- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02976064
Implementation of Collaborative Self-management Services to Promote Physical Activity (NEXTCARE-PA)
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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Maria Sánchez
- Telefonnummer: 34932275747
- E-Mail: masanchezm@clinic.cat
Studienorte
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Barcelona, Spanien, 08036
- Rekrutierung
- Hospital Clinic de Barcelona
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Kontakt:
- Anael Barberan Garcia, PhD
- Telefonnummer: +34 932775540
- E-Mail: anaelbg@gmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: PreHab_Intervention
Experimental group of the prehabilitation trial
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6-Discharge: Patient will be discharged from prehabilitation and moved to rehabilitation. |
Kein Eingriff: PreHab_Control
Control group of the prehabilitation trial
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Experimental: Chronic patients_Intervention
Experimental group of the Rehabilitation in chronic stable patients in primary care trial
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6-Discharge: The patient will be discharged or moved to the PA service addressed to citizens at risk & patients with mild disease. |
Kein Eingriff: Chronic patients_Control
Control group of the Rehabilitation in chronic stable patients in primary care trial
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Experimental: Citizens & mild disease_Intervention
Experimental group of the Rehabilitation in mild chronic patients and citizens at risk trial
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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. |
Kein Eingriff: Citizens & mild disease_Control
Control group of the Rehabilitation in mild chronic patients and citizens at risk trial
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Postoperative complications during hospitalization
Zeitfenster: Postoperative hospitalization period (up to 90 days)
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Primary outcome for arms 1 & 2 - Percentage of patients suffering postoperative complications during hospitalization
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Postoperative hospitalization period (up to 90 days)
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Determinants of adoption of the PA service
Zeitfenster: Life-span of the project (12 months)
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Primary outcome for arms 3 & 4
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Life-span of the project (12 months)
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Changes in Health-related quality of life
Zeitfenster: Baseline - Six months - 12 months
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Primary outcome for arms 5 & 6 - Short-form 36 survey
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Baseline - Six months - 12 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Changes in Aerobic capacity
Zeitfenster: Baseline - Six months - 12 months
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Six-minute walking test
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Baseline - Six months - 12 months
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Hospital length of stay
Zeitfenster: Postoperative hospitalization period (up to 90 days)
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Days of hospital stay
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Postoperative hospitalization period (up to 90 days)
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Intensive care unit length of stay
Zeitfenster: Postoperative hospitalization period (up to 90 days)
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Days of ICU stay
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Postoperative hospitalization period (up to 90 days)
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Changes in Physical activity
Zeitfenster: Baseline - Six months - 12 months
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Accelerometry
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Baseline - Six months - 12 months
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Josep Roca, Prof, Hospital Clinic de Barcelona - IDIBAPS - University of Barcelona
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NEXTCARE-PA
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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