Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— RTQOLOfficial title:
A Prospective Randomized Controlled Trial to Evaluate the Use of Respiratory Therapists (RTs) to Improve Outcomes and Quality of Life in Patients Diagnosed With COPD
NCT number | NCT02078622 |
Other study ID # | 20140101S |
Secondary ID | SH20140101S |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2014 |
Est. completion date | April 2016 |
Verified date | August 2018 |
Source | StratiHealth |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Evaluate subjects in an prospective randomized controlled trial in which subjects will be
administered scientifically validated questionnaires to determine the effect of the education
and case management by Respiratory Therapists (RTs) on improvements in: health outcomes and
quality of life as primary endpoints
Utilize: Chronic Respiratory Disease Questionnaire (CRQ)
The secondary endpoints will be: Rate of exacerbation's, Health care utilization (emergency
room encounters, hospital admissions)
Status | Completed |
Enrollment | 114 |
Est. completion date | April 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of COPD - Cognitive ability to retain education and training - Resides in a stable residence or home, apartment - Managed by primary care physician (family practice) Exclusion Criteria: - Lacks cognitive ability to retain education and training - Not managed by primary care physician (family practice) - No stable residence or is homeless |
Country | Name | City | State |
---|---|---|---|
United States | Isabel Pereira, Md | Carlsbad | California |
Lead Sponsor | Collaborator |
---|---|
StratiHealth |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of Life Using Chronic Respiratory Disease Questionnaire | Using the CRQ Evaluate Health Outcomes and QOL | Measure Dyspnea at baseline upon study entry and change from baseline every two weeks up to three months; Numerical, 7-point modified Likert Scale; Total score and subscores on categories; higher scores indicate better health-related quality of life | |
Secondary | Healthcare Utilization | Hospital Admission, Emergency Room Encounters | 1 year |
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