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Patient Empowerment for Major Surgery Preparation @ Home (Paprika)

Primary Purpose

Urologic Diseases, Cardiovascular Diseases, Thoracic Diseases

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

multimodal prehabilitation

About this trial

This is an interventional prevention trial for Urologic Diseases

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Centre Hospitalier Universitaire Grenoble AlpesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Paprika group

Historical group

Arm Description

Patients coming for elective major surgery will participate to Paprika program

Patients previously operated with same characteristics

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number and severity of postoperative complications

Number and severity of postoperative complications using Dindo-Clavien classification within 30 days

Length of stay (ICU and Hospital)

Length of ICU stay and Length of hospital stay

Hospital readmission

Hospital readmission within 30 days

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

Physical activity health status

Health status based on physical activity score:GPAQ and DASI scores

Nutritional health status

Nutritional health status based on weight, appetite and ingesta measurements

Psychological health status

Psychological health status based on HAD, Perceived Stress Scale scores

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

Ratio patient participation to each session

Ratio patient participation to each session to assess faisability and limitation to participation

Comparison with other centers

Comparison will be done with other cohorts using Paprika program (Barcelona, Gdansk and Köln) on common outcomes

Full Information

NCT ID

NCT04190719

First Posted

December 3, 2019

Last Updated

April 29, 2021

Sponsor

University Hospital, Grenoble

Collaborators

EIT Health, Hospital Clinic of Barcelona, Universitätsklinikum Köln, University Clinical Centre, Gdansk

1. Study Identification

Unique Protocol Identification Number

NCT04190719

Brief Title

Patient Empowerment for Major Surgery Preparation @ Home

Acronym

Paprika

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 3, 2020 (Actual)

Primary Completion Date

September 30, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Grenoble

Collaborators

EIT Health, Hospital Clinic of Barcelona, Universitätsklinikum Köln, University Clinical Centre, Gdansk

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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

Detailed 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urologic Diseases, Cardiovascular Diseases, Thoracic Diseases, Orthopedic Disorder, Gastrointestinal Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Interventional group: Patients with Paprika program Historical group: Patients with same characteristics operated in 2018-2019

Masking

None (Open Label)

Masking Description

Paprika program will be proposed to all eligible patients.

Allocation

Non-Randomized

Enrollment

225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Paprika group

Arm Type

Experimental

Arm Description

Patients coming for elective major surgery will participate to Paprika program

Arm Title

Historical group

Arm Type

No Intervention

Arm Description

Patients previously operated with same characteristics

Intervention Type

Other

Intervention Name(s)

multimodal prehabilitation

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of postoperative complications at Day-30

Description

Rate of postoperative complications at Day-30 classified following the standards of the European Society of Anaesthesiology and European Society of intensive Care Medicine.

Time Frame

at Day-30 post surgery

Secondary Outcome Measure Information:

Title

Number and severity of postoperative complications

Description

Number and severity of postoperative complications using Dindo-Clavien classification within 30 days

Time Frame

within 30 days post surgery

Title

Length of stay (ICU and Hospital)

Description

Length of ICU stay and Length of hospital stay

Time Frame

within 30 days post surgery

Title

Hospital readmission

Description

Hospital readmission within 30 days

Time Frame

within 30 days post surgery

Title

Direct cost

Description

Time Frame

interventional group: 1 month-cost before surgery+1 month-post surgery / Control group: 1 month-cost post-surgery

Title

Physical activity health status

Description

Health status based on physical activity score:GPAQ and DASI scores

Time Frame

a baseline, presurgery and 6 months post surgery

Title

Nutritional health status

Description

Nutritional health status based on weight, appetite and ingesta measurements

Time Frame

at baseline, 1 month and 6 months

Title

Psychological health status

Description

Psychological health status based on HAD, Perceived Stress Scale scores

Time Frame

at baseline, 1 month and 6 months

Title

Number of patient participation to program in relation to the number of eligible patients

Description

Number of patient participation to program in relation to the number of eligible patients to assess faisability

Time Frame

During Paprika inclusion period

Title

Ratio patient participation to each session

Description

Ratio patient participation to each session to assess faisability and limitation to participation

Time Frame

During Paprika 1 month-sessions

Title

Comparison with other centers

Description

Comparison will be done with other cohorts using Paprika program (Barcelona, Gdansk and Köln) on common outcomes

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marie-France Vaillant

Phone

+33 4 76 76 89 13

mfvaillant@chu-grenoble.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Laura Albaladejo

EXT-LAlbaladejo@chu-grenoble.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre Albaladejo, Prof.

Organizational Affiliation

CHU Grenoble Alpes

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Universitaire Grenoble Alpes

City

La Tronche

ZIP/Postal Code

38700

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marie-France Vaillant

Phone

+33 4 76 76 89 13

mfvaillant@chu-grenoble.fr

First Name & Middle Initial & Last Name & Degree

Laura Albaladejo

EXT-LAlbaladejo@chu-grenoble.fr

First Name & Middle Initial & Last Name & Degree

Pierre Albaladejo

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymised data will be shared with Barcelona, Köln and Gdansk: all collected IPD

IPD Sharing Time Frame

Data will be available at the end of the study: starting July 2021

IPD Sharing Access Criteria

IPD will be shared with other sites in order to compare results coming from common questionnaires and data. Statistical analyses will be performed for Grenoble site separately and pooled with the other sites in a second step.

Citations:

PubMed Identifier

28489682

Citation

Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.

Results Reference

result

PubMed Identifier

31248644

Citation

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: secondary results from a randomised controlled trial. Br J Anaesth. 2019 Oct;123(4):450-456. doi: 10.1016/j.bja.2019.05.032. Epub 2019 Jun 25.

Results Reference

result

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Patient Empowerment for Major Surgery Preparation @ Home

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