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

NCT ID: NCT00639847

Last Updated: 2008-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-10-31

Study Completion Date

2002-12-31

Brief Summary

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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

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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.

Conditions

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Asthma

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

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

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.)

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

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.)

Interventions

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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.)

Intervention Type 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.)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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University of Texas Health Science Center at San Antonio

Principal Investigators

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David C Shelledy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Terry S. Le Grand, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Donna D. Gardner, MSHP

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Jay I Peters, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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989-0030-090

Identifier Type: -

Identifier Source: org_study_id