AsthmaNCT00639847
This Study Compared an in Home Asthma Management Program Provided by Nurses or Respiratory Therapist
A study testing In-home asthma management program (AMP) provided by nurses and In-home asthma management program (AMP) provided by respiratory therapists in people with Asthma, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- In-home asthma management program (AMP) provided by nurses and In-home asthma management program (AMP) provided by respiratory therapists
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1998to Dec 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Included other pulmonary disorders or diagnosis of co-morbid disease which was disabling in nature.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229 - 3900
About this study
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
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- In-home asthma management program (AMP) provided by nurses, In-home asthma management program (AMP) provided by respiratory therapists
- Keywords
- Asthma management, cost, disease management, respiratory care, nursing, health care utilization, health related quality of life
- Medical subject headings
- Asthma, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-home asthma management program (AMP) provided by nursesBehavioural
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.)
In-home asthma management program (AMP) provided by respiratory therapistsBehavioural
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.)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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.) Receives: Behavioral: In-home asthma management program (AMP) provided by respiratory therapists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health care utilization (hospitalizations, hospital days, emergency room visits, clinic visits) and cost.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startOct 1998
- Primary completionDec 2002
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Investigators
- David C Shelledy, PhD, Principal investigator, University of TexasTerry S. Le Grand, PhD, Principal investigator, University of TexasDonna D. Gardner, MSHP, Principal investigator, University of TexasJay I Peters, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639847
- Sponsor's protocol ID
- 989-0030-090
- Status last verified
- Mar 2008
- First submitted
- 13 Mar 2008
- Last updated
- 24 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00639847
- Acronym / sponsor ID
- 989-0030-090
- Conditions
- Asthma
- Keywords
- Asthma management, cost, disease management, respiratory care, nursing, health care utilization, health related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Oct 1998
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: In-home asthma management program (AMP) provided by nursesGroup 2 will receive routine home visits from nurses provided by a home health care agency. |
| Group 3 | Active comparator | Behavioral: In-home asthma management program (AMP) provided by respiratory therapistsIn-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.) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Included other pulmonary disorders or diagnosis of co-morbid disease which was disabling in nature.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-home asthma management program (AMP) provided by nursesThe 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.) | Behavioural | Group 2 |
| In-home asthma management program (AMP) provided by respiratory therapistsThe 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.) | Behavioural | Group 3 |
Primary outcome
Health care utilization (hospitalizations, hospital days, emergency room visits, clinic visits) and cost.
Time frame: 6 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Shelledy, PhD principal investigator
University of Texas
Terry S. Le Grand, PhD principal investigator
University of Texas
Donna D. Gardner, MSHP principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-home asthma management program (AMP) provided by nurses and In-home asthma management program (AMP) provided by respiratory therapists in people with Asthma, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health care utilization (hospitalizations, hospital days, emergency room visits, clinic visits) and cost. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2008.