NCT00639847

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Oct 1998

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1998

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
Last Updated

March 24, 2008

Status Verified

March 1, 2008

Enrollment Period

4.2 years

First QC Date

March 13, 2008

Last Update Submit

March 21, 2008

Conditions

Asthma

Keywords

Asthma managementcostdisease managementrespiratory carenursinghealth care utilizationhealth related quality of life

Outcome Measures

Primary Outcomes (1)

  • Health care utilization (hospitalizations, hospital days, emergency room visits, clinic visits) and cost.

    6 months

Secondary Outcomes (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

    6 months

Study Arms (3)

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

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

Interventions

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

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 2
In-home asthma management program (AMP) provided by respiratory therapistsBEHAVIORAL

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

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Included other pulmonary disorders or diagnosis of co-morbid disease which was disabling in nature.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229 - 3900, United States

Location

MeSH Terms

Conditions

AsthmaPatient Acceptance of Health Care

Interventions

Adenosine Monophosphate

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Adenine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 13, 2008

First Posted

March 20, 2008

Study Start

October 1, 1998

Primary Completion

December 1, 2002

Study Completion

December 1, 2002

Last Updated

March 24, 2008

Record last verified: 2008-03

Locations

US(1)