- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03942302
Characterization of Variable MARrcha's Diary Variables as a Useful Measure
Characterization of Variable MARrcha's Diary Variables as a Useful Measure of Physical Activity in Patients With Physical COPD in Patients With COPD
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Elisa Simón
- Número de teléfono: 910888877
- Correo electrónico: elisa.simon@bioclever.com
Copia de seguridad de contactos de estudio
- Nombre: Ester Salmerón
- Número de teléfono: 93 2172115
- Correo electrónico: fucapneumo@gmail.com
Ubicaciones de estudio
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Cataluña
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Barcelona, Cataluña, España, 08008
- Reclutamiento
- FUCAP
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Contacto:
- Elisa Simón
- Número de teléfono: 910888877
- Correo electrónico: elisa.simon@bioclever.com
-
Contacto:
- Ester Salmerón
- Número de teléfono: 932172115
- Correo electrónico: fucapneumo@gmail.com
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Investigador principal:
- Francisco Ortega
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Investigador principal:
- Cristina Martínez
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Investigador principal:
- Marc Miravitlles
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Investigador principal:
- Francisco García-Río
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Investigador principal:
- Pilar Carmen Cebollero
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Investigador principal:
- Cristóbal Esteban
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Investigador principal:
- Patricia Sobradillo
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Investigador principal:
- Ernesto Centeno
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Investigador principal:
- María Inés Carrascosa
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Investigador principal:
- Juan José Soler-Cataluña
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
The population under study will be constituted by adult patients diagnosed with COPD.
To avoid selection biases, each participating researcher will include in the study the first 10 patients who come to a pulmonology clinic with a clinical diagnosis of COPD and who meet the selection criteria.
Descripción
Inclusion Criteria:
Adult patients, ≥ 40 years.
- Patients diagnosed with COPD according to the GOLD criteria: FEV1 / FVC postbronchodilator <0.70 in a spirometry performed in the last 12 months.
- Smokers or ex-smokers of ≥10 pack-years.
- Patients with a minimum age in the diagnosis of COPD of at least 6 months.
- Patients who accept their participation in the study and who have given their informed consent (IC) in writing to participate in it.
Exclusion Criteria:
- Patients whose clinical history data are not available.
- Patients unable to understand the study questionnaires.
- Patients with physical limitation (not caused by the respiratory disease, eg disability, orthopedic limitation, etc.) and / or psychic that prevents the proper conduct of the study.
- Patients who present a moderate or severe exacerbation of COPD in the month prior to inclusion.
- Patients with other chronic respiratory diseases other than COPD (such as cystic fibrosis, bronchiectasis of origin other than COPD, neoplasia, pneumonia).
- Patients with serious cardiovascular or neurological diseases.
- Hospital admission for any reason in the month prior to inclusion.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Minutes of daily walking
Periodo de tiempo: During the 7 days that the device has.
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For such effects, the level of physical activity will be determined through a unique question, formulated in 5 different ways, which aims to collect the minutes of physical activity or daily walking minutes. The one that best fits the objective of the study will be selected. The questions that will be asked will be:
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During the 7 days that the device has.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Date of inclusion in the study
Periodo de tiempo: day 9
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[day-month-year]
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day 9
|
Age
Periodo de tiempo: day 9
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[date of birth, day-month-year]
|
day 9
|
Sex
Periodo de tiempo: day 9
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[male / female]
|
day 9
|
Size
Periodo de tiempo: day 9
|
[cm]
|
day 9
|
Weight
Periodo de tiempo: day 9
|
[kg]
|
day 9
|
Body Mass Index
Periodo de tiempo: day 9
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(BMI) [kg / m2]
|
day 9
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Marital Status
Periodo de tiempo: day 9
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[single / married / separated / divorced / widowed]
|
day 9
|
Family situation
Periodo de tiempo: day 9
|
Coexistence situation [only (a) / accompanied)
|
day 9
|
Place of residence
Periodo de tiempo: day 9
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[house / flat / others, specify]
|
day 9
|
Academic training
Periodo de tiempo: day 9
|
[without studies, primary, secondary, university studies]
|
day 9
|
Employment status
Periodo de tiempo: day 9
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[self-employed / self-employed / unemployed / retired (a) / household tasks / other, specify]
|
day 9
|
Socioeconomic level
Periodo de tiempo: day 9
|
family income 15000€/15000€-25000€/25000€-30000€/>30000€
|
day 9
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Smoking
Periodo de tiempo: day 9
|
[yes / ex]
|
day 9
|
Date
Periodo de tiempo: day 9
|
[day-month-year]
|
day 9
|
Description of instruments and measures
Periodo de tiempo: day 9
|
Spirometry is a test of lung function (flow and capacity) that evaluates the amount of air through exhalation. The forced spirometry, in particular, is based on making the patient after a maximum inspiration exhale all the air, in the shortest time possible. [forced expiratory volume the first second (FEV1) in milliliters / forced vital capacity (FVC) in milliliters / FEV1 / FVC ratio (FEV1%) |
day 9
|
FEV1
Periodo de tiempo: day 9
|
it is a measure of flow and is expressed in milliliters and is the maximum volume exhaled in the first second of a forced expiration.
Its normal value is> 80% of the theoretical value.
|
day 9
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FVC
Periodo de tiempo: day 9
|
it is a measurement of capacity that is expressed in milliliters and is the maximum volume of exhaled air with the maximum possible effort, based on the total volume that the patient expels from maximum inspiration to maximum expiration.
Its normal value is> 80% of the theoretical value.
|
day 9
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FEV1%
Periodo de tiempo: day 9
|
it is indicative of the percentage of the total volume expired during the first second.
Its normal value is> 70-75% of the theoretical value.
|
day 9
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Phenotype of COPD
Periodo de tiempo: day 9
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[non-exacerbator / mixed COPD-asthma / exacerbation with emphysema /exacerbator with chronic bronchitis]
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day 9
|
Non-pharmacological treatment
Periodo de tiempo: day 9
|
[smoking cessation / rehabilitation program / oxygen therapy / others, specify]
|
day 9
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Number and scope of treatment of exacerbations suffered in the last year
Periodo de tiempo: day 9
|
[ambulatory / hospital]
|
day 9
|
Date of the last moderate-severe exacerbation.
Periodo de tiempo: day 9
|
[day-month-year]
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day 9
|
Scales, questionnaires and indexes
Periodo de tiempo: day 9
|
|
day 9
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Spirometry
Periodo de tiempo: day 9
|
|
day 9
|
BODE and BODEX Index (Annex 8)
Periodo de tiempo: day 9
|
|
day 9
|
COTE comorbidity index (annex 9)
Periodo de tiempo: day 9
|
The COTE index (Divo et al., 2012) describes 10 comorbidities: cancer (lung, esophagus, pancreas and breast) (6 points), other cancers (2 points), anxiety (in women, 6 points), liver cirrhosis (2 points), atrial fibrillation (2 points), diabetes with neuropathy (2 points), pulmonary fibrosis (2 points), congestive heart failure (1 point), gastroduodenal ulcer (1 point) and coronary disease (1 point) (range) 0-25).
A score ≥ 4 increases more than 2 times the expected risk of death.
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day 9
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Charlson comorbidity index (InCC) (Annex 10)
Periodo de tiempo: day 9
|
The Charlson comorbidity index (Charlson et al., 1987) is a 10-year survival assessment system, depending on the age of the patient being evaluated and the comorbidities of the subject.
In addition to age, it consists of 19 items, which if present, have been found to influence the patient's life expectancy.
Each item has a weight in the index, which can be 1, 2, 3 and 6.
The age ranges are also scored from 0 to 5.
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day 9
|
HADS questionnaire (Annex 11)
Periodo de tiempo: day 9
|
It is a scale that evaluates patients' anxiety and depression status (Zigmond & Snaith, 1983).
One of its main attractions is that it suppresses somatic symptoms so that it can be evaluated independently of the underlying somatic disease.
It consists of 14 items on a Likert scale of 4 points (range 0 - 3) to assess anxiety and depression (7 items for each).
The total score is the sum of the 14 items (range 0 - 42), and for each subscale the score is the sum of the 7 items (range 0 - 21).
It is considered that between 0 and 7 it does not indicate case, between 8 and 10 it would be a doubtful case and the scores superior to 11 are, probably, cases in each one of the subscales.
|
day 9
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CAT Scale (Annex 12)
Periodo de tiempo: day 9
|
The CAT scale (Jones et al., 2009) measures the impact that COPD is having on the well-being and daily life of patients.
It consists of 8 items (cough, sputum, tightness in the chest, shortness of breath climbing slopes / stairs, limitation of activity in the home, confidence to leave home, sleep and energy).
Each item is valued on a scale of 6 points with different formats semantically (from 0 to 5), with a total score from 0 to 40.
A score between 0-10 would be indicative of a low impact of the disease.
|
day 9
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Modified MRC scale (Annex 13)
Periodo de tiempo: day 9
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The modified MRC scale (Mahler & Wells, 1988) uses a very simple grading system to obtain the degree of dyspnea of the patient.
This scale does not define the sensation of drowning per se, but it shows the degree of alteration that said drowning exerts on a day-to-day basis.
It consists of 5 degrees of physical activity that provokes dyspnea that ranges from 0 (no type of exercise is capable of inducing dyspnea) and 4 (dyspnea prevents the patient from leaving the house or doing activities such as dressing or grooming).
A higher score would be indicative of a greater degree of functional limitation.
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day 9
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PROactive questionnaire (Annex 14)
Periodo de tiempo: day 9
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This questionnaire about physical activity is a hybrid tool that combines results perceived by patients (PRO) and given physical activity objectives that come from the accelerometer (Gimeno-Santos et al., 2015).
The version for clinical visit (Clinical visit PROactive PRO) will be used, which gathers the experiences of physical activity of the patients in the last 7 days.
It consists of 12 questions and 2 variables of the accelerometer (14 items in total), with options on a Likert scale of 0 to 4 points, and with a score that ranges between 0 and 56 points.
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day 9
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Accelerometer (Annex 15)
Periodo de tiempo: from day 2 to 8
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The accelerometer is a motion sensor that uses a pinzoelectric transducer to detect acceleration movements in any of the 3 space dimensions (antero-posterior, medial-lateral, and longitudinal).
Continuous monitoring of the actual physical activity of each patient will be obtained through a triaxial accelerometer (Dynaport® MoveMonitor) for a week.
The accelerometer will be placed on all participants on the day of the IC signature.
The device will be programmed to start the measurement on the day following V0 (day 2).
The patient will be instructed to carry the device 24 hours a day for the next 7 days (day 2-8).
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from day 2 to 8
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Proof of the march (PM6M) (Annex 16)
Periodo de tiempo: day 9
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It is a physical activity test to evaluate the effort capacity, being very simple and easy to perform, with the use of very little equipment (Holland et al., 2014, Singh et al., 2014).
In this case, the maximum distance in meters that the patient travels in 6 minutes will be evaluated.
Due to the learning factor demonstrated in this test, 2 tests will be carried out and the test in which the patient reached the greatest distance will be taken into account in the analysis.
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day 9
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Questionnaire on motivation to perform physical activity.
Periodo de tiempo: day 9
|
This is the translation into Spanish of the questionnaire developed by Danilack et al, 2014 It consists of 4 domains (motivation, confidence, physical environment and social support) For the general reasons of motivation and trust, the subjects were asked: In general, how motivated are you to walk every day?
And How confident do you feel you can walk every day? with responses on a Likert scale from 1 to 10, where the highest scores reflect greater motivation and confidence.
In addition, motivation and confidence were characterized to evaluate the reasons for walking and the confidence to exercise in different situations, including health reasons, bad weather, low energy, lack of time and fear of injury.
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day 9
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Ferran Morell, Fundacio Catalana de Pneumologia
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FUC-EPO-2018-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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