Effectiveness of Standardized Respiratory Physiotherapy in Primary Care (FREAP) (FREAP)
Effectiveness of Standardized Respiratory Physiotherapy in Primary Care in Patients With Mild COPD and Its Economic Assessment
Chronic Obstructive Pulmonary Disease (COPD) is a very important public health problem and one of the most common lung diseases in the world, with repercussions on mortality and high economic costs. The World Health Organization estimates that COPD is the fifth most common disease in the world and the fourth leading cause of death. It is expected to grow in prevalence and mortality over the coming decades; it is estimated that in 2020, it will be the third most common cause of death worldwide.
Primary care is the main ambit in the management of these patients, in fact, it is where most patients with COPD are visited. However, a high proportion of these patients only receive chest physiotherapy treatment in hospitals, and the implementation of this kind of treatment in primary care is still very uncommon.
Hypothesis: There is effectiveness on the quality of life and various predictive factors of mortality (BODE index, six-minute walk distance, FEV1, dyspnea, and body mass index) and the economic impact of a Standardized Respiratory Physiotherapy program conducted in Primary Care (FREAP) in patients with moderate COPD at 6 months after its implementation.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
AIMS
To evaluate the effectiveness on the quality of life and various predictive factors of mortality (BODE index, six-minute walk distance, FEV1, dyspnea, and body mass index) and the economic impact of a Standardized Respiratory Physiotherapy program conducted in Primary Care (FREAP) in patients with moderate COPD at 6 months after its implementation.
METHOD
Design: Randomized controlled trial
Location: Tarragona-Reus Primary Care Area of the Catalan Health Service. 14 primary care centres were involved in the project (8 from the Reus-Altebrat Primary Care Service and 6 from the Tarragona-Valls Primary Care Service) and 8 units of physiotherapy.
Participants: 129 patients with moderate COPD treated by primary care teams.
Intervention: FREAP program for 6 months. It consisted of an initial health education session conducted in the primary care health centre, three sessions a week for three weeks of breathing exercises and aerobic, physical training in the primary care health centre and a monthly monitoring appointment for the breathing exercises and training for five months in the patient's home. Altogether, 10 sessions in the primary care health center and 5 sessions at the patients' house. Patients randomized in the control group continued with their usual clinical practice.
Main effect measures: Quality of life (St. George Respiratory Questionnaire -SGRQ-). Predictive factors of mortality (BODE index, six-minute walk distance, FEV1, dyspnea, and body mass index). Economic cost of implementing the FREAP program.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Tarragona
-
Reus, Tarragona, Spanien, 43202
- Catalan Health Institute
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Mild COPD diagnostic by GOLD criteria.
- Absence of contraindications for walk tests and training.
- Disponibility.
- Age between 40 and 74 years old.
Exclusion Criteria:
- Patients with treatment of oxygen or domiciliary oxygen therapy.
- Communication deficience(dementia, terminal illness, illiteracy).
- Informed consent not available.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Standardized Respiratory Physiotherapy
Standardized Respiratory Physiotherapy is the intervention in all selected patients. It consisted of an initial health education session conducted in the primary care health centre, three sessions a week for three weeks of breathing exercises and aerobic, physical training in the primary care health centre and a monthly monitoring appointment for the breathing exercises and training for five months in the patient's home. Altogether, 10 sessions in the primary care health center and 5 sessions at the patients' house. |
Standardized Respiratory Physiotherapy during 6 months
|
|
Placebo-Komparator: Placebo
Usual clinical practice.
|
Usual clinical practice.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
St-George Respiratory Questionnaire-SGRQ
Zeitfenster: Six months
|
The questionnaire is designed to measure the impact of respiratory symptoms and their treatment on a patient's daily life. It consists of various sections that cover a range of topics related to respiratory health, including symptoms, activity limitations, and overall well-being. The SGRQ questionnaire has 50 items with 76 weighted responses. Scores range from 0 to 100, with higher scores indicating more limitations. |
Six months
|
|
BODE Index
Zeitfenster: 6 month
|
The BODE index is a clinical tool used to assess the severity of chronic obstructive pulmonary disease (COPD) and predict the risk of mortality in individuals with this respiratory condition. The BODE Index is a 0 to 10-point scale and it is based on four factors:
Each factor is assigned a score from 0 to 3 (except for BMI, which can only receive 0 or 1). The total score ranges from 0 to 10, with higher values indicating greater severity and a worse prognosis for COPD. |
6 month
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
BODE index
Zeitfenster: Six months
|
Is a complex index that measures dyspnea, FEV1, BMI, and six-minute walk distance
|
Six months
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Maria Montserrat Ingles Novell, Catalan Institute of Health
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Geschätzt)
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
- P07/42
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