Condition or disease |
---|
Chronic Obstructive Pulmonary Disease |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 10 participants |
Observational Model: | Other |
Time Perspective: | Other |
Target Follow-Up Duration: | 9 Months |
Official Title: | Characterization of Variable MARrcha's Diary Variables as a Useful Measure of Physical Activity in Patients With Physical COPD in Patients With COPD |
Actual Study Start Date : | March 1, 2019 |
Estimated Primary Completion Date : | December 1, 2019 |
Estimated Study Completion Date : | April 1, 2020 |
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:
Coexistence situation [only (a) / accompanied)
[yes / ex]
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%)
Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Adult patients, ≥ 40 years.
Exclusion Criteria:
Contact: Elisa Simón | 910888877 | elisa.simon@bioclever.com | |
Contact: Ester Salmerón | 93 2172115 | fucapneumo@gmail.com |
Spain | |
FUCAP | Recruiting |
Barcelona, Cataluña, Spain, 08008 | |
Contact: Ester Salmerón 932172115 fucapneumo@gmail.com | |
Contact: Elisa Simón 910888877 elisa.simon@bioclever.com | |
Principal Investigator: Francisco Ortega | |
Principal Investigator: Cristina Martínez | |
Principal Investigator: Marc Miravitlles | |
Principal Investigator: Francisco García-Río | |
Principal Investigator: Pilar Carmen Cebollero | |
Principal Investigator: Cristóbal Esteban | |
Principal Investigator: Patricia Sobradillo | |
Principal Investigator: Ernesto Centeno | |
Principal Investigator: María Inés Carrascosa | |
Principal Investigator: Juan José Soler-Cataluña |
Study Director: | Ferran Morell | Fundacio Catalana de Pneumologia |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date | April 15, 2019 | ||||
First Posted Date | May 8, 2019 | ||||
Last Update Posted Date | May 8, 2019 | ||||
Actual Study Start Date | March 1, 2019 | ||||
Estimated Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Minutes of daily walking [ Time Frame: During the 7 days that the device has. ] 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:
|
||||
Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
|
||||
Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Characterization of Variable MARrcha's Diary Variables as a Useful Measure | ||||
Official Title | Characterization of Variable MARrcha's Diary Variables as a Useful Measure of Physical Activity in Patients With Physical COPD in Patients With COPD | ||||
Brief Summary | Validate a simple clinical tool to evaluate physical activity (the question "How many minutes does it walk per day?" Or equivalent), compared to the rest of the collected physical activity data (PROactive questionnaire and objective physical activity data by means of an accelerometer record) in patients with COPD. | ||||
Detailed Description | Observational, national and multicenter epidemiological study in adult patients with COPD that will take place in the consultations of specialists in pneumology under conditions of usual clinical practice and that will be developed in two visits per patient. | ||||
Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Other Time Perspective: Other |
||||
Target Follow-Up Duration | 9 Months | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population |
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. |
||||
Condition | Chronic Obstructive Pulmonary Disease | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
10 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | April 1, 2020 | ||||
Estimated Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria: Adult patients, ≥ 40 years.
Exclusion Criteria:
|
||||
Sex/Gender |
|
||||
Ages | 40 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Spain | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03942302 | ||||
Other Study ID Numbers | FUC-EPO-2018-01 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement |
|
||||
Responsible Party | Ferran Morell, Fundacio Catalana de Pneumologia | ||||
Study Sponsor | Ferran Morell | ||||
Collaborators | Not Provided | ||||
Investigators |
|
||||
PRS Account | Fundacio Catalana de Pneumologia | ||||
Verification Date | May 2019 |