Clinical trial NCT00639847: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma management
cost
disease management
respiratory care
nursing
health care utilization
health related quality of life
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2008-03-20
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Health care utilization (hospitalizations, hospital days, emergency room visits, clinic visits) and cost.
timeFrame: 6 months
Secondary outcomes:
measure: Health related quality of life (SF-36 and St. George's Respiratory Questionnaire), oxygenation, pulmonary function, symptoms, patient satisfaction and asthma self-management score
timeFrame: 6 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas
name: David C Shelledy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Terry S. Le Grand, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Donna D. Gardner, MSHP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Jay I Peters, MD
role: PRINCIPAL_INVESTIGATOR
References: