Use of Respiratory Therapists (RTs) to Improve Outcomes a... | NCT02078622

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

NCT02078622

Sponsor

StratiHealth

Status

Completed

Last Update Posted

Aug 20, 2018Actual

Enrollment

114Actual

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Respiratory Therapist Education and Case Management

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SH20140101S	Other Grant/Funding Number	STRATIHEALTH

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Mar 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Mar 1, 2014

First Submission Date that Met QC Criteria

Mar 3, 2014

First Posted Date

Mar 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2018

Last Update Posted Date

Aug 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

24 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

114Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COPD, Education and Case Management		Respiratory Therapist Education and Case Management	Other: Respiratory Therapist Education and Case Management

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Healthcare Utilization	Hospital Admission, Emergency Room Encounters	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who are diagnosed with COPD

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ISABEL PEREIRA, MD	StratiHealth	Principal Investigator
VERNON R PERTELLE, RRT	StratiHealth	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Isabel Pereira, Md		Carlsbad	California	92008	United States

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019090	Case Management

Ancestor Terms

ID	Term
D010347	Patient Care Planning
D003191	Comprehensive Health Care
D010346	Patient Care Management
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided