- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07010055
- Original Trial
Using Digital Health in a Postoperative Setting After Major Surgery: Semi-structured Interview Study
June 6, 2025 updated by: Stessel Björn, Jessa Hospital
Using Digital Health in a Postoperative Setting After Major Surgery: a Prospective Single-center Qualitative Semi-structured Interview Study
This study aims to evaluate whether patients recognize a need for a remote monitoring care pathway during the post-operative period following major surgery at Jessa Hospital by means of a semi- structured interview.
Besides this, the study explores patient perceptions and willingness to participate in digital monitoring care pathways, identifies potential barriers to adoption, and addressing concerns related to safety, data security, and privacy.
Additionally, the study aims to assess patient needs regarding parameter collection, technology usage, and the overall functionality of digital monitoring systems, while evaluating the perceived usefulness of such a pathway in post-operative care.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Digital health technologies are transforming healthcare, offering new ways to improve patient outcomes and enhance efficiency.
Remote clinical monitoring (RCM), which uses digital technologies such as wearable devices and mobile apps to monitor patients outside of the traditional healthcare settings such as a hospital, holds significant potential for supporting post-operative care, especially in the context of faster hospital discharge after major surgery.
Major surgery involves procedures on organ systems, such as cancer resections, organ transplants, and lung or abdominal surgeries.
However, despite their promise, the successful implementation of these technologies into clinical practice requires a thorough understanding of the perspectives of the end user, being the patient.
Patients' comfort, engagement, and perceptions about digital health solutions, such as self-management tools and remote monitoring pathways, are essential to ensuring these technologies are both effective and widely accepted.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bjorn Stessel, MD, PhD
- Phone Number: +3211222107
- Email: bjorn.stessel@jessazh.be
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Surgical patients
- >18 years old, Undergone major surgery at Jessa Hospital Hasselt
Exclusion Criteria:
- Unable to provide informed consent or request to not participate in the study
- Cognitively incapable of understanding the study
- No understanding of the Dutch language
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Semi-structured interview
Conducting a semi-structured interview during a follow-up consultation after major surgery
|
A semi-structured interview will be conducted once in-person to each patient after a follow-up consultation in the hospital after their major surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Need for monitoring of vital and subjective parameters after discharge
Time Frame: During a follow-up consultation within one year after major surgery
|
The primary outcome measurement will be assessed by asking patients if they believe that there is a need for monitoring of vital and subjective parameters after discharge.
|
During a follow-up consultation within one year after major surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceptions regarding the implementation of digital monitoring care pathways
Time Frame: During a follow-up consultation within one year after major surgery
|
Patients' perceptions regarding the implementation of digital monitoring care pathways will be evaluated by asking questions about their experience and knowledge of remote care, their perceptions of whether digital monitoring can replace traditional face-to-face consultations, their need for digital information after discharge, and their experience with follow-up and contact with healthcare providers after discharge.
|
During a follow-up consultation within one year after major surgery
|
|
Willingness to participate in digital care pathways
Time Frame: During a follow-up consultation within one year after major surgery
|
To examine patients' willingness to participate in digital care pathways, following items are questioned: willingness to be discharged sooner with remote monitoring available, factors that would motivate patients to use or recommend remote monitoring, and comfort and willingness to have health monitored remotely through an app or device.
|
During a follow-up consultation within one year after major surgery
|
|
Potential barriers to adopt digital care
Time Frame: During a follow-up consultation within one year after major surgery
|
To identify potential barriers to adopt digital care, challenges in using remote care will be surveyed.
|
During a follow-up consultation within one year after major surgery
|
|
Concerns about safety
Time Frame: During a follow-up consultation within one year after major surgery
|
Patients' concerns about safety when being discharged earlier with remote monitoring in place are assessed to understand patient concerns about their own safety.
|
During a follow-up consultation within one year after major surgery
|
|
Accuracy of data
Time Frame: During a follow-up consultation within one year after major surgery
|
Trust in the accuracy of data collected through remote monitoring and security of personal data when using remote monitoring are evaluated to understand patient concerns regarding data security and privacy.
|
During a follow-up consultation within one year after major surgery
|
|
Needs regarding parameter collection
Time Frame: During a follow-up consultation within one year after major surgery
|
To understand patient needs regarding parameter collection, patients are asked if they think there is a need for additional parameters to be collected beyond vital signs (e.g., blood pressure, oxygen saturation, body temperature, heart rate), or if they have specific preferences for health parameters to be collected.
