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Recruiting NCT07297342

A Prospective Randomnised Controlled Trial Comparing Overall Patient Compliance in a Bariatric Surgical Pathway Using the Standard Versus a More Intensified and Interactive Version of the "Get Ready" Smartphone Application.

No phase Interventional Obesity &Amp; Overweight Hypertension Obstructive Sleep Apnea (OSAS) Diabetes Mellitus ( Type 1 and Type 2)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GetReady application, Intensified GetReady application.
Who it may be relevant to
Registry conditions: Obesity &Amp; Overweight, Hypertension, Obstructive Sleep Apnea (OSAS), Diabetes Mellitus ( Type 1 and Type 2). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The aim of this study is to assess the impact of a newly intensified digital platform following bariatric surgery. This will be measured using several questionnaires. The following objectives will be evaluated: the exact amount of weight loss achieved preoperatively with the preparatory diet; the occurrence of dumping symptoms; the assessment of quality of life (QOL); and compliance with supplement intake. By examining the impact of an enhanced digital platform, we aim to address critical questions regarding the effectiveness of improved patient support in the digital domain. Moreover, given the increasing prevalence of bariatric surgery as a therapeutic option for obesity, it is of utmost importance to identify strategies to optimize patient education and support through digital tools. This study not only contributes to the scientific understanding of digital support in bariatric care but also has important implications for the further development of the "Get Ready" application, ensuring that it remains at the forefront of providing comprehensive and patient-centered support in the evolving landscape of bariatric surgery.

Interventions

  • Other GetReady application
    Postoperative application usage
  • Other Intensified GetReady application
    Postoperative application usage

Primary outcome measures

  • Weight [Time frame: 3monts, 6 months, 12 months]
  • Rand-36 Health Survey [Time frame: 12months]
  • Bloodwork [Time frame: 6 months and 12 months]
  • Sigstad score [Time frame: 3months, 6 months and 122 months]
Secondary outcome measures (1)
  • N° of unplanned clinical visits [Time frame: 12months]

Eligibility criteria

Inclusion criteria

  • Patients undergoing bariatric surgery

Exclusion criteria

  • Previous bariatric surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Belgium · 1 center
  • Sint Dimpna ziekenhuis — Geel

Identifiers

NCT: NCT07297342 · ERP-2023-13530

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