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

NCT06248775 | Recruiting

• 1 other identifier: W2310 0450
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Lifestyle; Prehabilitation; Vascular Surgery

Outcome Measures

Primary Outcomes (2)

• usability of the VITAAAL intervention

  Usability will be assessed by means of an open-ended interview. The purpose of the interview is to gain insight into the experiences with the VITAAAL intervention regarding usability to identify user problems. To investigate the usability of the VITAAAL intervention, an interview scheme has been drawn up. The following topics will be discussed: overall experience, learnability, efficiency, memorability, satisfaction, errors and positive and negative elements

  4 to 8 weeks prior surgery

• Acceptability of the VITAAAL intervention

  Acceptability will be assessed using the UTAUT2 questionnaire. The UTAUT2 questionnaire consists of 19 questions. The UTAUT2 determinants include performance expectancy, effort expectancy, pleasure/hedonic motivation, facilitating circumstances, design, technical issues and habit. In addition, we will ask about the (potential) contribution of the VITAAAL intervention, the 3 most positive and negative aspects of the VITAAAL intervention and an overall rating expressed in a score on a scale of 1 to 10 (1 = extremely poor, 10 = excellent). The experiences with the VITAAAL intervention will be assessed using multiple statements generated by the research team according to literature and previous used UTAUT2-model based questionnaires. Each statement will be scored on a 7-point Likert scale (1 = extremely disagree, 7 = extremely agree) where a higher score indicate positive experiences with the VITAAAL intervention.

  4 to 8 weeks prior surgery

Secondary Outcomes (22)

• Glycemic regulation - Time in Range

  4 to 8 weeks prior surgery

• Glycemic regulation - Time Above Range (TAR)

  4 to 8 weeks prior surgery

• Glycemic regulation - Time Below Range (TBR)

  4 to 8 weeks prior surgery

• Glucose management indicator (GMI)

  4 to 8 weeks prior surgery

• Mean levels of sensor-measured interstitial glucose concentration

  4 to 8 weeks prior surgery

Study Arms (1)

Nursing prehabilitation intervention group

OTHER

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

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

Interventions

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

Nursing prehabilitation intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicole Oosterom: lead

Study Sites (1)

Ziekenhuisgroep Twente

Almelo, Overijssel, 7609PP, Netherlands

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Technology; Amyloid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture; Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

G.D. Laverman, Prof. Dr.

CONTACT

003188-7084351; g.laverman@zgt.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: February 8, 2024
• Study Start: November 16, 2023
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)