A pilot trial to analyze the usability, validity and safety of an interventional health app program (Patronus prehab app) for the structured prehabilitation of patients before major surgical interventions: PROTEGO MAXIMA
- Registration Number
- DRKS00026985
- Lead Sponsor
- Goethe-Universität Frankfurt
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 391
Written informed consent
Willing to participate in the particular task I, II, IIIa and IIIb the respective participant has been asked for
Able to understand the survey and scenarios
Patients planned to undergo one of the following surgeries [OPS codes in accordance with the DIMDI OPS version 2021]:
5-070 to 5-073, 5-077 to 5-079 (endocrine glands)
5-32 to 5-43 (lung and bronchus)
5-38 to 5-39 (vascular surgeries without cardiovascular surgery)
5-413 and 5-419 (splenectomy)
5-423 to 5-427 (esophagectomy)
5-434 to 5-438 (gastrectomy)
5-44 (non resecting gastric bypass operations)
5-454 (small bowel resections)
5-455 (large bowel resections)
5-456 (proctocolectomy)
5-484 and 5-485 (rectum resections)
5-502 and 5-503 (anatomical liver resection)
5-512, 5-514.30, 5-515, 5-518.4 and .5 (biliary tract resections)
5-523, 5-524, 5-525, 5-527 and 5-529 (pancreas resections and draining procedures)
5-536 (abdominal wall hernias)
5-553, 5-554, 5-575 to 5-579, 5-604 (urologic resections: kidney, bladder, prostate)
5-652, 5-653, 5-661, 5-683 to 5-687 (gynecologic resections of uterus, ovary, cervix)
5-87 and 5-88 (breast surgery)
and
10 healthy volunteering students (no planned surgery)
and
15 asymptomatic patients with a history of myocardial infarction (no planned surgery)
and
15 patients with a COPD lower than GOLD grade III (no planned surgery)
-Currently pregnant
-Unable to understand the rationale and the aims of the proposed training program
-Unable to interact with the application
-Patients with an ECOG performance status of 4.
-Patients unable to walk, run, step, or cycle.
-Acute myocardial infarction or unstable angina (acute phase) (I20.0, I21)
-Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
-Acute myocarditis or pericarditis (I30, I39, I40)
-Uncontrolled acutely decompensated HF (acute pulmonary edema) (J81)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Define<br>- App-based risk score, Clavien-Dindo-Score<br>- Ratings based on uMARS (Mobile Application Rating Scale), and elements of the ABACUS and the Trustworthiness Checklist, and the App-checklist of the Aktionsbündnis Patientensicherheit e. V.<br>
- Secondary Outcome Measures
Name Time Method Pulse, distance, step-measurement<br>Safety data, especially focusing on cardiovascular and pulmonary events within the exercising program defined with the Karvonen Method<br>Precision of the risk-based approach<br>Alarming and safety scenarios within the intended use<br>