CClinicalTrials.gg
CompletedNCT02078622RTQOLUpdated Aug 20, 2018

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

An observational study in Chronic Obstructive Pulmonary Disease (COPD), sponsored by StratiHealth. Completed at 1 site in United States. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-20.

Sponsored by StratiHealth · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
114
Ages
55 Years to 80 Years
Sex
All
01

Study 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)

Read the 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).

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)

Keywords

  • COPD
  • Respiratory Therapist
  • Case Management
  • Education
03

In context

Lung Diseases, Obstructive

2,591 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 114 is below the median of 150 across 638 observational studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

StratiHealth is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who are diagnosed with COPD

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

Exclusion Criteria:

  • Lacks cognitive ability to retain education and training
  • Not managed by primary care physician (family practice)
  • No stable residence or is homeless
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
114 participants (actual)
Target follow-up
24 Weeks
Patient registry
Yes

Groups and cohorts

  • COPD, Education and Case Management

    Respiratory Therapist Education and Case Management

    Other: Respiratory Therapist Education and Case Management

Interventions

  • OtherRespiratory Therapist Education and Case Management

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

06

What researchers measure

Primary outcomes

  1. Quality of Life Using Chronic Respiratory Disease Questionnaire

    Using the CRQ Evaluate Health Outcomes and QOL

    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

Secondary outcomes

  1. Healthcare Utilization

    Hospital Admission, Emergency Room Encounters

    Time frame: 1 year

07

Study locations

1 site
  • Isabel Pereira, Md
    Carlsbad, California 92008, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02078622
Lead sponsor
StratiHealth
Responsible party
Sponsor
First posted
Mar 5, 2014
Start date
Mar 2014
Primary completion
Mar 2016
Completion
Apr 2016
Last update
Aug 20, 2018

Study contacts

ISABEL PEREIRA, MD
principal investigator · StratiHealth
VERNON R PERTELLE, RRT
study director · StratiHealth

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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