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Use of Respiratory Therapists (RTs) to Improve Outcomes and Quality of Life in Patients With COPD (RTQOL)

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ClinicalTrials.gov Identifier: NCT02078622
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
StratiHealth

Brief Summary:

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)


Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease (COPD) Other: Respiratory Therapist Education and Case Management

Detailed Description:
Evaluate subjects in an prospective randomized controlled trial in which subjects will be screened and administered scientifically validated questionnaires at study entry and during the observation period at specified intervals 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, utilizing the Chronic Respiratory Disease Questionnaire (CRQ). The secondary endpoints will be rate of exacerbation's and health care utilization (emergency room encounters, hospital admissions).

Study Type : Observational [Patient Registry]
Actual Enrollment : 114 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Weeks
Official 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
Study Start Date : March 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Group/Cohort Intervention/treatment
COPD, Education and Case Management
Respiratory Therapist Education and Case Management
Other: Respiratory Therapist Education and Case Management
Respiratory Therapists will conduct home care visits over a period of one-year at two-week intervals




Primary Outcome Measures :
  1. Quality of Life Using Chronic Respiratory Disease Questionnaire [ Time Frame: 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 ]
    Using the CRQ Evaluate Health Outcomes and QOL


Secondary Outcome Measures :
  1. Healthcare Utilization [ Time Frame: 1 year ]
    Hospital Admission, Emergency Room Encounters



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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who are diagnosed with COPD
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078622


Locations
United States, California
Isabel Pereira, Md
Carlsbad, California, United States, 92008
Sponsors and Collaborators
StratiHealth
Investigators
Principal Investigator: ISABEL PEREIRA, MD StratiHealth
Study Director: VERNON R PERTELLE, RRT StratiHealth

Responsible Party: StratiHealth
ClinicalTrials.gov Identifier: NCT02078622     History of Changes
Other Study ID Numbers: 20140101S
SH20140101S ( Other Grant/Funding Number: STRATIHEALTH )
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018

Keywords provided by StratiHealth:
COPD
Respiratory Therapist
Case Management
Education

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases