NCT06248775

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Nicole Oosterom · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Type 2 Diabetes Mellitus (T2DM) is the most common chronic lifestyle-related disorder with a significant impact on quality and healthcare expenditures. Insufficient glycemic control and low fitness level prior to a surgical intervention results in more postoperative complications which leads to a longer hospitalization, higher costs and mortality. A prehabilitation intervention in persons with T2DM prior to surgery should be aimed to improve glucose regulation and translate into better outcomes. However, the classic interventions such as Combined Lifestyle Intervention are labor-intensive and require a high degree of organization and therefore are not used as standard care. The use of biofeedback can provide a solution to this. Biofeedback with a continuous glucose sensor in combination with lifestyle monitoring by activity trackers and coaching prior to surgery is a promising but unexplored prehabilitation strategy. The Nursing Prehabilitation Intervention Supported with Technology for vascular Surgery in People with Type 2 Diabetes (VITAAAL) intervention is a form of blended care. It focuses on improving vitality and glycemic control before surgery with the Diameter application, using intermittently scanned glucose monitoring, nutrition habits and physical activity blended with coaching from a nurse practitioner (NP) diabetes. Because VITAAAL is a novel intervention, the aim of this pilot study is to investigate its usability and feasibility. The pilot study consists of three phases. After the first phase, a specific prehabilitation module will be designed and programmed in the Diameter app. This module will be based on the results and experiences in phase one. In phase two and three the patients will use the adjusted version of the Diameter app that contains implemented findings of the previous phase.

Conditions

• Type 2 Diabetes
• Lifestyle
• Prehabilitation
• Vascular Surgery

Interventions

Type	Name	Description
BEHAVIORAL	Prehabilitation Intervention Supported with Technology (Fitbit, glucose sensor and app for diet habits)	During the VITAAAL intervention patients use the Diameter app to monitor their physical activities (in connection with a Fitbit), nutrition (using the Diameter app) and glucose levels (in connection with Freestyle Libre 2 sensors). Before the intervention starts, a three-day period of blinded baseline measurements is performed to measure current habits, motivation and possibilities. Then, individual aims for improving vitality are formulated in consultation with the NP diabetes. Afterwards, patients continue measuring their habits unblinded with the Diameter for the following weeks and weekly evaluate their goals with the nurse practitioner to receive new instructions and/or to adapt the goals

Timeline

• Start date: 2023-11-16
• Primary completion: 2025-01-01
• Completion: 2025-06-01
• First posted: 2024-02-08
• Last updated: 2024-02-08

Locations

1 site across 1 country: Netherlands