BE Smart - Bariatric Patient - Empowerment in the Preparation and Follow-up of Bariatric Surgery Using the Smartvisit App (BESmart)

NCT06061406 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-04-24

No results posted yet for this study

Summary

Obesity affects an increasing proportion of the population and is associated with numerous comorbidities that cause increased morbidity and mortality.

The most effective therapy for morbid obesity is metabolic bariatric surgery. Surgical numbers are increasing worldwide. Before surgery, patients must try to reduce weight conservatively in a multimodal therapy concept. In addition, numerous protocols must be collected and appointments must be organized. Postoperatively, patients are expected to receive lifelong follow-up care, which increasingly overwhelms bariatric centers.

People with overweight and obesity ° I are often left largely alone with the treatment of their disease. There is a considerable gap in care here.

For the care of patients with obesity and empowerment in dealing with their disease, the smart visit app from the company aycan, which is adapted to obesity patients, is to be investigated. This is designed as a pilot project with the primary endpoint of usage and satisfaction (after 3 months, key secondary endpoint after 12 months). A total of 100 patients from 3 groups (postoperative, preoperative, permanent conservative with only overweight/obesity °I) will use the app for 1 year for this purpose.

Conditions

  • Obesity
  • Bariatric Surgery Candidate

Interventions

DEVICE

smart visit app

Patients use an obesity-adapted version of aycan's Smartvisit app, which helps track specific behaviors (diet, exercise), query potential problems/complaints, and manage medical documents in a structured way. A study nurse experienced in the field of nutrition/obesity contacts the patient if necessary and establishes contact with the center physician.

Sponsors & Collaborators

  • aycan Medical Systems LTD, Innere Aumuehlstr. 5, 97076 Wuerzburg , Germany

    collaborator UNKNOWN
  • Wuerzburg University Hospital

    lead OTHER

Principal Investigators

  • Ann-Cathrin D Koschker · University Hospital Wuerzburg

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-02
Primary Completion
2023-10-31
Completion
2024-06-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06061406 on ClinicalTrials.gov