Adipositas Care & Health Therapy

Obesity, Morbid Clinical Trial

— ACHT  

Official title:

ACHT - Adipositas Care & Health Therapy Zur Strukturierten, sektorenübergreifenden Versorgung Nach Bariatrisch-metabolischer Operation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04768127
• Other study ID #: ACHT
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2024
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 586
• Est. completion date: May 31, 2024
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid
• Patients After Metabolic-bariatric Surgery

Intervention

Other:
• early aftercare
This group begins the aftercare program immediately after their bariatric surgery.
• mid-term to late aftercare
This group begins the aftercare program 18 months post surgery.

Locations

Country	Name	City	State
Germany	AMC WolfartKlinik, Zentrum für Adipositas- und Metabolische Chirurgie	Gräfelfing
Germany	Adipositaszentrum Klinikum Memmingen	Memmingen
Germany	Chirurgische Klinik München-Bogenhausen GmbH	München
Germany	Klinikum Nürberg	Nürnberg
Germany	Sana Klinikum Offenbach GmbH	Offenbach
Germany	Klinikum Passau	Passau
Germany	Wuerzburg University Hospital	Wuerzburg

Sponsors (13)

Lead Sponsor	Collaborator
Wuerzburg University Hospital	AMC Wolfartklinik Gräfelfing, AOK Bayern, Deutsche Stiftung für chronisch Kranke, Deutschen Gesellschaft für Allgemein- und Viszeralchirurgie e.V. (DGAV), Dr. Lubos Kliniken Bogenhausen, Helmholtz Zentrum München, Kassenärztliche Vereinigung Bayern, Klinikum Memmingen, Klinikum Nürnberg, Klinikum Passau, Schön Klinik Nürnberg Fürth, symeda GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified King's Score (comparison between intervention group I and control group I resp. intervention group II and control group II)	Primary endpoint will be the difference in the modified King's Score between intervention group I and control group I resp. intervention group II and control group II. The modified King's Score is a multifaceted sum score taking into account categories A to L (airways, BMI, cardiovascular, diabetes mellitus, economic, functional, gonadal/sexuality, health status, body image, junction (gastroesophageal), kidney, liver). For each category patients receive between 0 and 3 points describing the degree of impairment (0 Points: normal; 3 Points: severe impairment); the minimum score can be 0, maximum sum score can thus be 36.	18 months
Secondary	General Quality of life	Quality of life is measured by Short Form 36 (SF-36); Minimum 0 Points, Maximum 100 Points; higher values mean a better outcome	18 months
Secondary	Bariatric Quality of life	Quality of life is measured by Bariatric Quality of life (BQL); Minimum 13 Points, Maximum 65 Points; higher values mean a better outcome	18 months
Secondary	Health-specific Quality of life	Quality of life is measured by EuroQuol-5 dimensions (EQ-5D); each of the 5 dimensions has between 1 Point (no Limitation in that Dimension) and 5 Points (severe Limitation in that Dimension)	18 months
Secondary	- Depression	Depression is measured by Patient Health Questionnaire 9 (PHQ-9 questionnaire); Minimum 0 Points, Maximum 27 Points, lower values mean better outcome	18 months
Secondary	- Single dimensions of the modified King's Score	- Single dimensions of the modified King's Score	18 months
Secondary	Percentage of Patients with folic acid deficiency	- Measurement of folic acid (ng/ml); percentage of patients with values below the reference range	18 months
Secondary	Percentage of Patients with Vitamin B 12 deficiency	- Measurement of Vitamin B 12 (pg/ml); percentage of patients with values below the reference range	18 months
Secondary	Percentage of Patients with Vitamin B 1 deficiency	- Measurement of Vitamin B 1 (µg/l); percentage of patients with values below the reference range	18 months
Secondary	Percentage of Patients with Vitamin B 6 deficiency	- Measurement of Vitamin B 6 (µg/l); percentage of patients with values below the reference range	18 months
Secondary	Percentage of Patients with iron deficiency	- Measurement of ferritin (µg/l); percentage of patients with values below the reference range	18 months
Secondary	Percentage of Patients with protein deficiency	- Measurement of prealbumin (mg/dl); percentage of patients with values below the reference range	18 months
Secondary	Percentage of patients with symptoms of postoperative malnutrition based on 9 standardized questions	- Postoperative nutritional status will be assessed via 9 questions from a standardized questionnaire (StuDoQ DGAV); questions can be answered by "yes" or "no"; number of questions answered by "yes"	18 months
Secondary	Percentage of Procedure-specific long term complications: Dumping syndrome	percentage of patients with Dumping syndrome (Patients will be asked for symptoms)	18 months
Secondary	Percentage of Procedure-specific long term complications: gastric ulcers	percentage of patients with gastric ulcers (Patients will be asked for symptoms and findings if endoscopy was performed)	18 months
Secondary	Percentage of Procedure-specific long term complications: gall stones	percentage of patients with gall Stones (Patients will receive a sonography of the gall bladder)	18 months
Secondary	Percentage of Procedure-specific long term complications: internal hernia	percentage of patients with internal hernia (Patients are asked if they had surgery for internal hernia)	18 months
Secondary	percentage of procedure-specific long term complications: anastomosis Stenosis	percentage of Patients with anastomosis Stenosis (Patients will be asked for recurrent vomiting and if an endoscopic or surgical Intervention was performed)	18 months
Secondary	Change in lean Body mass	- Body composition will be assessed by bioelectrical impedance Analysis measuring the percentage of lean Body mass	18 months
Secondary	Change in Phase angle	- Body composition will be assessed by bioelectrical impedance Analysis measuring the Phase angle	18 months
Secondary	average number of Sick days	Average number of Sick days in the past 12 months (information provided by the Patient and data of the respective health insurance)	18 months
Secondary	- Patient adherence	number of attended appointments	18 months
Secondary	Percentage of patients reaching their Goal for steps per day	Percentage of Patients achieving their treatment goal for steps per day, comparison between individual goal (defined according to the physical working capacity 120) and state at study inclusion	18 months
Secondary	Percentage of patients reaching their Treatment Goal for physical activity	Percentage of Patients achieving their treatment goal for physical activity, comparison between individual goal (defined according to the physical working capacity 120) and state at study inclusion	18 months
Secondary	- Acceptance of the ACHT aftercare program	- Acceptance of the ACHT aftercare program by patients and professionals (physicians, nutritionists) measured by a self-designed questionnaire	18 months