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

NCT ID: NCT02078622

Last Updated: 2018-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-04-30

Brief Summary

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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

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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).

Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD, Education and Case Management

Respiratory Therapist Education and Case Management

Respiratory Therapist Education and Case Management

Intervention Type OTHER

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

Interventions

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Respiratory Therapist Education and Case Management

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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StratiHealth

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ISABEL PEREIRA, MD

Role: PRINCIPAL_INVESTIGATOR

StratiHealth

VERNON R PERTELLE, RRT

Role: STUDY_DIRECTOR

StratiHealth

Locations

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Isabel Pereira, Md

Carlsbad, California, United States

Site Status

Countries

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United States

Other Identifiers

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SH20140101S

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20140101S

Identifier Type: -

Identifier Source: org_study_id

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