Clinical trial NCT04295668: PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home
Official title: PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Surgical Procedure, Unspecified
Keywords: Prehabilitation
Exercise training
Physical activity
Nutrition
Cognitive behavioural therapy
Smoking cessation
eHealth
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prospective sample of risk patients who are candidates for major surgery attended in the outpatient offices of the Hospital Clínic de Barcelona.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative complications
timeFrame: Duration of the initial hospitalization for surgery
measure: Hospital length of stay
timeFrame: Duration of the initial hospitalization for surgery
measure: Severity of postoperative complications
timeFrame: Duration of the initial hospitalization for surgery
Secondary outcomes:
measure: Hospital readmissions at 30 days
timeFrame: From initial hospital discharge to 30 days follow-up
measure: Emergency room visits at 30 days
timeFrame: From initial hospital discharge to 30 days follow-up
measure: Surgical reinterventions at 30 days
timeFrame: From initial hospital discharge to 30 days follow-up
measure: Mortality at 30 days
timeFrame: From initial hospital discharge to 30 days follow-up
Other outcomes:
measure: Six-minute walk test
timeFrame: At program inclusion and at program discharge (on average at 6 weeks)
measure: Physical activity
timeFrame: At program inclusion and at program discharge (on average at 6 weeks)
measure: Psycho-emotional status
timeFrame: At program inclusion and at program discharge (on average at 6 weeks)
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Catalonia
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Josep Roca, Prof
role: STUDY_DIRECTOR
References: