AzTrials
AzTrials

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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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.

Bjorn Stessel, MD, PhD contact

+3211222107

bjorn.stessel@jessazh.be

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 groups in NCT07010055
Study groupRoleWhat they receive
Semi-structured interviewExperimentalConducting 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  1. First posted8 Jun 2025
  2. Study start2 Jun 2025 (estimated)
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in