Digital HealthNCT07010081
Using Digital Health in a Postoperative Setting After Major Surgery: Survey Study
A study testing Surveys in people with Digital Health, run by Jessa Hospital at 1 site in Belgium.
Trial summary
This study aims to explore patients' use of digital services for self-management of their health following major surgery at Jessa Hospital. Besides this, the study evaluates patients' ability to process and critically assess health information during recovery, their understanding of health concepts and risk factors… 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?
- Surveys
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteBelgium
- Study dates
- 26 May 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Jessa Hospital
Hasselt, Limburg, 3500
Ina Callebaut, PhD, 003211339848, ina.callebaut@jessazh.be
About this study
Official title: Using Digital Health in a Postoperative Setting After Major Surgery: a Prospective Single-center Quantitative Survey Study
This study aims to explore patients' use of digital services for self-management of their health following major surgery at Jessa Hospital. Besides this, the study evaluates patients' ability to process and critically assess health information during recovery, their understanding of health concepts and risk factors, and their perception of data security and control over personal health information. Additionally, the study aims to examine patients' motivation to use digital services, their access to and trust in reliable digital health resources, and how well these services meet their individual needs. Furthermore, the study assesses the acceptability, appropriateness, and feasibility of using digital health tools in a post-operative setting, as well as evaluating the digital readiness of patients after surgery.
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
- Surveys
- Keywords
- Remote monitoring, Major surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysProcedure or surgery
Several questionnaires 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 |
|---|---|---|
| Surveys | Experimental | Conducting questionnaires during a follow-up consultation after major surgery Receives: Procedure: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' understanding of comfort and engagement with using digital services for self- management of their disease
The patients' understanding of comfort and engagement with using digital services for self- management of their disease after major surgery will be evaluated using scale 4 of the eHLQ.
Measured: During a follow-up consultation within one year after major surgery
Secondary outcomes (9)
Ability of patients to use technology to process and critically evaluate health information
The ability of patients to use technology to process and critically evaluate health information during postoperative recovery will be evaluated using scale 1 of the eHLQ.
Measured: During a follow-up consultation within one year after major surgery
Patients' understanding of health concepts, their health status, and risk factors
Scale 2 of the eHLQ will assess patients' understanding of health concepts, their health status, and risk factors during their recovery period.
Measured: During a follow-up consultation within one year after major surgery
Patients' perception of data security and control over personal health data
To assess patients' perception of data security and control over personal health data in digital services, scale 4 of the eHLQ will be used.
Measured: During a follow-up consultation within one year after major surgery
Patients' motivation to use digital services for managing postoperative health
Scale 5 of the eHLQ is used to examine patients' motivation to use digital services for managing their postoperative health.
Measured: During a follow-up consultation within one year after major surgery
Patients' access to and trust in reliable digital health services
The sixth scale of the eHLQ will evaluate patients' access to and trust in reliable digital health services during recovery.
Measured: During a follow-up consultation within one year after major surgery
The extent to which digital health services meet patients' individual needs and preferences
To assess how well digital health services meet patients' individual needs and preferences during recovery, scale 7 of the eHLQ will be used.
Measured: During a follow-up consultation within one year after major surgery
Acceptability, appropriateness, and feasibility of using digital health by means of implementation outcome measures AIM, IAM, and FIM
To evaluate the acceptability, appropriateness, and feasibility of using digital health in a postoperative setting after major surgery, the AIM, IAM, and FIM, respectively, will be used.
Measured: During a follow-up consultation within one year after major surgery
Digital readiness
The DHRQ will be used to assess digital readiness of patients that underwent major surgery.
Measured: During a follow-up consultation within one year after major surgery
External validation of the digital health readiness questionnaire
The DHRQ will be externally validated against the extensively validated eHLQ.
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 start26 May 2025
- 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
- 220 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
- NCT07010081
- Sponsor's protocol ID
- 2025/047
- Status last verified
- Sep 2025
- First submitted
- 27 May 2025
- Last updated
- 1 Oct 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 1 Oct 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 Quantitative Survey Study
- ClinicalTrials.gov ID
- NCT07010081
- Acronym / sponsor ID
- 2025/047
- Conditions
- Digital Health
- Keywords
- Remote monitoring, Major surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 26 May 2025 (actual)
- 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 explore patients' use of digital services for self-management of their health following major surgery at Jessa Hospital. Besides this, the study evaluates patients' ability to process and critically assess health information during recovery, their understanding of health concepts and risk factors, and their perception of data security and control over personal health information. Additionally, the study aims to examine patients' motivation to use digital services, their access to and trust in reliable digital health resources, and how well these services meet their individual needs. Furthermore, the study assesses the acceptability, appropriateness, and feasibility of using digital health tools in a post-operative setting, as well as evaluating the digital readiness of patients after surgery.
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 |
|---|---|---|
| Surveys | Experimental | Procedure: SurveysConducting questionnaires 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 |
|---|---|---|
| SurveysSeveral questionnaires will be conducted once in-person to each patient after a follow-up consultation in the hospital after their major surgery | Procedure or surgery | Surveys |
Primary outcome
Patients' understanding of comfort and engagement with using digital services for self- management of their disease
Time frame: During a follow-up consultation within one year after major surgery
The patients' understanding of comfort and engagement with using digital services for self- management of their disease after major surgery will be evaluated using scale 4 of the eHLQ.
9 secondary outcomes
Ability of patients to use technology to process and critically evaluate health information
Time frame: During a follow-up consultation within one year after major surgery
Patients' understanding of health concepts, their health status, and risk factors
Time frame: During a follow-up consultation within one year after major surgery
Patients' perception of data security and control over personal health data
Time frame: During a follow-up consultation within one year after major surgery
Patients' motivation to use digital services for managing postoperative health
Time frame: During a follow-up consultation within one year after major surgery
Patients' access to and trust in reliable digital health services
Time frame: During a follow-up consultation within one year after major surgery
The extent to which digital health services meet patients' individual needs and preferences
Time frame: During a follow-up consultation within one year after major surgery
Acceptability, appropriateness, and feasibility of using digital health by means of implementation outcome measures AIM, IAM, and FIM
Time frame: During a follow-up consultation within one year after major surgery
Digital readiness
Time frame: During a follow-up consultation within one year after major surgery
External validation of the digital health readiness questionnaire
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 1 Oct 2025.
Related trials for Digital Health
RecruitingObservational study
Activation Sarcoma: PROMIS and Mobility Evaluation in Sarcoma Patients
Sarcoma, Giant Cell Tumor of Bone
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
Active, not recruiting
AI Mental Health Tool vs. Psychoeducation Control
Depressive Disorder, Depressive Symptoms
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surveys in people with Digital Health, run by Jessa Hospital at 1 site in Belgium.
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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Patients' understanding of comfort and engagement with using digital services for self- management of their disease (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 1 Oct 2025.