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

March 21, 2008 updated by: The University of Texas Health Science Center at San Antonio

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229 - 3900
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: group 1
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.
Active Comparator: Group 2
Group 2 will receive routine home visits from nurses provided by a home health care agency.
Behavioral: In-home asthma management program (AMP) provided by nurses
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.)
Active Comparator: Group 3
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.)
Behavioral: 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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health care utilization (hospitalizations, hospital days, emergency room visits, clinic visits) and cost.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: David C Shelledy, PhD, University of Texas
  • Principal Investigator: Terry S. Le Grand, PhD, University of Texas
  • Principal Investigator: Donna D. Gardner, MSHP, University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1998

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

March 13, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 20, 2008

Study Record Updates

Last Update Posted (Estimate)

March 24, 2008

Last Update Submitted That Met QC Criteria

March 21, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 989-0030-090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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