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

NCT ID: NCT06061406

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-02
• Study Completion Date: 2024-06-30

Brief 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.

Detailed Description

The prevalence of obesity has been increasing dramatically for decades. The comorbidities are manifold, and the treatment of obesity is a long-term, usually lifelong task. Metabolic-bariatric surgery offers the best results. However, even after bariatric-metabolic surgery, there is a need for lifelong follow-up to ensure the success of therapy and to identify and treat possible complications, nutritional problems or deficiencies in a timely manner.

The treating centers are increasingly overwhelmed by the follow-up care of the numerous patients. At the same time, the guidelines of the professional societies recommend involving the patient in the success of his or her therapy and enabling him or her to play an active role in shaping his or her treatment. An app tailored to the treatment of obese people, which helps both in the self-organization of the patients in complying with the therapy recommendations and in maintaining contact with the center on a permanent basis and making low-threshold contact when necessary, would be a valuable addition to the existing therapy options for patients and centers alike.

Such an app would also have its value in the preoperative patient, especially since a lot of documentation work has to be done by the patient in this phase.

Patients whose obesity is not pronounced enough for a surgical procedure often complete nutritional counseling and exercise at their own expense without receiving support from experts. Here, too, there would be a need to supplement the therapy options with an appropriately coordinated app.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group1

Bariatric-metabolic surgery (Gastric sleeve, Roux-Y gastric bypass, omega-loop bypass) at least 24 months ago, 25-45 patients in this group (total sum of patients in all three groups: 100).

Group Type: EXPERIMENTAL

smart visit app

Intervention Type: DEVICE

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.

group 2

Patients participating in a full or partial (if primary indication) multimodal approach prior to bariatric surgery, 25-45 patients in this group (total sum of patients in all three groups: 100).

Group Type: EXPERIMENTAL

smart visit app

Intervention Type: DEVICE

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.

group 3

Conservative therapy: patients with overweight/obesity grade 1 (BMI 28-34.9 kg/m2), 25-45 patients in this group (total sum of patients in all three groups: 100).

Group Type: EXPERIMENTAL

smart visit app

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Smartphone available (iOS or Android with sufficient version of the operating system).
• Age >/= 18 years
• Sufficient language skills to answer the questionnaires

Group 1 (bariatric-metabolic surgery):

• Bariatric-metabolic surgery (sleeve gastrectomy, Roux-Y gastric bypass, omega-loop bypass) at least 24 months ago.

Group 2 (multimodal treatment):

• Participation in a full or partial (if primary indication) multimodal approach.

Group 3 (conservative therapy):

• BMI 28-34.9 kg/m2
• No planned bariatric-metabolic surgery
• Desire for conservative weight reduction

Exclusion Criteria

• current pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

Wuerzburg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ann-Cathrin Koschker

Head of outpatient clinic for diabetes and lipids

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann-Cathrin D Koschker

Role: PRINCIPAL_INVESTIGATOR

University Hospital Wuerzburg

Locations

Ann-Cathrin D Koschker

Würzburg, , Germany

Countries

Germany

Other Identifiers

BESmart 228/20

Identifier Type: -

Identifier Source: org_study_id