Chronic DiseaseNEXTCARE-PANCT02976064
Implementation of Collaborative Self-management Services to Promote Physical Activity
A study testing PreHabilitation, Rehabilitation in chronic stable patients in primary care and Rehabilitation in mild chronic patients and citizens at risk in people with Chronic Disease, run by Hospital Clinic of Barcelona at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Disease
- What is being tested?
- PreHabilitation, Rehabilitation in chronic stable patients in primary care and Rehabilitation in mild chronic patients and citizens at risk
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,300 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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.
Who cannot join
- 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:
Show all 9Show fewer
- Unstable cardiovascular or respiratory disorders
- Locomotor limitations precluding the practice of exercise
- Cognitive deterioration impeding the adherence to the program.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Anael Barberan Garcia, PhD, +34 932775540, anaelbg@gmail.com
About this study
Official title: Protocol for Implementation of Collaborative Self-management Services to Promote Physical Activity
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
- Being tested
- PreHabilitation, Rehabilitation in chronic stable patients in primary care, Rehabilitation in mild chronic patients and citizens at risk
- Keywords
- physical activity, lifestyle, adaptive case management, telemedicine, integrated care, collaborative self-management
- Medical subject headings
- Chronic Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreHabilitationBehavioural
- 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 careBehavioural
- 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 riskBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| PreHab_Intervention | Experimental | Experimental group of the prehabilitation trial Receives: Behavioral: PreHabilitation |
| PreHab_Control | No intervention | Control group of the prehabilitation trial |
| Chronic patients_Intervention | Experimental | Experimental group of the Rehabilitation in chronic stable patients in primary care trial Receives: Behavioral: Rehabilitation in chronic stable patients in primary care |
| Chronic patients_Control | No intervention | Control group of the Rehabilitation in chronic stable patients in primary care trial |
| Citizens & mild disease_Intervention | Experimental | Experimental group of the Rehabilitation in mild chronic patients and citizens at risk trial Receives: Behavioral: Rehabilitation in mild chronic patients and citizens at risk |
| Citizens & mild disease_Control | No intervention | Control group of the Rehabilitation in mild chronic patients and citizens at risk trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications during hospitalization
Primary outcome for arms 1 \& 2 - Percentage of patients suffering postoperative complications during hospitalization
Measured: Postoperative hospitalization period (up to 90 days)
Determinants of adoption of the PA service
Primary outcome for arms 3 \& 4
Measured: Life-span of the project (12 months)
Changes in Health-related quality of life
Primary outcome for arms 5 \& 6 - Short-form 36 survey
Measured: Baseline - Six months - 12 months
Secondary outcomes (4)
Changes in Aerobic capacity
Six-minute walking test
Measured: Baseline - Six months - 12 months
Hospital length of stay
Days of hospital stay
Measured: Postoperative hospitalization period (up to 90 days)
Intensive care unit length of stay
Days of ICU stay
Measured: Postoperative hospitalization period (up to 90 days)
Changes in Physical activity
Accelerometry
Measured: Baseline - Six months - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2019
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Badalona Serveis Assistencials, Institut de Recerca Biomèdica de Lleida
- Responsible party
- Principal investigator, Josep Roca, Hospital Clinic of Barcelona
- Investigators
- Josep Roca, Prof, Principal investigator, Hospital Clinic de Barcelona - IDIBAPS - University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976064
- Sponsor's protocol ID
- NEXTCARE-PA
- Acronym
- NEXTCARE-PA
- Status last verified
- Jan 2019
- First submitted
- 22 Nov 2016
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30016944
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Implementation of Collaborative Self-management Services to Promote Physical Activity
- ClinicalTrials.gov ID
- NCT02976064
- Acronym / sponsor ID
- NEXTCARE-PA / NEXTCARE-PA
- Conditions
- Chronic Disease
- Keywords
- physical activity, lifestyle, adaptive case management, telemedicine, integrated care, collaborative self-management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Badalona Serveis Assistencials, Institut de Recerca Biomèdica de Lleida
- Study start
- Apr 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jun 2020 (estimated)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PreHab_Intervention | Experimental | Behavioral: PreHabilitationExperimental group of the prehabilitation trial |
| PreHab_Control | No intervention | –Control group of the prehabilitation trial |
| Chronic patients_Intervention | Experimental | Behavioral: Rehabilitation in chronic stable patients in primary careExperimental group of the Rehabilitation in chronic stable patients in primary care trial |
| Chronic patients_Control | No intervention | –Control group of the Rehabilitation in chronic stable patients in primary care trial |
| Citizens & mild disease_Intervention | Experimental | Behavioral: Rehabilitation in mild chronic patients and citizens at riskExperimental group of the Rehabilitation in mild chronic patients and citizens at risk trial |
| Citizens & mild disease_Control | No intervention | –Control group of the Rehabilitation in mild chronic patients and citizens at risk trial |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- 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)
Key exclusion criteria (9 listed)
- Emergency surgery
- Unstable cardiac or respiratory disease
- Locomotor limitations precluding the practice of exercise
- Cognitive deterioration impeding the adherence to the program.
- Unstable cardiovascular or respiratory disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PreHabilitation1. 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. | Behavioural | PreHab_Intervention |
| Rehabilitation in chronic stable patients in primary care1. 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. | Behavioural | Chronic patients_Intervention |
| Rehabilitation in mild chronic patients and citizens at risk1. 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. | Behavioural | Citizens & mild disease_Intervention |
Primary outcome
Postoperative complications during hospitalization
Time frame: Postoperative hospitalization period (up to 90 days)
Primary outcome for arms 1 \& 2 - Percentage of patients suffering postoperative complications during hospitalization
Determinants of adoption of the PA service
Time frame: Life-span of the project (12 months)
Primary outcome for arms 3 \& 4
Changes in Health-related quality of life
Time frame: Baseline - Six months - 12 months
Primary outcome for arms 5 \& 6 - Short-form 36 survey
4 secondary outcomes
Changes in Aerobic capacity
Time frame: Baseline - Six months - 12 months
Hospital length of stay
Time frame: Postoperative hospitalization period (up to 90 days)
Intensive care unit length of stay
Time frame: Postoperative hospitalization period (up to 90 days)
Changes in Physical activity
Time frame: Baseline - Six months - 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Derived from this study: PubMed 30016944Barberan-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Roca, Prof principal investigator
Hospital Clinic de Barcelona - IDIBAPS - University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PreHabilitation, Rehabilitation in chronic stable patients in primary care and Rehabilitation in mild chronic patients and citizens at risk in people with Chronic Disease, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Sánchez (34932275747, masanchezm@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications during hospitalization (time frame: Postoperative hospitalization period (up to 90 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02976064, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.