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

Sponsor
Franciscus Gasthuis (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06123052
Collaborator
Jeroen Bosch Ziekenhuis (Other)
24
5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Interview

Study Design

Study Type:
Observational
Anticipated Enrollment :
24 participants
Observational Model:
Other
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Patients unwilling to receive information

Interview

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.

Patients not interested in IBD-CE after receiving information

Interview

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.

Patients interested in IBD-CE after receiving information

Interview

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.

Outcome Measures

Primary Outcome Measures

  1. Explorative data [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Franciscus Gasthuis
  • Jeroen Bosch Ziekenhuis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Franciscus Gasthuis
ClinicalTrials.gov Identifier:
NCT06123052
Other Study ID Numbers:
  • 2023.07.06.01
First Posted:
Nov 8, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Franciscus Gasthuis
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023