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

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

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

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.

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