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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Other: Respiratory Therapist Education and Case Management

• Registration Number: NCT02078622
• Lead Sponsor: 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)

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-01
• Study First Submitted QC: 2014-03-03
• Study First Posted: 2014-03-05
• Primary Completion: 2016-03
• Study Completion: 2016-04
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD, Education and Case Management	Respiratory Therapist Education and Case Management	Respiratory Therapist Education and Case Management

Primary Outcome Measures

Name	Time	Method
Quality of Life Using Chronic Respiratory Disease Questionnaire	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

Name	Time	Method
Healthcare Utilization	1 year	Hospital Admission, Emergency Room Encounters

Trial Locations

Locations (1)

Isabel Pereira, Md; 🇺🇸 Carlsbad, California, United States