Adipositas Care & Health Therapy

N/AActive Not RecruitingNCT04768127

Wuerzburg University Hospital586 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

586

Conditions

Patients After Metabolic-bariatric Surgery Obesity, Morbid

Interventions

early aftercareOTHER

This group begins the aftercare program immediately after their bariatric surgery.

mid-term to late aftercareOTHER

This group begins the aftercare program 18 months post surgery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Nuremberg, Germany

Outcomes

Primary Outcomes

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.

Time frame: 18 months

Secondary Outcomes

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

Time frame: 18 months

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

Time frame: 18 months

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)

Time frame: 18 months

- Depression

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

- Single dimensions of the modified King's Score

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.