Patient Empowerment for Major Surgery Preparation @ Home

Cardiovascular Diseases Clinical Trial

— Paprika  

Official title:

Patient Empowerment for Major Surgery Preparation @ Home: Multimodal Prehabilitation in Major Elective Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04190719
• Other study ID #: 38RC19.182
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2020
• Source: University Hospital, Grenoble
• Contact: Marie-France Vaillant
• Phone: +33 4 76 76 89 13
• Email: mfvaillant[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Non-randomized monocentric open cohort study vs historical comparative group testing the efficacy of a multimodal prehabilitation program (based on physical activity, nutritional support and mental preparation) for unfit patients based on nutrition, physical activity and mental preparation in reducing postoperative complications in elective major surgery

Description:

Prehabilitation programs essentially based on physical activity improvement may reduce postoperative complications after major surgery. We hypothesize that a multimodal program based on physical activity, nutritional support and mental preparation may not only improve postoperative recovery and reduce costs but also improve health status beyond postoperative period.

Non-randomized monocentric open cohort study vs historical comparative group testing the efficacy of a multimodal prehabilitation program for unfit patients based on nutrition, physical activity and mental preparation in reducing postoperative complications in elective major surgery.

Other outcomes will be measured : length of hospital stay, hospital readmissions, direct costs, health status at 1 and 6 months.

Moreover, the feasibility and adherence of Paprika program will be evaluated. Inter-data centres relating to the implementation of the same prehabilitation program will be compared with the consortium Paprika (Hospital Clinic of Barcelona, University of Cologne, University of Gdansk)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patient eligible to elective major surgery (digestive, orthopedic, vascular-thoracic, urologic)

• Age > 70 years and/or American Society of Anesthesiologists (ASA) score 3-4

• or Unfit patient according to appropriate scores (Two among 3 scores (HAD, Physical activity score, nutritional score) below threshold). Unfit patients will be defined by at least 2 criteria if 'YES' answers: Physical activity: Less than 50% of WHO recommendations = less than 5000 steps/day or less than 75 min moderate activity/week or less than 12 min moderate activity/day Yes/No Malnutrition: BMI < 20 kg/m2 if < 70 years (or <22 if >70y) = undernutrition Yes/No or BMI>25 kg/m2 (= overweight to obesity) or Loss of appetite? Mental evaluation HAD (Hospital Anxiety and Depression) >8 for A or D score Yes/No

• Diagnosis:

Elective major surgery (digestive, orthopedic, vascular-thoracic, urologic)

• Regulatory aspects: Be legally able to give consent Patient affiliated to social security

Exclusion Criteria:

• Planned surgery (less than 4 weeks at inclusion)

• Urgent surgery

• Patient with, at baseline, good to excellent physical, nutritional, mental status as defined by appropriate scores.

• Patient considered not eligible to this program for physical or psychological reasons by the surgeon or the anesthetist

• Persons referred in Articles L1121-5 to L1121-8 of the French code of public health (this corresponds to all persons protected: pregnant or parturient women, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure).

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Musculoskeletal Diseases
• Orthopedic Disorder
• Thoracic Diseases
• Urologic Diseases

Intervention

Other:
• multimodal prehabilitation
Paprika prehabilitation program content: patients will have choices for each activity. Messages and motivation will be reinforced by using a mobile app or leaflet advices, according to patient's preferences. Physical activity promotion by discovering ebike, personalised gymnastics and encouragement to increase the number of daily steps of patients, measured by a wristband and a mobile App An individualized nutritional optimization plan with dietary advices and protein supplementation (if necessary). Psychological support will be proposed through auto-hypnosis sensibilisation or management of stress with Cognitive Behavior Stress Management technics

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Grenoble Alpes	La Tronche

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Grenoble	EIT Health, Hospital Clinic of Barcelona, Universitätsklinikum Köln, University Clinical Centre, Gdansk

Country where clinical trial is conducted

France, 

References & Publications (2)

Barberan-Garcia A, Ubre M, Pascual-Argente N, Risco R, Faner J, Balust J, Lacy AM, Puig-Junoy J, Roca J, Martinez-Palli G. Post-discharge impact and cost-consequence analysis of prehabilitation in high-risk patients undergoing major abdominal surgery: sec — View Citation

Barberan-Garcia A, Ubré M, Roca J, Lacy AM, Burgos F, Risco R, Momblán D, Balust J, Blanco I, Martínez-Pallí G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of postoperative complications at Day-30	Rate of postoperative complications at Day-30 classified following the standards of the European Society of Anaesthesiology and European Society of intensive Care Medicine.	at Day-30 post surgery
Secondary	Number and severity of postoperative complications	Number and severity of postoperative complications using Dindo-Clavien classification within 30 days	within 30 days post surgery
Secondary	Length of stay (ICU and Hospital)	Length of ICU stay and Length of hospital stay	within 30 days post surgery
Secondary	Hospital readmission	Hospital readmission within 30 days	within 30 days post surgery
Secondary	Direct cost	Valuation in euros of the direct cost from a 1-month hospital point of view (duration and type of stay, acts, GHM...) by integrating for the intervention group the cost of the pre-habilitation program. Care consumption at 6 months from a social security perspective (Probabilistic Matching National Health Data System)--> comparison of direct costs for the Prehab sessions (professional caregivers and materials costs) versus complication costs of control group	interventional group: 1 month-cost before surgery+1 month-post surgery / Control group: 1 month-cost post-surgery
Secondary	Physical activity health status	Health status based on physical activity score:GPAQ and DASI scores	a baseline, presurgery and 6 months post surgery
Secondary	Nutritional health status	Nutritional health status based on weight, appetite and ingesta measurements	at baseline, 1 month and 6 months
Secondary	Psychological health status	Psychological health status based on HAD, Perceived Stress Scale scores	at baseline, 1 month and 6 months
Secondary	Number of patient participation to program in relation to the number of eligible patients	Number of patient participation to program in relation to the number of eligible patients to assess faisability	During Paprika inclusion period
Secondary	Ratio patient participation to each session	Ratio patient participation to each session to assess faisability and limitation to participation	During Paprika 1 month-sessions
Secondary	Comparison with other centers	Comparison will be done with other cohorts using Paprika program (Barcelona, Gdansk and Köln) on common outcomes	through study completion, an average of 1 year