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Search / Trial NCT06248775

Nursing Prehabilitation Intervention Supported With Technology for Vascular Surgery in People With Type 2 Diabetes

Launched by NICOLE OOSTEROM · Feb 5, 2024

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, called VITAAAL, is investigating a new way to prepare patients with Type 2 Diabetes (T2DM) for upcoming vascular surgeries. The goal is to help improve their blood sugar control and overall health before surgery, which can lead to better recovery outcomes. Participants will use a special app called Diameter, which works with a glucose monitor and activity trackers, and they will receive guidance from a nurse practitioner. This approach aims to make it easier for patients to manage their health and lifestyle before their surgery.

To be eligible for this trial, participants need to be 18 years or older, have T2DM, and be scheduled for specific vascular surgeries. They should also be comfortable using an Android smartphone. However, individuals who require emergency surgery, have certain eye complications from diabetes, or have serious health issues that might affect their participation cannot join. Those who take part can expect a supportive environment where they’ll receive tailored coaching and technology to help them prepare for their surgery effectively.

Gender

ALL

Eligibility 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

About Nicole Oosterom

Nicole Oosterom is a dedicated clinical trial sponsor with extensive experience in the biomedical research field. She is committed to advancing healthcare through innovative clinical studies that prioritize patient safety and efficacy. With a strong background in regulatory compliance and a keen understanding of the complexities of trial management, Nicole fosters collaboration between research teams, healthcare professionals, and regulatory bodies to ensure the successful execution of clinical trials. Her focus on ethical practices and data integrity underpins her mission to contribute to the development of groundbreaking therapies and improve patient outcomes.

Locations

Almelo, Overijssel, Netherlands

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported