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

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 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.

The primary objective is to assess the usability and feasibility of the VITAAAL
intervention as blended-care intervention. Secondary/exploratory objectives are
to evaluate clinical outcomes (e.g. Time in Range, estimated HbA1c, body
weight, and physical activity), psychological parameters (e.g. self-management
skills).

In a mixed methods single center pilot study, patients will undergo the VITAAAL
intervention during 4 to 8 weeks depending on their waiting time for their
surgical intervention. The study consists of three phases. The aim is to
include 6 patients in phase one and two and 12 patients in phase three. After
each phase, an interim analysis with questionnaires and an interview will be
performed to improve the VITAAAL intervention and a prehabilitation module will
be programmed in the Diameter app which will be used and evaluated in the
second and third phase of the pilot study. The intervention is preceded by a
three-day period of blinded baseline measurements.

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 NP to receive new instructions and/or to adapt
the goals. During admission for surgery patients keep measuring their physical
activity and glucose regulation as during the intervention, they do not keep
track of nutrition during admission. Interviews and questionnaires are
conducted shortly before admission. 12 weeks after surgery complications and
admission duration are identified.

Participation in the study requires two visits at the outpatient clinic.
Invasive measurements will not be performed. All other contacts are telephone-
or video calls. The total expected time burden for patients is 105 minutes for
two visits at the outpatient clinic and 20 minutes for each phone call.
Patients are asked to fill in questionnaires twice (at baseline and before
hospitalization) by regular post or secure email and a telephone interview
before admission with a total time of 53 minutes for all questionnaires and 45
minutes for an interview. Patients are required to use the Fitbit and Freestyle
Libre. The risks of participation on patients* health in all phases of this
study are minimal. Low glucose values can occur, but due to the intensive
contact with the NP diabetes, medication can be adjusted in time to prevent
hypoglycemia. Possible benefits for users are that the intervention may lead to
better glycemic control before surgery which reduces the risk of postoperative
complications, and the intervention could enhance patients* motivation and
competence to self-manage their lifestyle.