Digital HealthNCT07010055
Using Digital Health in a Postoperative Setting After Major Surgery: Semi-structured Interview Study
A study testing Semi-structured interview in people with Digital Health, run by Jessa Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digital Health
- What is being tested?
- Semi-structured interview
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Surgical patients
- >18 years old, Undergone major surgery at Jessa Hospital Hasselt
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Digital Health
- Being tested
- Semi-structured interview
- Keywords
- Remote monitoring, Major surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| Semi-structured interview | Experimental | Conducting a semi-structured interview during a follow-up consultation after major surgery Receives: Procedure: Semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for monitoring of vital and subjective parameters after discharge
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.
Measured: During a follow-up consultation within one year after major surgery
Secondary outcomes (10)
Perceptions regarding the implementation of digital monitoring care pathways
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.
Measured: During a follow-up consultation within one year after major surgery
Willingness to participate in digital care pathways
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.
Measured: During a follow-up consultation within one year after major surgery
Potential barriers to adopt digital care
To identify potential barriers to adopt digital care, challenges in using remote care will be surveyed.
Measured: During a follow-up consultation within one year after major surgery
Concerns about safety
Patients' concerns about safety when being discharged earlier with remote monitoring in place are assessed to understand patient concerns about their own safety.
Measured: During a follow-up consultation within one year after major surgery
Accuracy of data
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.
Measured: During a follow-up consultation within one year after major surgery
Needs regarding parameter collection
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.
Measured: During a follow-up consultation within one year after major surgery
Skills regarding working with technology
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.
Measured: 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
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.
Measured: During a follow-up consultation within one year after major surgery
Perceptions regarding the usefulness of a digital monitoring care pathway
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.
Measured: During a follow-up consultation within one year after major surgery
Willingness to participate in a study with remote monitoring
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.
Measured: During a follow-up consultation within one year after major surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start2 Jun 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital HealthStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010055
- Sponsor's protocol ID
- 2025/046
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Digital Health in a Postoperative Setting After Major Surgery: a Prospective Single-center Qualitative Semi-structured Interview Study
- ClinicalTrials.gov ID
- NCT07010055
- Acronym / sponsor ID
- 2025/046
- Conditions
- Digital Health
- Keywords
- Remote monitoring, Major surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 2 Jun 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 8 Jun 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semi-structured interview | Experimental | Procedure: Semi-structured interviewConducting a semi-structured interview during a follow-up consultation after major surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surgical patients
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Semi-structured interviewA semi-structured interview will be conducted once in-person to each patient after a follow-up consultation in the hospital after their major surgery | Procedure or surgery | Semi-structured interview |
Primary outcome
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.
10 secondary outcomes
Perceptions regarding the implementation of digital monitoring care pathways
Time frame: 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
Potential barriers to adopt digital care
Time frame: 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
Accuracy of data
Time frame: 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
Skills regarding working with technology
Time frame: 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
Perceptions regarding the usefulness of a digital monitoring care pathway
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
Related trials for Digital Health
Recruiting
The Effect of Digitally Enabled District (DED 2.0) Ecosystem on the Completeness and Timeliness of Maternal and Neonatal Services in Primary Health Care
Digital Health, Maternal Health Services
Not yet recruiting
Project GAME ON! A Digital Comic Tool to Promote Healthy Behaviors
Obesity & Overweight, Childhood
Not yet recruiting
Artificial Intelligence and Digital Health Literacies Among Older Adults: A Mixed-method Pilot Intervention Study
Digital Health Literacy, AI Chatbot
Not yet recruiting
The Effects of a Scenario-based Fact-checking Course on eHealth Literacy and Fact-checking Skills Among Older Adults.
eHealth Literacy, Digital Health Literacy
Recruiting
The e-SINCERE Study
Social Determinants of Health (SDOH), Digital Health Literacy
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.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-structured interview in people with Digital Health, run by Jessa Hospital.
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 3 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: opening soon, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bjorn Stessel, MD, PhD (+3211222107, bjorn.stessel@jessazh.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for monitoring of vital and subjective parameters after discharge (time frame: During a follow-up consultation within one year after major surgery). 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 8 Jun 2025.