PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home
NCT ID: NCT04295668
Last Updated: 2020-03-04
Study Results
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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UNKNOWN
300 participants
OBSERVATIONAL
2020-01-01
2020-07-30
Brief Summary
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It is at the first stage aimed to high-risk patients undergoing major surgery. Better condition before the surgery is proved to reduce the perioperative complications and to improve patients' health-related quality of life while cutting the associated costs. The concept integrates short-term (average 4 weeks) preoperative interventions including endurance training, promotion of physical activity and nutritional and psychological support. Interventions are planned both at community and at hospital reducing unnecessary interactions between patients and tertiary care.
PAPRIKA tackles three major drivers: i) human perspective ii) organizational challenges and iii) technical aspects. The project is based on previous experience on prehabilitation and the already refined service using design thinking methodologies. It will be also based on the proven reduction of associated costs for the healthcare system.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Usual care
A contemporaneous control group of patients was build using propensity score matching (PSM) methodologies taking into account the following matching variables: type of surgery, age, sex, American Society of Anesthesiologists Index (ASA) and adjusted morbidity groups (GMA) grading.
Usual care
The preoperative standard measures consist of physical activity recommendation and advice on both smoking cessation and alcohol intake reduction. Moreover, in patients presenting with anemia, the anesthesiologists will assess its etiology and treat it accordingly, and nutritional intervention will be performed by a registered dietitian in to those patients at risk of malnutrition (Malnutrition Universal Screening Tool ≥2).
Prehabilitation
Prospective sample of risk patients who are candidates for major surgery attended in the outpatient offices of the Hospital Clínic de Barcelona.
Inclusion criteria: i) American Society of Anesthesiologists Index (ASA) 3-4; and / or, ii) age ≥ 75 years; and / or iii) major aggressive surgery; and, iv) solid organ transplant candidate.
Exclusion criteria: i) Non-elective surgery; ii) Known metastatic disease before surgery; iii) Unstable respiratory or heart disease; or, iv) Locomotive or cognitive limitations that prevent adherence to the program.
Prehabilitation
i) Exercise training: Ambulatory exercise training sessions with two main components, namely: high-intensity endurance exercise training and strength muscular training.
ii) Promotion of physical activity: Pedometer-based program using a physical activity tracker linked to a mobile app.
iv) Nutritional optimization: Recommendations of a healthy balanced diet or adapted to their digestive symptoms. Daily amount of protein intake will be close to 2 g•Kg-1•day-1.
iv) Smoking cessation: Use of both cognitive behavioral intervention and pharmacological therapy by varenicline or nicotine replacement therapies.
v) Cognitive behavioral therapy: Weekly group sessions conducted by a clinical health psychologist, including psychoeducation, motivational and behavioral change, self-efficacy and adherence enhancement, coping strategies acquisition and patient empowerment.
Interventions
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Usual care
The preoperative standard measures consist of physical activity recommendation and advice on both smoking cessation and alcohol intake reduction. Moreover, in patients presenting with anemia, the anesthesiologists will assess its etiology and treat it accordingly, and nutritional intervention will be performed by a registered dietitian in to those patients at risk of malnutrition (Malnutrition Universal Screening Tool ≥2).
Prehabilitation
i) Exercise training: Ambulatory exercise training sessions with two main components, namely: high-intensity endurance exercise training and strength muscular training.
ii) Promotion of physical activity: Pedometer-based program using a physical activity tracker linked to a mobile app.
iv) Nutritional optimization: Recommendations of a healthy balanced diet or adapted to their digestive symptoms. Daily amount of protein intake will be close to 2 g•Kg-1•day-1.
iv) Smoking cessation: Use of both cognitive behavioral intervention and pharmacological therapy by varenicline or nicotine replacement therapies.
v) Cognitive behavioral therapy: Weekly group sessions conducted by a clinical health psychologist, including psychoeducation, motivational and behavioral change, self-efficacy and adherence enhancement, coping strategies acquisition and patient empowerment.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
Responsible Party
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Anael Barberan-Garcia
Principal investigator
Principal Investigators
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Josep Roca, Prof
Role: STUDY_DIRECTOR
Hospital Clinic of Barcelona
Locations
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Hospital Clínic de Barcelona
Barcelona, Catalonia, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HCB/2019/1030
Identifier Type: -
Identifier Source: org_study_id
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