This Study Compared an in Home Asthma Management Program Provided by Nurses or Respiratory Therapist - Full Text View

Sponsored by:	The University of Texas Health Science Center at San Antonio
Information provided by:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT00639847

Purpose

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	Intervention
Asthma	Behavioral: In-home asthma management program (AMP) provided by nurses Behavioral: In-home asthma management program (AMP) provided by respiratory therapists

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Caregiver), Historical Control, Parallel Assignment
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

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:

Health care utilization (hospitalizations, hospital days, emergency room visits, clinic visits) and cost. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	159
Study Start Date:	October 1998
Study Completion Date:	December 2002
Primary Completion Date:	December 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
group 1: No Intervention 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: Active Comparator 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.)
Group 3: Active Comparator 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.)

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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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	UTHSCSA
Principal Investigator:	Terry S. Le Grand, PhD	UTHSCSA
Principal Investigator:	Donna D. Gardner, MSHP	UTHSCSA
Principal Investigator:	Jay I Peters, MD	UTHSCSA

More Information

Responsible Party:	University of Texas Health Science Center at San Antonio ( Jay Peters, MD )
Study ID Numbers:	989-0030-090
Study First Received:	March 13, 2008
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00639847
Health Authority:	United States: Institutional Review Board

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

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Quality of Life
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009