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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— RTQOL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078622
• Other study ID #: 20140101S
• Secondary ID: SH20140101S
• Status: Completed
• Start date: March 2014
• Est. completion date: April 2016

Study information

• Verified date: August 2018
• Source: StratiHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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)

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Respiratory Therapist Education and Case Management
Respiratory Therapists will conduct home care visits over a period of one-year at two-week intervals

Locations

Country	Name	City	State
United States	Isabel Pereira, Md	Carlsbad	California

Sponsors (1)

Lead Sponsor	Collaborator
StratiHealth

Country where clinical trial is conducted

United States, 

Outcome

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