- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04295668
PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home (PAPRIKA)
PAPRIKA establishes a technologically enabled and personalized prehabilitation and follow-up after surgical intervention program for patients undergoing elective major surgery Program creates close collaboration between the medical environment and the patients empowering them to co-create their own care.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Catalonia
-
Barcelona, Catalonia, Spain, 08036
- Recruiting
- Hospital Clínic de Barcelona
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 70 years old and/or American Society of Anesthesiologist (ASA) index 3-4 and/or highly aggressive surgery or solid organ transplantation.
Exclusion Criteria:
- Non-elective surgery; metastatic disease.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative complications
Time Frame: Duration of the initial hospitalization for surgery
|
Number of postoperative complications during the initial hospitalization for surgery
|
Duration of the initial hospitalization for surgery
|
Hospital length of stay
Time Frame: Duration of the initial hospitalization for surgery
|
Number of days of hospital length of stay during the initial hospitalization for surgery
|
Duration of the initial hospitalization for surgery
|
Severity of postoperative complications
Time Frame: Duration of the initial hospitalization for surgery
|
Severity of postoperative complications during the initial hospitalization for surgery using the Clavien-Dindo classification
|
Duration of the initial hospitalization for surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital readmissions at 30 days
Time Frame: From initial hospital discharge to 30 days follow-up
|
Number of postoperative complications during a 30-day period after surgery
|
From initial hospital discharge to 30 days follow-up
|
Emergency room visits at 30 days
Time Frame: From initial hospital discharge to 30 days follow-up
|
Number of emergency room visits during a 30-day period after surgery
|
From initial hospital discharge to 30 days follow-up
|
Surgical reinterventions at 30 days
Time Frame: From initial hospital discharge to 30 days follow-up
|
Number of surgical reinterventions during a 30-day period after surgery
|
From initial hospital discharge to 30 days follow-up
|
Mortality at 30 days
Time Frame: From initial hospital discharge to 30 days follow-up
|
Number of exitus during a 30-day period after surgery
|
From initial hospital discharge to 30 days follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Six-minute walk test
Time Frame: At program inclusion and at program discharge (on average at 6 weeks)
|
Distance covered during the six-minute walk test
|
At program inclusion and at program discharge (on average at 6 weeks)
|
Physical activity
Time Frame: At program inclusion and at program discharge (on average at 6 weeks)
|
Physical activity measured by the Yale Physical Activity Survey (YPAS) (range 0 to 142; the lowest the worst)
|
At program inclusion and at program discharge (on average at 6 weeks)
|
Psycho-emotional status
Time Frame: At program inclusion and at program discharge (on average at 6 weeks)
|
Psycho-emotional status measured by the Hospital Anxiety and Depression (HAD) scale (range 0-21; the highest the worst)
|
At program inclusion and at program discharge (on average at 6 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Josep Roca, Prof, Hospital Clinic of Barcelona
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HCB/2019/1030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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