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

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ClinicalTrials.gov Identifier: NCT00639847
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : March 24, 2008
Sponsor:
Information provided by:
The University of Texas Health Science Center at San Antonio

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: In-home asthma management program (AMP) provided by nurses Behavioral: In-home asthma management program (AMP) provided by respiratory therapists Not Applicable

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  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
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 Start Date : October 1998
Actual Primary Completion Date : December 2002
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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.)



Primary Outcome Measures :
  1. Health care utilization (hospitalizations, hospital days, emergency room visits, clinic visits) and cost. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639847


Locations
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229 - 3900
Sponsors and Collaborators
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
Principal Investigator: Jay I Peters, MD University of Texas

Responsible Party: Jay Peters, MD, University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00639847     History of Changes
Other Study ID Numbers: 989-0030-090
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: March 24, 2008
Last Verified: March 2008

Keywords provided by The University of Texas Health Science Center at San Antonio:
Asthma management
cost
disease management
respiratory care
nursing
health care utilization
health related quality of life

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases