Included are patients with elecitve colorectal surgery, most common reasons: Bowel/Sigma/Rectum Carcinoma
Conditions
Interventions
Group 1: technical instructions + daily ERAS-SOC (standard of care) + consultations with motivational interviewing (1x preoperative (+-20min) and 4x postoperative (one time per day after surgery, +-15
Sponsors
Universitätsklinikum Mannheim
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • patients with elective bowel surgery • adults (=18 years) • agreement for therapy according to ERAS criteria • ability to understand the character and the individual consequences of the study. Also the acceptance and willingness to follow the requirements of the study protocol (carrying sensors, photo-documentation) • signed declaration of consent after study instructions • Barthel Index concerning mobility at least 10 points: "walks with help of one person (verbal or physical) > 50 yards"
Exclusion criteria
Exclusion criteria: • language barriers (valid declaration of consent is not possible, misunderstanding of the documentation) • hearing problems, which can not be compensated and make a fluent conversation difficult • mental conditions, which make a MI-consultation impossible • confinement to bed (Barthel mobility < 10 points) • PEG or parenteral nutrition • expected non-compliance • cardial devices: CCM, ICD, CRT, because of the interaction risk with mobility-sensors • participation on another study with the same primary endpoint (mobility or nutrition)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the groups as to whether motivational interviewing can improve the achievement of the ERAS-goals with regard to postoperative mobilization and nutrition (from op day to third postoperative day) Mobilization parameter: Steps & activity parameters: lie, sit, stand, walk Nutrition parameter: Kcal Uptake via food & proteinshakes | — |
Secondary
| Measure | Time frame |
|---|---|
| „Scientific-Feasibility“: Evaluation of the postoperative food-intake and mobilization in general with objective data exploration meaningfullness of „universelly“ (not-personalized) ERAS-goals Validity and Fidelity of the MI-Intervention (Patient perspective: REM-Questionnaire; Supervision (qualitative) and objective, quantiative Evaluation with Motivational Interviewing Treatment Integrity - MITI); “contamination” of the control group (quantitative by written questioning after the study, if they think that they were in the control or experimental group - examination of blinding; REM - Questionnaire; „Process-Feasibility“: recruitment-rate (percentage included participants after screening); acceptance und compliance of the patients in terms of technical equipment (percentage utilization of the sensors & photo-documentation); evaluation of the MI-Consulations by patients (Rating Scales for the Assessment of Empathic Communication in Medical Interviews - REM-questionnaire); integration MI-intervention in everyday life of the clinic (quantitative: Duration of MI-Consultations; qualitative: clinic-setting, interviewer-perspective) Questionnaires: IPAQ - physical activity (pre-op) PG-SGA - nutrition (pre-op) GSE - Self-efficacy (pre-op, post op day 3) PAM13-D - Patientactivation (pre-op, post op day 3) PEQ - Patient-Satisfaction (post-op day 30) HADS - Anxiety/Depression (pre-op, post op day 3) QoR-15 - Quality of Recovery (pre-op, post op day 1 & 3) Barthel-Index (pre-op, post op day 3) REM - felt empathy (post-op day 3) further raised parameters: ERAS-Compliance Variables (EIAS - database) apparative with sensors: kcal-consumption, MET-Level, heartfrequency, HRV (Baevskii-Stress-Index) daily pain, nausea (NRS-scale) op-duration, duration of hospitalization subjective assessment (patients) concerncing activity and food-intake for comparison with objective data usage of MI-elements from self-created "guide" (checked by supervision) for | — |
Countries
Germany
Contacts
Public ContactFlorian Herrle
Medizinische Fakultät Mannheim der Universität Heidelberg Chirurgische Klinik Universitätsmedizin Mannheim
Outcome results
None listed