Adipositas Care & Health Therapy
- Conditions
- Patients After Metabolic-bariatric SurgeryObesity, Morbid
- Interventions
- Other: mid-term to late aftercareOther: early aftercare
- Registration Number
- NCT04768127
- Lead Sponsor
- Wuerzburg University Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 586
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
- State after a revision operation
- Planned two-stage surgical procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mid-term to long-term aftercare (intervention group 2) mid-term to late aftercare Patients in this group first visit the study center 18 months after their bariatric surgery for the initial examination and start the program in month 19 post-op. At the center, they will meet their obesity guide who will set up an electronic case file for the patient and introduce the patient to the obesity app. Throughout the next 18 months, the obesity guide will monitor the patient's therapeutic success and adherence to the therapeutic goals. In month 19 post-surgery, patients visit a sports physician who assesses their mobility and devises a personal training plan. This plan will be uploaded onto the patient's case file and made available to the patient via the app. In months 19,21,24, 30 and 36, patients attend their aftercare appointments at specially trained ACHT physicians, where they will be physically examined and receive tailored dietary advice. In month 36, patients will be reexamined at the study center. Early aftercare (intervention group 1) early aftercare Patients in this group will begin the ACHT program immediately after their bariatric metabolic operation. 3 weeks post surgery, they will attend the initial examination and meet their case manager. The obesity guide will then set up an electronic case file for the patient and introduce the patient to the obesity app. Through the next 18 months the obesity guide will monitor the patient's therapeutic success and adherence to the therapeutic goals. In month 2 patients visit a sports physician who assesses their mobility and physical capacity to compile a personal training plan, which will be uploaded onto the patient's case file and thus be available to the patient via the app. In months 3,6,9.12 and 18, patients will attend their aftercare appointments at specially trained ACHT physicians, where they will be physically examined by a physician and receive tailored dietary advice from a nutritional advisor. In month 18 patients revisit the surgical centre for the follow-up examination
- Primary Outcome Measures
Name Time Method Modified King's Score (comparison between intervention group I and control group I resp. intervention group II and control group II) 18 months 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.
- Secondary Outcome Measures
Name Time Method - Depression 18 months Depression is measured by Patient Health Questionnaire 9 (PHQ-9 questionnaire); Minimum 0 Points, Maximum 27 Points, lower values mean better outcome
Percentage of Patients with iron deficiency 18 months - Measurement of ferritin (µg/l); percentage of patients with values below the reference range
Percentage of Procedure-specific long term complications: gastric ulcers 18 months percentage of patients with gastric ulcers (Patients will be asked for symptoms and findings if endoscopy was performed)
percentage of procedure-specific long term complications: anastomosis Stenosis 18 months percentage of Patients with anastomosis Stenosis (Patients will be asked for recurrent vomiting and if an endoscopic or surgical Intervention was performed)
Change in Phase angle 18 months - Body composition will be assessed by bioelectrical impedance Analysis measuring the Phase angle
Percentage of patients reaching their Treatment Goal for physical activity 18 months 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
General Quality of life 18 months Quality of life is measured by Short Form 36 (SF-36); Minimum 0 Points, Maximum 100 Points; higher values mean a better outcome
Bariatric Quality of life 18 months Quality of life is measured by Bariatric Quality of life (BQL); Minimum 13 Points, Maximum 65 Points; higher values mean a better outcome
Percentage of patients with symptoms of postoperative malnutrition based on 9 standardized questions 18 months - 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"
average number of Sick days 18 months Average number of Sick days in the past 12 months (information provided by the Patient and data of the respective health insurance)
Percentage of Patients with folic acid deficiency 18 months - Measurement of folic acid (ng/ml); percentage of patients with values below the reference range
Percentage of Patients with Vitamin B 6 deficiency 18 months - Measurement of Vitamin B 6 (µg/l); percentage of patients with values below the reference range
Percentage of Procedure-specific long term complications: gall stones 18 months percentage of patients with gall Stones (Patients will receive a sonography of the gall bladder)
Percentage of Procedure-specific long term complications: internal hernia 18 months percentage of patients with internal hernia (Patients are asked if they had surgery for internal hernia)
Percentage of Patients with Vitamin B 1 deficiency 18 months - Measurement of Vitamin B 1 (µg/l); percentage of patients with values below the reference range
Health-specific Quality of life 18 months 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)
- Single dimensions of the modified King's Score 18 months - Single dimensions of the modified King's Score
Percentage of Patients with Vitamin B 12 deficiency 18 months - Measurement of Vitamin B 12 (pg/ml); percentage of patients with values below the reference range
Percentage of Patients with protein deficiency 18 months - Measurement of prealbumin (mg/dl); percentage of patients with values below the reference range
- Acceptance of the ACHT aftercare program 18 months - Acceptance of the ACHT aftercare program by patients and professionals (physicians, nutritionists) measured by a self-designed questionnaire
Percentage of Procedure-specific long term complications: Dumping syndrome 18 months percentage of patients with Dumping syndrome (Patients will be asked for symptoms)
Change in lean Body mass 18 months - Body composition will be assessed by bioelectrical impedance Analysis measuring the percentage of lean Body mass
- Patient adherence 18 months number of attended appointments
Percentage of patients reaching their Goal for steps per day 18 months 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
Trial Locations
- Locations (7)
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, Germany