Nursing Prehabilitation Intervention Supported With Technology for Vascular Surgery in People With Type 2 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- Nicole Oosterom
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Acceptability of the VITAAAL intervention
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Nicole Oosterom
MSc
Ziekenhuisgroep Twente
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
Outcomes
Primary Outcomes
Acceptability of the VITAAAL intervention
Time Frame: 4 to 8 weeks prior surgery
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.
usability of the VITAAAL intervention
Time Frame: 4 to 8 weeks prior surgery
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
Secondary Outcomes
- Glycemic regulation - Time Above Range (TAR)(4 to 8 weeks prior surgery)
- Glycemic regulation - Time in Range(4 to 8 weeks prior surgery)
- Medication usage(4 to 8 weeks prior surgery)
- HbA1c(4 to 8 weeks prior surgery)
- Glucose management indicator (GMI)(4 to 8 weeks prior surgery)
- Blood pressure(4 to 8 weeks prior surgery)
- Self-management(4 to 8 weeks prior surgery)
- Cholesterol(4 to 8 weeks prior surgery)
- Morning void urine(4 to 8 weeks prior surgery)
- Glycemic regulation - Time Below Range (TBR)(4 to 8 weeks prior surgery)
- Physical activity(4 to 8 weeks prior surgery)
- fasting glucose(4 to 8 weeks prior surgery)
- eGFR(4 to 8 weeks prior surgery)
- Mean levels of sensor-measured interstitial glucose concentration(4 to 8 weeks prior surgery)
- Glycaemic variability (GV)(4 to 8 weeks prior surgery)
- Clinical outcomes(4 to 8 weeks prior surgery)
- Peripheral neuropathy(4 to 8 weeks prior surgery)
- Nutritional behavior(4 to 8 weeks prior surgery)
- Treatment adherence(4 to 8 weeks prior surgery)
- Stages of change(4 to 8 weeks prior surgery)
- Self-efficacy(4 to 8 weeks prior surgery)
- Health-related quality of life(4 to 8 weeks prior surgery)