Obesity, Morbid, Patients After Metabolic-bariatric Surgery
Conditions
Keywords
bariatric surgery, patient adherence, post surgery care, morbid obesity, obesity surgery, obesity guide, aftercare program, electronic case file, obesity app, weight loss surgery
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.
Interventions
OTHERearly aftercare
This group begins the aftercare program immediately after their bariatric surgery.
OTHERmid-term to late aftercare
This group begins the aftercare program 18 months post surgery.
Sponsors
Deutsche Stiftung für chronisch Kranke
Deutschen Gesellschaft für Allgemein- und Viszeralchirurgie e.V. (DGAV)
AOK Bayern
Kassenärztliche Vereinigung Bayern
symeda GmbH
AMC Wolfartklinik Gräfelfing
Schön Klinik Nürnberg Fürth
Dr. Lubos Kliniken Bogenhausen
Klinikum Memmingen
Klinikum Passau
Klinikum Nürnberg
Helmholtz Zentrum München
Wuerzburg University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
The study will compare two intervention groups (early intervention and later intervention) to two control groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| - 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 |
| - Single dimensions of the modified King's Score | 18 months | \- Single dimensions of the modified King's Score |
| 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 12 deficiency | 18 months | \- Measurement of Vitamin B 12 (pg/ml); percentage of patients with values below the reference range |
| 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 |
| 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 Patients with iron deficiency | 18 months | \- Measurement of ferritin (µg/l); 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 |
| 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 |
| 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 |
| 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: 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 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 lean Body mass | 18 months | \- Body composition will be assessed by bioelectrical impedance Analysis measuring the percentage of lean Body mass |
| Change in Phase angle | 18 months | \- Body composition will be assessed by bioelectrical impedance Analysis measuring the Phase angle |
| 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) |
| - 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 |
| 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 |
| - 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) |
Countries
Germany
Outcome results
None listed