AsthmaNCT00124085
Asthma in a Decentralized Patient Population: Is Traditional Disease Management Enough?
A study testing Disease Management and Disease Management + Educational Home Visits in people with Asthma, run by The University of Texas Health Science Center at San Antonio.
Trial summary
This is a health services demonstration project that evaluates three methods of health care delivery for the management of individuals with symptoms of asthma. This study will evaluate the impact of a telephonic asthma disease management process, with and without a home intervention program, on preventing… Read more about this study
- Who is it for?
- Ages 5 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Disease Management and Disease Management + Educational Home Visits
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,053 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Mar 2006
- 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 5 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Physician diagnosis of asthma
- One or more of the following:
- Acute visit with the primary diagnosis of asthma within the previous 6 months. (Includes visits to physician's office, emergency department, or any other health care facility.); OR
- Three or more refills for inhaler medicine in the past 6 months, based on review of pharmaceutical records; OR
- Diagnosis of asthma based on asthma symptoms and pulmonary function testing.
Who cannot join
- Other lung disease(s) with a possible reactive component (i.e. chronic obstructive pulmonary disease [COPD])
- Any diagnosis requiring chronic systemic steroids
- Enrollment in any other asthma disease management program
- Pregnancy
- Plan to reside at current residence for less than 12 months.
About this study
Official title: Asthma in a Decentralized Patient Population: Is Traditional Disease Management Enough? A Randomized, Controlled Trial Comparing Traditional Care to Two Systems of Disease Management for a Decentralized Population of Patients in South Texas
This is a health services demonstration project that evaluates three methods of health care delivery for the management of individuals with symptoms of asthma. This study will evaluate the impact of a telephonic asthma disease management process, with and without a home intervention program, on preventing asthma-related morbidity through patient/family asthma education.
The investigators' central thesis is that comprehensive clinical disease management protocols for the management of asthma will improve clinical outcomes; reduce fiscal resource consumption; and improve both patient satisfaction and patient quality of life. Additionally, individualized, in-home patient education and environmental assessment, when added to the telephonic protocol, will further improve these measures. However, incremental improvement will vary according to the population's access to care.
Read the detailed description
This trial addresses the real-world concerns of asthma management through a disease management approach that will assist both the patient and the primary care physician by providing education, additional outpatient resources and additional access to health care personnel. This approach will stress empowering the patient to participate in his or her own health care at a higher level, which, in the case of asthma, is critical to wellness.
In a cooperative network of San Antonio medical centers, civilian and military, with a collective mission to care for military beneficiaries and the underserved patients of South Texas, this trial will evaluate the clinical benefits, as well as the cost savings, of a chronic disease management intervention in asthma. This study will fill a conspicuous gap in the medical literature by addressing the effectiveness of disease management through a large, decentralized, randomized, controlled trial.
DISEASE MANAGEMENT INTERVENTION
The project will use asthma disease management protocols and educational materials developed by the National Jewish Medical and Research Center. The program will be fully available in both English and Spanish, allowing a direct test of its impact on the State's vulnerable Hispanic population. Based on the principles of comprehensive disease management, National Jewish Medical and Research Center has developed a disease management program for asthma (DMP: Asthma) which addresses continuity of care by integrating traditional treatment methods with a program that focuses on creating a stronger partnership between the patient and the healthcare team, as well as greater patient empowerment. The primary program goal is empowering patients with the tools and resources they need for better self management of their prescribed treatment regimens and control of their environment. The program incorporates practice guidelines outlined by the National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH).
HOME VISIT INTERVENTION
In addition, the demonstration will evaluate the addition of a home-based disease management protocol focusing on patient education, to test for incremental improvement. Patients will be taught about their disease (symptoms, treatment, appropriate action plans), as well as about the healthcare system (how and when to access it). Based on the principles of comprehensive disease management and the unique needs of South Texas residents, the South Texas Asthma Management Program (STAMP) is designed for a diverse, mobile, underserved patient population. The protocol delivers up-front home-based education and environmental assessment, with follow-up visits focused on reinforcement of the earlier messages. The program ensures access to a primary care provider for patients who lack this critical member of the healthcare team. It also provides multiple resources for social services and guidance in appropriately accessing the healthcare system. The goal of the program is to equip patients, who have barriers to access due to a number of factors (lack of phone, language, remote location, etc), to navigate the healthcare system and effectively receive the care they need.