|
During a follow-up consultation within one year after major surgery
|
|
Skills regarding working with technology
Time Frame: During a follow-up consultation within one year after major surgery
|
To examine patients' skills regarding working with technology, skills in using technology, comfort using digital devices for health monitoring, and the need for training to use remote monitoring effectively will be investigated.
|
During a follow-up consultation within one year after major surgery
|
|
Desire for notifications when a parameter or questionnaire needs to be entered in an app
Time Frame: During a follow-up consultation within one year after major surgery
|
The desire for notifications when a parameter or questionnaire needs to be entered in an app, for alerts or alarms when a parameter is abnormal, for digital feedback from healthcare providers, or to communicate directly with healthcare providers through an app is explored to understand patient needs regarding the functioning of the digital monitoring care pathway.
|
During a follow-up consultation within one year after major surgery
|
|
Perceptions regarding the usefulness of a digital monitoring care pathway
Time Frame: During a follow-up consultation within one year after major surgery
|
To assess patient perceptions regarding the usefulness of a digital monitoring care pathway, their perception of the potential for remote monitoring to improve the recovery process, of benefits for patients/healthcare providers/society, of remote monitoring helping to reduce anxiety about recovery through continuous monitoring, and of remote monitoring helping to prevent complications, will be examined.
|
During a follow-up consultation within one year after major surgery
|
|
Willingness to participate in a study with remote monitoring
Time Frame: During a follow-up consultation within one year after major surgery
|
The willingness to participate in a study with remote monitoring is asked to assess patient willingness to participate in a study where digital monitoring is used.
|
During a follow-up consultation within one year after major surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 2, 2025
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
May 1, 2027
Study Registration Dates
First Submitted
May 27, 2025
First Submitted That Met QC Criteria
June 6, 2025
First Posted (Actual)
June 8, 2025
Study Record Updates
Last Update Posted (Actual)
June 8, 2025
Last Update Submitted That Met QC Criteria
June 6, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2025/046
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Digital Health
-
Jessa HospitalRecruitingDigital HealthBelgium
-
Jessa HospitalNot yet recruiting
-
China Medical University HospitalMinistry of Health and Welfare, TaiwanRecruitingHealthy Aging | Digital Health LiteracyUnited Kingdom
-
Bispebjerg HospitalRecruitingPhysical Activity | Digital Health | InpatientsDenmark, Faroe Islands, Greenland
-
Fondazione Don Carlo Gnocchi OnlusCarol Davila University of Medicine and Pharmacy; MEDEA SRL; Caritas Diocesana... and other collaboratorsActive, not recruiting
-
Jacobs University Bremen gGmbHHamburg University of Applied Sciences/Hochschule für Angewandte Wissenschaften...RecruitingDigital Health | Artificial Intelligence (AI)Germany
-
National University of SingaporeNot yet recruitingAged | Cognition | Digital Health LiteracySingapore
-
Institute for Digital Medicine (WisDM)Not yet recruitingHealthy | Digital Health | Incentive Interventions
-
Chang Gung Memorial HospitalRecruitingFamily | Nursing Home | Digital HealthTaiwan
-
Tri-Service General HospitalRecruitingHealthy Aging | Digital Health LiteracyTaiwan
Clinical Trials on Semi-structured interview
-
University Hospital, GrenobleNot yet recruiting
-
University Hospital, AntwerpRecruitingAnxiety | Elective Surgery | Chronic Post Surgical PainBelgium
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Multiple Sclerosis | Parkinson Disease | Rehabilitation | Neurologic Disorder | NeurosurgeryItaly
-
Assistance Publique - Hôpitaux de ParisURC Necker Cochin, FranceCompleted
-
Hospices Civils de LyonCompleted
-
University of OxfordCompletedCeliac Disease | Mental Health Wellness 1 | Emotional Problem | Stigma, Social | Celiac Disease in Children | Celiac | DisclosureUnited Kingdom
-
University Hospital, BordeauxCompleted
-
St Vincent's Hospital, SydneyUniversity of Technology, SydneyRecruitingProstate Cancer (Adenocarcinoma)Australia
-
Centre Hospitalier Universitaire de NīmesRecruitingAddictive Behavior | Gambling | Impulsivity | Boredom | Shift WorkFrance
-
University Hospital, Clermont-FerrandResearch on Healthcare Performance Lab U1290RecruitingJuvenile Idiopathic ArthritisFrance