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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-16

Study Completion Date

2025-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Lifestyle Prehabilitation Vascular Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Nursing prehabilitation intervention group

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

Group Type OTHER

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

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No