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OpenTrials
Completed

NCT Number: NCT02078622

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

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)

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Isabel Pereira, Md

Carlsbad, California, 92008, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory Therapist Education and Case Management

Other

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

Primary outcomes

  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 outcomes

  1. Healthcare Utilization

    Time frame: 1 year

    Hospital Admission, Emergency Room Encounters

Sponsors and collaborators

Lead sponsor

StratiHealth

Industry

Registry information

Official study 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

Acronym: RTQOL

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 5, 2014
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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