Prehabilitation program using technology for diabetes patients undergoing vascular surgery
Nursing Prehabilitation Intervention Supported With Technology for Vascular Surgery in People With Type 2 Diabetes
This study is testing a technology-based program to help people with Type 2 Diabetes get healthier before their vascular surgery to see if it can lead to better recovery and fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ziekenhuisgroep Twente Academic / other |
| Locations | 1 site (Almelo, Overijssel) |
| Trial ID | NCT06248775 on ClinicalTrials.gov |
What this trial studies
This study aims to implement a prehabilitation intervention for patients with Type 2 Diabetes Mellitus (T2DM) who are scheduled for vascular surgery. The intervention utilizes technology such as continuous glucose sensors and activity trackers to monitor lifestyle changes and improve glucose regulation before surgery. By enhancing patients' fitness levels and glycemic control, the study seeks to reduce postoperative complications and improve overall surgical outcomes. The approach is designed to be less labor-intensive than traditional methods, making it more feasible for standard care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Type 2 Diabetes who require scheduled vascular surgery.
Not a fit: Patients needing acute vascular surgery or those with severe diabetic complications may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could lead to improved surgical outcomes and reduced healthcare costs for patients with Type 2 Diabetes.
How similar studies have performed: While the use of technology in prehabilitation is promising, this specific approach has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with T2DM who need a scheduled vascular surgery, consisting of AAA surgery endovascular or classical abdominal approach, aortic stenosis surgery or Fontaine II. * Aged 18 years or older * Being familiar with using an Android smartphone (version 5.0 or higher); * Participant can understand and weigh up information provided by researcher and can understand what the consequences of participation are. Exclusion Criteria: * Need for acute vascular surgery * Dependency on renal replacement therapy * Known with (pre)proliferative diabetic retinopathy with or without macula oedema. * Any general diseases or mental disorder rendering participation in the study impossible * Drug abuse * Insufficient mastery of the Dutch language
Where this trial is running
Almelo, Overijssel
- Ziekenhuisgroep Twente — Almelo, Overijssel, Netherlands (Recruiting)
Study contacts
- Study coordinator: G.D. Laverman, Prof. Dr.
- Email: g.laverman@zgt.nl
- Phone: 003188-7084351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.