Clinical trial NCT06248775: Nursing Prehabilitation Intervention Supported With Technology for Vascular Surgery in People With Type 2 Diabetes
Official title: Nursing Prehabilitation Intervention Supported With Technology for Vascular Surgery in People With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lifestyle
Prehabilitation
Vascular Surgery
Lead sponsor: Ziekenhuisgroep Twente
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


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

Primary outcomes:
measure: usability of the VITAAAL intervention
timeFrame: 4 to 8 weeks prior surgery
measure: Acceptability of the VITAAAL intervention
timeFrame: 4 to 8 weeks prior surgery
Secondary outcomes:
measure: Glycemic regulation - Time in Range
timeFrame: 4 to 8 weeks prior surgery
measure: Glycemic regulation - Time Above Range (TAR)
timeFrame: 4 to 8 weeks prior surgery
measure: Glycemic regulation - Time Below Range (TBR)
timeFrame: 4 to 8 weeks prior surgery
measure: Glucose management indicator (GMI)
timeFrame: 4 to 8 weeks prior surgery
measure: Mean levels of sensor-measured interstitial glucose concentration
timeFrame: 4 to 8 weeks prior surgery
measure: Glycaemic variability (GV)
timeFrame: 4 to 8 weeks prior surgery
measure: Clinical outcomes
timeFrame: 4 to 8 weeks prior surgery
measure: Medication usage
timeFrame: 4 to 8 weeks prior surgery
measure: Blood pressure
timeFrame: 4 to 8 weeks prior surgery
measure: Peripheral neuropathy
timeFrame: 4 to 8 weeks prior surgery
measure: HbA1c
timeFrame: 4 to 8 weeks prior surgery
measure: Physical activity
timeFrame: 4 to 8 weeks prior surgery
measure: Nutritional behavior
timeFrame: 4 to 8 weeks prior surgery
measure: Treatment adherence
timeFrame: 4 to 8 weeks prior surgery
measure: Self-efficacy
timeFrame: 4 to 8 weeks prior surgery
measure: Self-management
timeFrame: 4 to 8 weeks prior surgery
measure: Stages of change
timeFrame: 4 to 8 weeks prior surgery
measure: Health-related quality of life
timeFrame: 4 to 8 weeks prior surgery
measure: fasting glucose
timeFrame: 4 to 8 weeks prior surgery
measure: Cholesterol
timeFrame: 4 to 8 weeks prior surgery
measure: eGFR
timeFrame: 4 to 8 weeks prior surgery
measure: Morning void urine
timeFrame: 4 to 8 weeks prior surgery
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
state: Overijssel
Study officials:
References: