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

Nicole Oosterom

Status: Enrolling

Conditions: Lifestyle; Vascular Surgery; Type 2 Diabetes; Prehabilitation

Treatments: Behavioral: Prehabilitation Intervention Supported with Technology (Fitbit, glucose sensor and app for diet habits)

Study type: Interventional

Funder types: Other

Identifiers

NCT06248775

W2310 0450

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Nursing prehabilitation intervention group

Other group

Description:

Patients all undergo the intervention aimed at lifestyle improvement and glucose regulation

Treatment:

Behavioral: Prehabilitation Intervention Supported with Technology (Fitbit, glucose sensor and app for diet habits)