Implementation of Collaborative Self-management Services to Promote Physical Activity

Chronic Disease Clinical Trial

— NEXTCARE-PA  

Official title:

Protocol for Implementation of Collaborative Self-management Services to Promote Physical Activity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02976064
• Other study ID #: NEXTCARE-PA
• Status: Recruiting
• Phase: N/A
• Start date: April 2016
• Est. completion date: June 2020

Study information

• Verified date: January 2019
• Source: Hospital Clinic of Barcelona
• Contact: Maria Sánchez
• Phone: 34932275747
• Email: masanchezm[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: The growing awareness on the health burden generated by insufficient levels of physical activity has prompted the interest for deploying community-based initiatives aiming at fostering active healthy living. It is of note, however, that, to our knowledge, none of the interventions evaluated so far have reached large scale adoption. The current protocol relies on the general hypothesis that properly tailored self-management programs, fully integrated in the patient's action plan with remote off-line professional support, may induce sustained behavioral changes resulting in exercise health behavior. Accordingly, the current manuscript addresses those unmet requirements, namely: i) Workflow design of the PA services engaging both patients and health professionals; ii) Enhanced information and communication technologies (ICT)-support; iii) Evaluation strategies including structured indicators; and, iv) Implementation of innovative business models. The main outcome of the current protocol will be a roadmap for large scale deployment and assessment of novel collaborative self-management PA services in the region of Catalonia (7.5 million citizens).

Methods: The protocol has been designed as part of the regional deployment of integrated care services in Catalonia (2016-2020). It has been conceived has a two-year (2017-2018) test bed period.

Aims: The protocol uses a population-health approach to addresses the four aims: i) Prehabilitation for high risk candidates to major surgery; ii) Community-based rehabilitation for clinical stable chronic patients with moderate to severe disease; and, iii) Promotion of physical activity and healthy lifestyles for citizens at risk and patients with mild disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. completion date: June 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Arms 1 & 2:

• Candidates to major elective surgical procedures in the following specialties:

abdominal, gynecology, cardiovascular, urology and thoracic

• Patients presenting high surgical risk because they are they are aged > 70 years and/or show an American Society of Anesthesiologist (ASA) score of III/IV

• A tentative surgical schedule allowing for at least 4 weeks for the pre-habilitation intervention.

Arms 3 & 4:

• Patients suffering one or more targeted chronic conditions (cardiovascular diseases, chronic obstructive pulmonary disease and type 2 diabetes mellitus)

• Moderate-to-severe disease (main disorder)

• High user of healthcare resources assessed by history of past hospital-related events (admissions and/or emergency room visits).

Arms 5 & 6:

• Citizens at risk for chronic conditions and patients showing mild target disease(s) recruited through advertisements, primary care centers or pharmacy offices.

Exclusion Criteria:

Arms 1 & 2:

• Emergency surgery

• Unstable cardiac or respiratory disease

• Locomotor limitations precluding the practice of exercise

• Cognitive deterioration impeding the adherence to the program.

Arms 3-6:

• Unstable cardiovascular or respiratory disorders

• Locomotor limitations precluding the practice of exercise

• Cognitive deterioration impeding the adherence to the program.

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Behavioral:
• PreHabilitation
Case identification: Candidates fulfilling the inclusion criteria will be identified by the anesthesiologist. Case evaluation: Candidates will be assessed to identify the overall needs and perform a baseline evaluation. Personalized Work plan definition: Personalization of the plan involves a calendar and planning of face to face visits and remote contacts; intensity of the supervised exercise training program; threshold of steps per day; nutritional intervention; psychological intervention; and integration of the intervention into the overall work plan. Work plan execution & 5-Follow-up+event handling: Involve the follow-up tasks, including non-scheduled interactions through the personal health folder (PHF) 6-Discharge: Patient will be discharged from prehabilitation and moved to rehabilitation.
• Rehabilitation in chronic stable patients in primary care
Case identification: Candidates fulfilling the inclusion criteria will be identified by the general practitioner. Case evaluation: The primary care team will characterize the candidates, covering: i) patient requirements defining the work plan; ii) aerobic capacity and physical activity; iii) identification of factors modulating adherence. Personalized work plan definition: The community-based intervention will include reassessment of the patient's work plan aiming at optimization of both pharmacological and non-pharmacological therapies. Consist of a motivational interview and a physical activity (PA) intervention (6-month duration) based on supervised endurance training, promotion of PA and empowerment for self-management using the PHF. Work plan execution & 5-Follow-up+event handling: The ICT-support will facilitate the program follow up. 6-Discharge: The patient will be discharged or moved to the PA service addressed to citizens at risk & patients with mild disease.
• Rehabilitation in mild chronic patients and citizens at risk
Case identification: Candidates fulfilling the inclusion criteria will be identified by the GP. Case evaluation: i) patient requirements defining the work plan; ii) aerobic capacity and PA; iii) identification of factors modulating adherence. Personalized work plan definition: i) motivational interview; ii) training for the use of the PHF for self-management; and iii) assign one case manager for off-line remote surveillance. The following optional modules are envisaged: i) basic service (above); ii) endurance training programs; iii) community physical activity group sessions; and/or, iv) upgraded PA program including sensors and close off-line supervision. Work plan execution & 5-Follow-up+event handling: The ICT-support will facilitate the program follow up. 6-Discharge: The basic version of the promotion of PA program is conceived for a timeless duration. However, the different modules included in the service portfolio will have specific agendas and associated costs.

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Badalona Serveis Assistencials, Institut de Recerca Biomèdica de Lleida

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications during hospitalization	Primary outcome for arms 1 & 2 - Percentage of patients suffering postoperative complications during hospitalization	Postoperative hospitalization period (up to 90 days)
Primary	Determinants of adoption of the PA service	Primary outcome for arms 3 & 4	Life-span of the project (12 months)
Primary	Changes in Health-related quality of life	Primary outcome for arms 5 & 6 - Short-form 36 survey	Baseline - Six months - 12 months
Secondary	Changes in Aerobic capacity	Six-minute walking test	Baseline - Six months - 12 months
Secondary	Hospital length of stay	Days of hospital stay	Postoperative hospitalization period (up to 90 days)
Secondary	Intensive care unit length of stay	Days of ICU stay	Postoperative hospitalization period (up to 90 days)
Secondary	Changes in Physical activity	Accelerometry	Baseline - Six months - 12 months