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PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home

PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04295668
Acronym
PAPRIKA
Enrollment
300
Registered
2020-03-04
Start date
2020-01-01
Completion date
2020-07-30
Last updated
2020-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Surgical Procedure, Unspecified

Keywords

Prehabilitation, Exercise training, Physical activity, Nutrition, Cognitive behavioural therapy, Smoking cessation, eHealth

Brief summary

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.

Interventions

BEHAVIORALUsual 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).

BEHAVIORALPrehabilitation

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.

Sponsors

Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Hospital length of stayDuration of the initial hospitalization for surgeryNumber of days of hospital length of stay during the initial hospitalization for surgery
Postoperative complicationsDuration of the initial hospitalization for surgeryNumber of postoperative complications during the initial hospitalization for surgery
Severity of postoperative complicationsDuration of the initial hospitalization for surgerySeverity of postoperative complications during the initial hospitalization for surgery using the Clavien-Dindo classification

Secondary

MeasureTime frameDescription
Mortality at 30 daysFrom initial hospital discharge to 30 days follow-upNumber of exitus during a 30-day period after surgery
Surgical reinterventions at 30 daysFrom initial hospital discharge to 30 days follow-upNumber of surgical reinterventions during a 30-day period after surgery
Hospital readmissions at 30 daysFrom initial hospital discharge to 30 days follow-upNumber of postoperative complications during a 30-day period after surgery
Emergency room visits at 30 daysFrom initial hospital discharge to 30 days follow-upNumber of emergency room visits during a 30-day period after surgery

Other

MeasureTime frameDescription
Six-minute walk testAt program inclusion and at program discharge (on average at 6 weeks)Distance covered during the six-minute walk test
Psycho-emotional statusAt 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)
Physical activityAt 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)

Countries

Spain

Contacts

Primary ContactAnael Barberan-Garcia, PhD
anaelbg@gmail.com+34 932775540

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026