Implementation of Collaborative Self-management Services to Promote Physical Activity (NEXTCARE-PA)

Hospital Clinic of Barcelona

Status: Unknown

Conditions: Chronic Disease

Treatments: Behavioral: Rehabilitation in mild chronic patients and citizens at risk; Behavioral: Rehabilitation in chronic stable patients in primary care; Behavioral: PreHabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT02976064

NEXTCARE-PA

Details and patient eligibility

About

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.

Enrollment: 2,300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,300 participants in 6 patient groups

PreHab_Intervention

Experimental group

Description:

Experimental group of the prehabilitation trial

Treatment:

Behavioral: PreHabilitation

PreHab_Control

No Intervention group

Description:

Control group of the prehabilitation trial

Chronic patients_Intervention

Experimental group

Description:

Experimental group of the Rehabilitation in chronic stable patients in primary care trial

Treatment:

Behavioral: Rehabilitation in chronic stable patients in primary care

Chronic patients_Control

No Intervention group

Description:

Control group of the Rehabilitation in chronic stable patients in primary care trial

Citizens & mild disease_Intervention

Experimental group

Description:

Experimental group of the Rehabilitation in mild chronic patients and citizens at risk trial

Treatment:

Behavioral: Rehabilitation in mild chronic patients and citizens at risk

Citizens & mild disease_Control

No Intervention group

Description:

Control group of the Rehabilitation in mild chronic patients and citizens at risk trial