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This Study Compared an in Home Asthma Management Program Provided by Nurses or Respiratory Therapist

Primary Purpose

Asthma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

In-home asthma management program (AMP) provided by nurses

In-home asthma management program (AMP) provided by respiratory therapists

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma management, cost, disease management, respiratory care, nursing, health care utilization, health related quality of life

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adult patients (age 18-64 years) treated in the ED or hospitalized for an acute exacerbation of asthma at the university teaching hospital were invited to participate.

Exclusion Criteria:

Included other pulmonary disorders or diagnosis of co-morbid disease which was disabling in nature.

Sites / Locations

University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Arm Label

group 1

Group 2

Group 3

Arm Description

this is the standard of care control group. The control group will be instructed to return to their regular physicians for routine follow up at a time to be specified by the physician.

Group 2 will receive routine home visits from nurses provided by a home health care agency.

In-home asthma management program (AMP) provided by respiratory therapists. The AMP included asthma education (medications use, monitoring, triggers, steps to manage asthma attacks), demonstration and training (peak flow meter use, MDI and nebulizer use, asthma diary), home environment assessment and suggestions for environmental changes (mattress covers, control of dust, pets, fumes, cleaning materials, cock roach control, etc.)

Outcomes

Primary Outcome Measures

Health care utilization (hospitalizations, hospital days, emergency room visits, clinic visits) and cost.

Secondary Outcome Measures

Health related quality of life (SF-36 and St. George's Respiratory Questionnaire), oxygenation, pulmonary function, symptoms, patient satisfaction and asthma self-management score

Full Information

NCT ID

NCT00639847

First Posted

March 13, 2008

Last Updated

March 21, 2008

Sponsor

The University of Texas Health Science Center at San Antonio

1. Study Identification

Unique Protocol Identification Number

NCT00639847

Brief Title

This Study Compared an in Home Asthma Management Program Provided by Nurses or Respiratory Therapist

Official Title

A Randomized Controlled Study to Evaluate the Role of an In Home Asthma Disease Management Program Provided by Respiratory Therapists in Improving Outcomes and Reducing the Cost of the Care

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

October 1998 (undefined)

Primary Completion Date

December 2002 (Actual)

Study Completion Date

December 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study compared an in-home asthma management program provided by nurses or respiratory therapists to see if those receiving program had fewer hospitalizations, clinic and emergency room visits and higher levels of satisfaction and health related quality of life.

Detailed Description

Background: Disease management may improve outcomes and reduce cost. We compared an in-home asthma management program (AMP) delivered by respiratory therapists (RTs) or nurses (RNs) to standard care (SC) in 159 adults with moderate to severe asthma to determine the effect on health care utilization (HCU), patient satisfaction (PS) and health related quality of life (HRQOL). Methods: This single center, prospective trial randomized subjects, age 18-64, to three groups: SC, AMP-RT or AMP-RN. Outcomes at six-months were HCU, cost, pulmonary function, symptoms, environmental assessment, asthma self-management, HRQOL (SF-36; St. Georges Respiratory Questionnaire [SGRQ]) and PS. Frequencies were compared using chi 2; all other variables were compared using ANOVA with a post-hoc test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma management, cost, disease management, respiratory care, nursing, health care utilization, health related quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

159 (Actual)

8. Arms, Groups, and Interventions

Arm Title

group 1

Arm Type

No Intervention

Arm Description

this is the standard of care control group. The control group will be instructed to return to their regular physicians for routine follow up at a time to be specified by the physician.

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

Group 2 will receive routine home visits from nurses provided by a home health care agency.

Arm Title

Group 3

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

In-home asthma management program (AMP) provided by nurses

Intervention Description

The AMP included asthma education (medications use, monitoring, triggers, steps to manage asthma attacks), demonstration and training (peak flow meter use, MDI and nebulizer use, asthma diary), home environment assessment and suggestions for environmental changes (mattress covers, control of dust, pets, fumes, cleaning materials, cock roach control, etc.)

Intervention Type

Behavioral

Intervention Name(s)

In-home asthma management program (AMP) provided by respiratory therapists

Intervention Description

Primary Outcome Measure Information:

Title

Health care utilization (hospitalizations, hospital days, emergency room visits, clinic visits) and cost.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Health related quality of life (SF-36 and St. George's Respiratory Questionnaire), oxygenation, pulmonary function, symptoms, patient satisfaction and asthma self-management score

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients (age 18-64 years) treated in the ED or hospitalized for an acute exacerbation of asthma at the university teaching hospital were invited to participate. Exclusion Criteria: Included other pulmonary disorders or diagnosis of co-morbid disease which was disabling in nature.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David C Shelledy, PhD

Organizational Affiliation

University of Texas

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Terry S. Le Grand, PhD

Organizational Affiliation

University of Texas

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Donna D. Gardner, MSHP

Organizational Affiliation

University of Texas

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jay I Peters, MD

Organizational Affiliation

University of Texas

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Health Science Center at San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229 - 3900

Country

United States

12. IPD Sharing Statement

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This Study Compared an in Home Asthma Management Program Provided by Nurses or Respiratory Therapist

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