Adipositas Care & Health Therapy (ACHT)

Wuerzburg University Hospital

Status: Active, not recruiting

Conditions: Patients After Metabolic-bariatric Surgery; Obesity, Morbid

Treatments: Other: early aftercare; Other: mid-term to late aftercare

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04768127

ACHT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 586 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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586 participants in 4 patient groups

Early aftercare (intervention group 1)

Experimental group

Description:

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

Treatment:

Other: early aftercare

Mid-term to long-term aftercare (intervention group 2)

Experimental group

Description:

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.

Treatment:

Other: mid-term to late aftercare

control group 1 (early aftercare)

No Intervention group

Description:

Analogous to intervention group I, patients in this group are invited to the study center after verbal and written information. These patients will attend the one-off evaluation examination (18 months after the operation) at the obesity centre. If interested, patients in this group can be included in intervention group II until the required number of cases (140 patients) has been reached.

control group 2 (mid-term to long-term aftercare)

No Intervention group

Description:

Analogous to intervention group II, patients in this group are invited to the study center after verbal and written information. These patients will attend the one-off evaluation examination at the study center 36 months after the operation.