Nursing Prehabilitation Intervention Supported With Technology for

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06248775
Study type	Interventional
Source	Ziekenhuisgroep Twente
Contact	G.D. Laverman, Prof. Dr.
Phone	003188-7084351
Email	g.laverman@zgt.nl
Status	Recruiting
Phase	N/A
Start date	November 16, 2023
Completion date	June 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05219994` - Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum	N/A
Completed	`NCT04056208` - Pistachios Blood Sugar Control, Heart and Gut Health	Phase 2
Completed	`NCT02284893` - Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone	Phase 3
Completed	`NCT04274660` - Evaluation of Diabetes and WELLbeing Programme	N/A
Active, not recruiting	`NCT05887817` - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)	Phase 4
Active, not recruiting	`NCT05566847` - Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes	N/A
Recruiting	`NCT06007404` - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Completed	`NCT04965506` - A Study of IBI362 in Chinese Patients With Type 2 Diabetes	Phase 2
Recruiting	`NCT06115265` - Ketogenic Diet and Diabetes Demonstration Project	N/A
Active, not recruiting	`NCT03982381` - SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes	Phase 4
Completed	`NCT04971317` - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages	N/A
Completed	`NCT04496154` - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood	N/A
Completed	`NCT04023539` - Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes	N/A
Recruiting	`NCT05572814` - Transform: Teaching, Technology, and Teams	N/A
Enrolling by invitation	`NCT05530356` - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Completed	`NCT04097600` - A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets	Phase 1
Completed	`NCT03960424` - Diabetes Management Program for Hispanic/Latino	N/A
Completed	`NCT05378282` - Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
Recruiting	`NCT06010004` - A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes	Phase 3
Completed	`NCT03653091` - Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms