NCT07155486

Brief 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. 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: 1\. 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:

  1. 1.The Three-Talk Model
  2. 2.AAMC Telehealth Competencies Data will be analysed using thematic analysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

August 20, 2025

Last Update Submit

August 27, 2025

Conditions

Keywords

Inflammatory Bowel DiseaseShared Decision Making

Outcome Measures

Primary Outcomes (1)

  • 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

    Through study completion, an average of 2 months

Study Arms (2)

Healthcare providers

Interviews with healthcare providers

Other: Interview

Patients

Interviews with patiens

Other: Interview

Interventions

Interview

Healthcare providersPatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Age \> 18 years
  • Confirmed IBD diagnosis

You may not qualify if:

  • Non

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5223GZ, Netherlands

Location

Franciscus

Rotterdam, 3045PM, Netherlands

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Tessa EH Römkens, MD PhD

    Jeroen Bosch Ziekenhuis

    PRINCIPAL INVESTIGATOR
  • Rachel L West, MD PhD

    Franciscus Gasthuis

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 20, 2025

First Posted

September 4, 2025

Study Start

April 7, 2025

Primary Completion

June 6, 2025

Study Completion

July 1, 2025

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations