ACHT - Adipositas Care & Health Therapy Zur Strukturierten, sektorenübergreifenden Versorgung Nach Bariatrisch-metabolischer Operation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 586
- 试验地点
- 14
- 主要终点
- Modified King's Score (comparison between intervention group I and control group I resp. intervention group II and control group II)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •State after a revision operation
- •Planned two-stage surgical procedure
结局指标
主要结局
Modified King's Score (comparison between intervention group I and control group I resp. intervention group II and control group II)
时间窗: 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.
次要结局
- - Depression(18 months)
- Percentage of Procedure-specific long term complications: gastric ulcers(18 months)
- percentage of procedure-specific long term complications: anastomosis Stenosis(18 months)
- Percentage of patients reaching their Treatment Goal for physical activity(18 months)
- General Quality of life(18 months)
- Bariatric Quality of life(18 months)
- average number of Sick days(18 months)
- Percentage of patients with symptoms of postoperative malnutrition based on 9 standardized questions(18 months)
- Percentage of Procedure-specific long term complications: gall stones(18 months)
- Percentage of Procedure-specific long term complications: internal hernia(18 months)
- Percentage of Patients with protein deficiency(18 months)
- Health-specific Quality of life(18 months)
- Percentage of Procedure-specific long term complications: Dumping syndrome(18 months)
- - Patient adherence(18 months)
- Percentage of patients reaching their Goal for steps per day(18 months)
- Percentage of Patients with iron deficiency(18 months)
- Change in lean Body mass(18 months)
- Change in Phase angle(18 months)
- - Acceptance of the ACHT aftercare program(18 months)
- Percentage of Patients with Vitamin B 12 deficiency(18 months)
- Percentage of Patients with Vitamin B 1 deficiency(18 months)
- Percentage of Patients with Vitamin B 6 deficiency(18 months)
- - Single dimensions of the modified King's Score(18 months)
- Percentage of Patients with folic acid deficiency(18 months)
研究者
Martin Fassnacht
Prof. Dr. Martin Fassnacht (Head of Endocrinolgy)
Wuerzburg University Hospital