Patient Empowerment for Major Surgery Preparation @ Home

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-03

Study Completion Date

2021-12-31

Brief Summary

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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

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Detailed Description

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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)

Conditions

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Urologic Diseases Cardiovascular Diseases Thoracic Diseases Orthopedic Disorder Gastrointestinal Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Paprika program will be proposed to all eligible patients.

Study Groups

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Paprika group

Patients coming for elective major surgery will participate to Paprika program

Group Type EXPERIMENTAL

multimodal prehabilitation

Intervention Type OTHER

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

Historical group

Patients previously operated with same characteristics

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No