PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home

NCT04295668 | Unknown

• 1 other identifier: HCB/2019/1030
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Surgical Procedure, Unspecified

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Postoperative complications

  Number of postoperative complications during the initial hospitalization for surgery

  Duration of the initial hospitalization for surgery

• 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

• 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 Outcomes (4)

• Hospital readmissions at 30 days

  From initial hospital discharge to 30 days follow-up

• Emergency room visits at 30 days

  From initial hospital discharge to 30 days follow-up

• Surgical reinterventions at 30 days

  From initial hospital discharge to 30 days follow-up

• Mortality at 30 days

  From initial hospital discharge to 30 days follow-up

Other Outcomes (3)

• Six-minute walk test

  At program inclusion and at program discharge (on average at 6 weeks)

• Physical activity

  At program inclusion and at program discharge (on average at 6 weeks)

• Psycho-emotional status

  At program inclusion and at program discharge (on average at 6 weeks)

Study Arms (2)

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.

Behavioral: Usual care

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.

Behavioral: Prehabilitation

Interventions

Usual care BEHAVIORAL

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).

Usual care

Prehabilitation BEHAVIORAL

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.

Prehabilitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age \> 70 years old and/or American Society of Anesthesiologist (ASA) index 3-4 and/or highly aggressive surgery or solid organ transplantation.

You may not qualify if:

• Non-elective surgery; metastatic disease.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Catalonia, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasms; Motor Activity; Smoking Cessation

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Josep Roca, Prof

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

Central Study Contacts

Anael Barberan-Garcia, PhD

CONTACT

+34 932775540; anaelbg@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 4, 2020
• Study Start: January 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: July 30, 2020
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

ES (1)