The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 3)
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 45 - 80 |
| Updated: | 1/6/2019 |
| Start Date: | September 17, 2018 |
| End Date: | July 1, 2021 |
| Contact: | Fernando J Martinez, MD, MS |
| Email: | fjm2003@med.cornell.edu |
| Phone: | 646-962-2748 |
The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care
A prospective, multicenter study including a cross-section validation to define sensitivity
and specificity of CAPTURE to identify previously undiagnosed patients with clinically
significant Chronic Obstructive Pulmonary Disease (COPD), and its impact on clinical care
across a broad range of primary care settings in a cluster randomized controlled clinical
trial.
and specificity of CAPTURE to identify previously undiagnosed patients with clinically
significant Chronic Obstructive Pulmonary Disease (COPD), and its impact on clinical care
across a broad range of primary care settings in a cluster randomized controlled clinical
trial.
This is a large prospective, multi-center study explore the impact of the CAPTURE tool on
clinical care and patient outcomes across a broad range of primary care settings in a cluster
randomized controlled clinical trial.
The CAPTURE tool consists of a 5-item self-administered questionnaire and selected use of
peak expiratory flow (PEF) measurement, designed to identify clinically significant COPD.
The study will enroll approximately 5,000 patients across 100 participating primary care
clinics associated with practice-based research networks (PBRNs). Participants will be
assessed with the CAPTURE Tool and have research spirometry testing.
Participating primary care practices will be randomized in a 1:1 fashion to one of the
following interventions:
- Arm 1: Practice clinicians will receive basic COPD education, and patient-level CAPTURE
information with CAPTURE interpretation education (CAPTURE+ COPD education).
- Arm 2: Practice clinicians will receive basic COPD education only (COPD education) and
will be blinded to patient-level CAPTURE information.
A predefined subgroup of participants will undergo longitudinal follow-up at 12 months to
determine the impact of the CAPTURE Tool on clinical care and patient outcomes. Participant
reported data will be collected through in-person visits, telephone and mail-based
methodologies, depending upon practice site preferences and feasibility. Clinic site data
will also be collected from the medical record to assess for changes in practice-level care.
clinical care and patient outcomes across a broad range of primary care settings in a cluster
randomized controlled clinical trial.
The CAPTURE tool consists of a 5-item self-administered questionnaire and selected use of
peak expiratory flow (PEF) measurement, designed to identify clinically significant COPD.
The study will enroll approximately 5,000 patients across 100 participating primary care
clinics associated with practice-based research networks (PBRNs). Participants will be
assessed with the CAPTURE Tool and have research spirometry testing.
Participating primary care practices will be randomized in a 1:1 fashion to one of the
following interventions:
- Arm 1: Practice clinicians will receive basic COPD education, and patient-level CAPTURE
information with CAPTURE interpretation education (CAPTURE+ COPD education).
- Arm 2: Practice clinicians will receive basic COPD education only (COPD education) and
will be blinded to patient-level CAPTURE information.
A predefined subgroup of participants will undergo longitudinal follow-up at 12 months to
determine the impact of the CAPTURE Tool on clinical care and patient outcomes. Participant
reported data will be collected through in-person visits, telephone and mail-based
methodologies, depending upon practice site preferences and feasibility. Clinic site data
will also be collected from the medical record to assess for changes in practice-level care.
Inclusion Criteria:
- 1. Provision of signed and dated informed consent form
- 2. Stated willingness to comply with all study procedures and availability for the
duration of the study
- 3. Male or female, aged 45 - 80 years
Exclusion Criteria:
- 1. Previous clinician provided diagnosis of COPD
- 2. Treated respiratory infection (with antibiotics and/or systemic steroids) in the
past 30 days
- 3. Participants unable to perform spirometry due to any of the following conditions
within the past 30 days
1. Chest surgery
2. Abdominal surgery
3. Eye surgery
4. Heart attack
5. Stroke
We found this trial at
6
sites
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
Phone: 503-494-0361
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