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

NCT02078622 | Completed DMC

• 2 other identifiers: 20140101SSH20140101S
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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)

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Respiratory Therapist; Case Management; Education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Healthcare Utilization

  1 year

Study Arms (1)

COPD, Education and Case Management

Respiratory Therapist Education and Case Management

Other: Respiratory Therapist Education and Case Management

Interventions

Respiratory Therapist Education and Case Management OTHER

Respiratory Therapists will conduct home care visits over a period of one-year at two-week intervals

COPD, Education and Case Management

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are diagnosed with COPD

You may qualify if:

• 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)

You may not qualify if:

• Lacks cognitive ability to retain education and training
• Not managed by primary care physician (family practice)
• No stable residence or is homeless

Sponsors & Collaborators

• StratiHealth: lead

Study Sites (1)

Isabel Pereira, Md

Carlsbad, California, 92008, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Case Management

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• ISABEL PEREIRA, MD

  StratiHealth

  PRINCIPAL INVESTIGATOR

• VERNON R PERTELLE, RRT

  StratiHealth

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2014
• First Posted: March 5, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

US (1)