Implementation of Collaborative Self-management Services to Promote Physical Activity

NCT ID: NCT02976064

Last Updated: 2019-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2020-06-30

Brief 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.

Conditions

Chronic Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

PreHab_Intervention

Experimental group of the prehabilitation trial

Group Type: EXPERIMENTAL

PreHabilitation

Intervention Type: BEHAVIORAL

1. Case identification: Candidates fulfilling the inclusion criteria will be identified by the anesthesiologist.

2. Case evaluation: Candidates will be assessed to identify the overall needs and perform a baseline evaluation.

3. 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.

4. 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.

PreHab_Control

Control group of the prehabilitation trial

Group Type: NO_INTERVENTION

No interventions assigned to this group

Chronic patients_Intervention

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

Group Type: EXPERIMENTAL

Rehabilitation in chronic stable patients in primary care

Intervention Type: BEHAVIORAL

1. Case identification: Candidates fulfilling the inclusion criteria will be identified by the general practitioner.

2. 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.

3. 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.

4. 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.

Chronic patients_Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Citizens & mild disease_Intervention

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

Group Type: EXPERIMENTAL

Rehabilitation in mild chronic patients and citizens at risk

Intervention Type: BEHAVIORAL

1. Case identification: Candidates fulfilling the inclusion criteria will be identified by the GP.

2. Case evaluation: i) patient requirements defining the work plan; ii) aerobic capacity and PA; iii) identification of factors modulating adherence.

3. 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.

4. 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.

Citizens & mild disease_Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PreHabilitation

1. Case identification: Candidates fulfilling the inclusion criteria will be identified by the anesthesiologist.

2. Case evaluation: Candidates will be assessed to identify the overall needs and perform a baseline evaluation.

3. 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.

4. 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.

Intervention Type: BEHAVIORAL

Rehabilitation in chronic stable patients in primary care

1. Case identification: Candidates fulfilling the inclusion criteria will be identified by the general practitioner.

2. 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.

3. 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.

4. 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.

Intervention Type: BEHAVIORAL

Rehabilitation in mild chronic patients and citizens at risk

1. Case identification: Candidates fulfilling the inclusion criteria will be identified by the GP.

2. Case evaluation: i) patient requirements defining the work plan; ii) aerobic capacity and PA; iii) identification of factors modulating adherence.

3. 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.

4. 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Badalona Serveis Assistencials

OTHER

Sponsor Role: collaborator

Institut de Recerca Biomèdica de Lleida

OTHER

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Josep Roca

Consultor senior

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josep Roca, Prof

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic de Barcelona - IDIBAPS - University of Barcelona

Locations

Hospital Clínic de Barcelona

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Maria Sánchez

Role: CONTACT

masanchezm@clinic.cat

34932275747

Facility Contacts

Anael Barberan Garcia, PhD

Role: primary

anaelbg@gmail.com

+34 932775540

References

Barberan-Garcia A, Gimeno-Santos E, Blanco I, Cano I, Martinez-Palli G, Burgos F, Miralles F, Coca M, Murillo S, Sanz M, Steblin A, Ubre M, Benavent J, Vidal J, Sitges M, Roca J. Protocol for regional implementation of collaborative self-management services to promote physical activity. BMC Health Serv Res. 2018 Jul 17;18(1):560. doi: 10.1186/s12913-018-3363-8.

Reference Type: DERIVED

PMID: 30016944 (View on PubMed)

Other Identifiers

NEXTCARE-PA

Identifier Type: -

Identifier Source: org_study_id