early aftercare
OtherThis group begins the aftercare program immediately after their bariatric surgery.
NCT Number: NCT04768127
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
AMC WolfartKlinik, Zentrum für Adipositas- und Metabolische Chirurgie, Gräfelfing, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
relevant for all groups:
group specific criteria:
Intervention group I ("early aftercare"):
Intervention Group II ("medium-term and late after care") recruited from control group I:
Control group I (compared to early intervention):
Control group II (compared to late intervention):
Exclusion criteria
This group begins the aftercare program immediately after their bariatric surgery.
This group begins the aftercare program 18 months post surgery.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 18 months
Depression is measured by Patient Health Questionnaire 9 (PHQ-9 questionnaire); Minimum 0 Points, Maximum 27 Points, lower values mean better outcome
Time frame: 18 months
Time frame: 18 months
Time frame: 18 months
Time frame: 18 months
Time frame: 18 months
Time frame: 18 months
Time frame: 18 months
Time frame: 18 months
Time frame: 18 months
percentage of patients with Dumping syndrome (Patients will be asked for symptoms)
Time frame: 18 months
percentage of patients with gastric ulcers (Patients will be asked for symptoms and findings if endoscopy was performed)
Time frame: 18 months
percentage of patients with gall Stones (Patients will receive a sonography of the gall bladder)
Time frame: 18 months
percentage of patients with internal hernia (Patients are asked if they had surgery for internal hernia)
Time frame: 18 months
percentage of Patients with anastomosis Stenosis (Patients will be asked for recurrent vomiting and if an endoscopic or surgical Intervention was performed)
Time frame: 18 months
Time frame: 18 months
Time frame: 18 months
Average number of Sick days in the past 12 months (information provided by the Patient and data of the respective health insurance)
Time frame: 18 months
number of attended appointments
Time frame: 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
Time frame: 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
Time frame: 18 months
Wuerzburg University Hospital
Other
ACHT - Adipositas Care & Health Therapy Zur Strukturierten, sektorenübergreifenden Versorgung Nach Bariatrisch-metabolischer Operation
Acronym: ACHT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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