PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home

Cancer Clinical Trial

— PAPRIKA  

Official title:

PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04295668
• Other study ID #: HCB/2019/1030
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: July 30, 2020

Study information

• Verified date: March 2020
• Source: Hospital Clinic of Barcelona
• Contact: Anael Barberan-Garcia, PhD
• Phone: +34 932775540
• Email: anaelbg[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Surgical Procedure, Unspecified

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Six-minute walk test	Distance covered during the six-minute walk test	At program inclusion and at program discharge (on average at 6 weeks)
Other	Physical activity	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)
Other	Psycho-emotional status	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)
Primary	Postoperative complications	Number of postoperative complications during the initial hospitalization for surgery	Duration of the initial hospitalization for surgery
Primary	Hospital length of stay	Number of days of hospital length of stay during the initial hospitalization for surgery	Duration of the initial hospitalization for surgery
Primary	Severity of postoperative complications	Severity of postoperative complications during the initial hospitalization for surgery using the Clavien-Dindo classification	Duration of the initial hospitalization for surgery
Secondary	Hospital readmissions at 30 days	Number of postoperative complications during a 30-day period after surgery	From initial hospital discharge to 30 days follow-up
Secondary	Emergency room visits at 30 days	Number of emergency room visits during a 30-day period after surgery	From initial hospital discharge to 30 days follow-up
Secondary	Surgical reinterventions at 30 days	Number of surgical reinterventions during a 30-day period after surgery	From initial hospital discharge to 30 days follow-up
Secondary	Mortality at 30 days	Number of exitus during a 30-day period after surgery	From initial hospital discharge to 30 days follow-up