Viewing Study NCT04768127



Ignite Creation Date: 2024-05-06 @ 3:48 PM
Last Modification Date: 2024-10-26 @ 1:57 PM
Study NCT ID: NCT04768127
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-07-09
First Post: 2020-12-16

Brief Title: Adipositas Care Health Therapy
Sponsor: Wuerzburg University Hospital
Organization: Wuerzburg University Hospital

Study Overview

Official Title: ACHT - Adipositas Care Health Therapy Zur Strukturierten sektorenübergreifenden Versorgung Nach Bariatrisch-metabolischer Operation
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ACHT
Brief Summary: ACHT - Adipositas Care and Health Therapy - is a structured digitally-supported cross-sectoral and close to home program developed for the postoperative care of patients following obesity surgery The aim is to ensure the long-term success of therapy following bariatric surgery ACHT was selected by the Federal Joint Commission for support under the Innovation Fund The project started in July 2019 and will end in December 2022
Detailed Description: In Germany every second adult is overweight and almost one in four is obese - the trend is rising Obesity is a chronic illness which significantly increases the risk of developing co-morbidities such as cardiovascular and joint diseases cancer and diabetes In addition to those functional and health limitations many people are stigmatised which can lead to social exclusion and a reduced quality of life Available conservative therapies do not always lead to sufficient long-term weight loss In those cases and if the disease is very pronounced an obesity surgery bariatric-metabolic surgery can help In order to ensure its success patients require long-term after care following surgery Currently there are no necessary outpatient care standards and provisions Inpatient obesity centres try to compensate for this with their own structures and limited resources but are already reaching their limits

The aim of the ACHT project is to ensure long-term therapeutic success after an operation This is done through a digitally supported structured cross-sectoral and close-to-home aftercare program Obesity case managers obesity guides coordinate the aftercare process and monitor the therapy goals A digital case file links patients case managers resident doctors and obesity centers Individual exercise goals nutritional advice and psychological support are part of ACHT ACHT is connected to quality assurance measures of a medical society

Four groups are compared in the ACHT study One group begins their 18 months ACHT aftercare program directly after the operation another group 18 months after the operation These two groups are compared to patients who receive standard care Through these two intervention groups we hope to examine the long-term effects of the program within the given time constraints of the study

ACHT is funded for three and a half years by the Federal Joint Committee as part of the Innovation Fund with approx 45 million euros

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None