Clinical trial NCT04768127: Adipositas Care & Health Therapy
Official title: ACHT - Adipositas Care & Health Therapy Zur Strukturierten, sektorenübergreifenden Versorgung Nach Bariatrisch-metabolischer Operation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Patients After Metabolic-bariatric Surgery
Obesity, Morbid
Keywords: bariatric surgery
patient adherence
post surgery care
morbid obesity
obesity surgery
obesity guide
aftercare program
electronic case file
obesity app
weight loss surgery
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: Deutsche Stiftung für chronisch Kranke
name: Deutschen Gesellschaft für Allgemein- und Viszeralchirurgie e.V. (DGAV)
name: AOK Bayern
name: Kassenärztliche Vereinigung Bayern
name: symeda GmbH
name: AMC Wolfartklinik Gräfelfing
name: Schön Klinik Nürnberg Fürth
name: Dr. Lubos Kliniken Bogenhausen
name: Klinikum Memmingen
name: Klinikum Passau
name: Klinikum Nürnberg
name: Helmholtz Zentrum München
First posted: 2021-02-24
Enrollment: 586
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will compare two intervention groups (early intervention and later intervention) to two control groups.
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 4.5 million euros.

Eligibility criteria: Inclusion Criteria:

relevant for all groups:

* patients who have already approved to have their data entered into the National Registry of metabolic and bariatric diseases (StuDoQ, DGAV)
* Sufficient knowledge of the German language to use the app, to communicate with the obesity case manager (obesity guide) and to fill out the questionnaires
* signed consent form

group specific criteria:

Intervention group I ("early aftercare"):

* Insured with the Allgemeine Ortskrankenkasse (AOK) Bayern
* Consent to participate in the selective contract
* The bariatric metabolic operation (sleeve gastrectomy, Roux-en-Y-gastric bypass) was carried out 3 weeks (+/- 10 days) before the entrance examination
* iOS or Android smartphone (operating system: iOS 11 or higher or Android 6 or higher) with internet access can be used for study
* Sufficient mobility to get to the aftercare practice regularly and to complete an exercise program

Intervention Group II ("medium-term and late after care") recruited from control group I:

* Insured with the Allgemeine Ortskrankenkasse (AOK) Bayern
* Consent to participate in the selective contract
* The bariatric-metabolic operation (sleeve gastrectomy or Roux-en-Y-gastric bypass) was carried out 18 months (+/- 2 months) before time of recruitment

Control group I (compared to early intervention):

* Insured with the Allgemeine Ortskrankenkasse (AOK) Bayern
* The bariatric metabolic operation was carried out 18 months (+/- 2 months) before time of recruitment
* Sufficient mobility (see intervention group, so that groups are comparable)

Control group II (compared to late intervention):

* The bariatric metabolic operation was carried out 36 months (+/- 2 months) before the recruitment date
* Sufficient mobility (see intervention group, so that groups are comparable)
* The health insurance is irrelevant in this group

Exclusion Criteria:

* State after a revision operation
* Planned two-stage surgical procedure

Primary outcomes:
measure: Modified King's Score (comparison between intervention group I and control group I resp. intervention group II and control group II)
timeFrame: 18 months
Secondary outcomes:
measure: General Quality of life
timeFrame: 18 months
measure: Bariatric Quality of life
timeFrame: 18 months
measure: Health-specific Quality of life
timeFrame: 18 months
measure: - Depression
timeFrame: 18 months
measure: - Single dimensions of the modified King's Score
timeFrame: 18 months
measure: Percentage of Patients with folic acid deficiency
timeFrame: 18 months
measure: Percentage of Patients with Vitamin B 12 deficiency
timeFrame: 18 months
measure: Percentage of Patients with Vitamin B 1 deficiency
timeFrame: 18 months
measure: Percentage of Patients with Vitamin B 6 deficiency
timeFrame: 18 months
measure: Percentage of Patients with iron deficiency
timeFrame: 18 months
measure: Percentage of Patients with protein deficiency
timeFrame: 18 months
measure: Percentage of patients with symptoms of postoperative malnutrition based on 9 standardized questions
timeFrame: 18 months
measure: Percentage of Procedure-specific long term complications: Dumping syndrome
timeFrame: 18 months
measure: Percentage of Procedure-specific long term complications: gastric ulcers
timeFrame: 18 months
measure: Percentage of Procedure-specific long term complications: gall stones
timeFrame: 18 months
measure: Percentage of Procedure-specific long term complications: internal hernia
timeFrame: 18 months
measure: percentage of procedure-specific long term complications: anastomosis Stenosis
timeFrame: 18 months
measure: Change in lean Body mass
timeFrame: 18 months
measure: Change in Phase angle
timeFrame: 18 months
measure: average number of Sick days
timeFrame: 18 months
measure: - Patient adherence
timeFrame: 18 months
measure: Percentage of patients reaching their Goal for steps per day
timeFrame: 18 months
measure: Percentage of patients reaching their Treatment Goal for physical activity
timeFrame: 18 months
measure: - Acceptance of the ACHT aftercare program
timeFrame: 18 months
Other outcomes:
Locations:
city: Gräfelfing
country: Germany
facility: AMC WolfartKlinik, Zentrum für Adipositas- und Metabolische Chirurgie
city: Memmingen
country: Germany
facility: Adipositaszentrum Klinikum Memmingen
city: München
country: Germany
facility: Chirurgische Klinik München-Bogenhausen GmbH
city: Nürnberg
country: Germany
facility: Klinikum Nürberg
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach GmbH
city: Passau
country: Germany
facility: Klinikum Passau
city: Wuerzburg
country: Germany
facility: Wuerzburg University Hospital
Study officials:
affiliation: Deutsche Stiftung für chronisch Kranke
name: Bettina Zippel-Schultz, PhD
role: STUDY_DIRECTOR
affiliation: Wuerzburg University Hospital
name: Martin Fassnacht, MD
role: PRINCIPAL_INVESTIGATOR
References: