
- Being tested
- Interview
- Keywords
- Inflammatory Bowel Disease, Shared Decision Making
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Interview
| Study group | Role | What they receive |
|---|---|---|
| Healthcare providers | Interviews with healthcare providers Receives: Other: Interview | |
| Patients | Interviews with patiens 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 three talk model and the AAMC Telehealth competencies. This data is evaluated with the semi-structured interviews
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start7 Apr 2025
- Primary completion6 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD (Inflammatory Bowel Disease)Studies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franciscus Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- Jeroen Bosch Ziekenhuis
- Responsible party
- Sponsor
- Investigators
- Tessa EH Römkens, MD PhD, Principal investigator, Jeroen Bosch ZiekenhuisRachel L West, MD PhD, Principal investigator, Franciscus Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155486
- Sponsor's protocol ID
- 2025.03.09.01
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 4 Sep 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 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Study on Shared Decision Making in the Choice to Use Telemonitoring in the Management of Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07155486
- Acronym / sponsor ID
- 2025.03.09.01
- Keywords
- Inflammatory Bowel Disease, Shared Decision Making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Franciscus GasthuisUniversity, hospital or other
- Collaborators
- Jeroen Bosch Ziekenhuis
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 4 Sep 2025 (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.
Introduction: Telemedicine has shown to play a promising role in enhancing patient care. Moreover, it is a key component of the Integraal Zorgakkoord (IZA), facilitating more efficient and accessible healthcare through telemonitoring and digital health innovations. However, it remains uncertain how Shared Decision Making (SDM) plays a role in the choice of telemedicine. Research focuses on technological capabilities or general patient-centredness, rather than how to effectively integrate SDM into decisions about using telemonitoring versus standard care. The integration of SDM into telemonitoring remains fragmented, suggesting that current SDM frameworks have not been adapted to the shift to telemedicine. If SDM is not achieved in this decision a decrease of adherence and engagement may follow.
Research question: The aim of this qualitative study is to get a better understanding of role of SDM in the choice of telemonitoring or standard care. These insights could help to offer improvements to SDM in IBD care to patients. This led to the following research questions:
- How to optimize the decision-making process for patients with inflammatory bowel disease in the decision for telemonitoring? 1.1 How do patients and healthcare professionals perceive the current SDM within care processes for IBD?
Study design: This is a qualitative study using semi-structured interviews. Information about patient's and professionals' experiences and preferences about SDM will be collected. To guide the topics in the interview, two theories/models will be used:
- The Three-Talk Model
- AAMC Telehealth Competencies Data will be analysed using thematic analysis.
Study population: Consecutive adult (≥18 years) IBD patients and IBD healthcare professionals at Jeroen Bosch Hospital and Franciscus who have experienced making a choice about telemonitoring will be asked if they are willing to participate. Next, a total of 16 respondents will be include 10 patients and 6 healthcare professionals. Both patients using telemonitoring and patients who are not interested will be included. Should data saturation not have occurred, more respondents will be included.
Expected results and relevance: The objective is to investigates if and how SDM is currently integrated into the telemonitoring processes for IBD patients. The goal is to use these insights to strengthen SDM in the decision for telemonitoring for IBD patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare providers | – | Other: InterviewInterviews with healthcare providers |
| Patients | – | Other: InterviewInterviews with patiens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises adult (≥18 years) IBD patients and IBD healthcare professionals at JBZ and Franciscus who have experienced making a choice about telemonitoring. These hospitals are teaching institutions with a combined patient population of approximately 4000 individuals.
Key inclusion criteria (2 listed)
- Age > 18 years
- Confirmed IBD diagnosis
Key exclusion criteria (1 listed)
- Non
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 |
|---|---|---|
| InterviewInterview | Other | Healthcare providers, Patients |
Primary outcome
Explorative Data
Time frame: Through study completion, an average of 2 months
Based on topics derived from the three talk model and the AAMC Telehealth competencies. This data is evaluated with the semi-structured interviews
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 4 Sep 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.
Tessa EH Römkens, MD PhD principal investigator
Jeroen Bosch Ziekenhuis
Rachel L West, MD PhD principal investigator
Franciscus Gasthuis
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 IBD (Inflammatory Bowel Disease) and Shared Decision Making, 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 2 inclusion and 1 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 4 Sep 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 2 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 4 Sep 2025.