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AzTrials

Urologic DiseasesPaprikaNCT04190719

Patient Empowerment for Major Surgery Preparation @ Home

A study testing multimodal prehabilitation in people with Urologic Diseases and Cardiovascular Diseases, run by University Hospital, Grenoble at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
multimodal prehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
225 participants
Where
1 siteFrance
Study dates
3 Jan 2020to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Marie-France Vaillant contact

+33 4 76 76 89 13

mfvaillant@chu-grenoble.fr

Laura Albaladejo contact

EXT-LAlbaladejo@chu-grenoble.fr

France1 site, 1 recruiting

  • Centre Hospitalier Universitaire Grenoble Alpes

    La Tronche, 38700

    Marie-France Vaillant, +33 4 76 76 89 13, mfvaillant@chu-grenoble.fr

    Laura Albaladejo, EXT-LAlbaladejo@chu-grenoble.fr

    Recruiting

Other trials in France

About this study

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

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

Read the 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)

Being tested
multimodal prehabilitation
Medical subject headings
Urologic Diseases, Cardiovascular Diseases, Thoracic Diseases, Musculoskeletal Diseases, Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • multimodal prehabilitationOther

    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
Study groups in NCT04190719
Study groupRoleWhat they receive
Paprika groupExperimentalPatients coming for elective major surgery will participate to Paprika program
Receives: Other: multimodal prehabilitation
Historical groupNo interventionPatients previously operated with same characteristics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at Day-30 post surgery

Secondary outcomes (10)

  1. Number and severity of postoperative complications

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

    Measured: within 30 days post surgery

  2. Length of stay (ICU and Hospital)

    Length of ICU stay and Length of hospital stay

    Measured: within 30 days post surgery

  3. Hospital readmission

    Hospital readmission within 30 days

    Measured: within 30 days post surgery

  4. 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

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

  5. Physical activity health status

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

    Measured: a baseline, presurgery and 6 months post surgery

  6. Nutritional health status

    Nutritional health status based on weight, appetite and ingesta measurements

    Measured: at baseline, 1 month and 6 months

  7. Psychological health status

    Psychological health status based on HAD, Perceived Stress Scale scores

    Measured: at baseline, 1 month and 6 months

  8. 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

    Measured: During Paprika inclusion period

  9. Ratio patient participation to each session

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

    Measured: During Paprika 1 month-sessions

  10. Comparison with other centers

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

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2019
  2. Study start3 Jan 2020
  3. Primary completion30 Sep 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Interventional group: Patients with Paprika program Historical group: Patients with same characteristics operated in 2018-2019
Masking
None (open label)
Enrolment
225 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04190719
Sponsor's protocol ID
38RC19.182
Acronym
Paprika
Status last verified
Nov 2020
First submitted
3 Dec 2019
Last updated
30 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymised data will be shared with Barcelona, Köln and Gdansk: all collected IPD

Publications

  • 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.

    PubMed 28489682

  • 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.

    PubMed 31248644

Questions about this trial

What is this clinical trial studying?

A study testing multimodal prehabilitation in people with Urologic Diseases and Cardiovascular Diseases, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marie-France Vaillant (+33 4 76 76 89 13, mfvaillant@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of postoperative complications at Day-30 (time frame: at Day-30 post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04190719, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.

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