- Conditions
- Asthma
- Being tested
- Disease Management, Disease Management + Educational Home Visits
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease ManagementBehavioural
Disease Management + Educational Home VisitsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom-free days
Quality of Life Questionnaire (AQLQ, PAQLQ)
Rate of asthma-related hospitalizations over 18 months of enrollment
Rate of asthma-related emergency room (ER) visits over 18 months of enrollment
Secondary outcomes (4)
Pulmonary function testing
SF-36
Days of school/work missed
Drug usage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2005 (estimated)
- Study startOct 2003
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 1,053 participants
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- South Texas Veterans Health Care System, Brooke Army Medical Center, 59th Medical Wing, TRICARE Southwest, Department of Health and Human Services, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Gregory L Freeman, MD, Principal investigator, University of TexasJay I Peters, MD, Principal investigator, University of TexasStephen Inscore, MD, Principal investigator, University of TexasAutumn Dawn Galbreath, MD, Study director, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124085
- Sponsor's protocol ID
- 034-5001-057
- Status last verified
- Aug 2012
- First submitted
- 22 Jul 2005
- Last updated
- 9 Aug 2012
- Results posted
- No
Publications
Galbreath AD, Smith B, Wood PR, Inscore S, Forkner E, Vazquez M, Fallot A, Ellis R, Peters JI. Assessing the value of disease management: impact of 2 disease management strategies in an underserved asthma population. Ann Allergy Asthma Immunol. 2008 Dec;101(6):599-607. doi: 10.1016/S1081-1206(10)60222-0.
PubMed 19119703
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma in a Decentralized Patient Population: Is Traditional Disease Management Enough? A Randomized, Controlled Trial Comparing Traditional Care to Two Systems of Disease Management for a Decentralized Population of Patients in South Texas
- ClinicalTrials.gov ID
- NCT00124085
- Acronym / sponsor ID
- 034-5001-057
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,053 participants
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- South Texas Veterans Health Care System, Brooke Army Medical Center, 59th Medical Wing, TRICARE Southwest, Department of Health and Human Services, Centers for Disease Control and Prevention
- Study start
- Oct 2003
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 26 Jul 2005 (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 is a health services demonstration project that evaluates three methods of health care delivery for the management of individuals with symptoms of asthma. This study will evaluate the impact of a telephonic asthma disease management process, with and without a home intervention program, on preventing asthma-related morbidity through patient/family asthma education.
The investigators' central thesis is that comprehensive clinical disease management protocols for the management of asthma will improve clinical outcomes; reduce fiscal resource consumption; and improve both patient satisfaction and patient quality of life. Additionally, individualized, in-home patient education and environmental assessment, when added to the telephonic protocol, will further improve these measures. However, incremental improvement will vary according to the population's access to care.
Detailed description
This trial addresses the real-world concerns of asthma management through a disease management approach that will assist both the patient and the primary care physician by providing education, additional outpatient resources and additional access to health care personnel. This approach will stress empowering the patient to participate in his or her own health care at a higher level, which, in the case of asthma, is critical to wellness.
In a cooperative network of San Antonio medical centers, civilian and military, with a collective mission to care for military beneficiaries and the underserved patients of South Texas, this trial will evaluate the clinical benefits, as well as the cost savings, of a chronic disease management intervention in asthma. This study will fill a conspicuous gap in the medical literature by addressing the effectiveness of disease management through a large, decentralized, randomized, controlled trial.
DISEASE MANAGEMENT INTERVENTION
The project will use asthma disease management protocols and educational materials developed by the National Jewish Medical and Research Center. The program will be fully available in both English and Spanish, allowing a direct test of its impact on the State's vulnerable Hispanic population. Based on the principles of comprehensive disease management, National Jewish Medical and Research Center has developed a disease management program for asthma (DMP: Asthma) which addresses continuity of care by integrating traditional treatment methods with a program that focuses on creating a stronger partnership between the patient and the healthcare team, as well as greater patient empowerment. The primary program goal is empowering patients with the tools and resources they need for better self management of their prescribed treatment regimens and control of their environment. The program incorporates practice guidelines outlined by the National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH).
HOME VISIT INTERVENTION
In addition, the demonstration will evaluate the addition of a home-based disease management protocol focusing on patient education, to test for incremental improvement. Patients will be taught about their disease (symptoms, treatment, appropriate action plans), as well as about the healthcare system (how and when to access it). Based on the principles of comprehensive disease management and the unique needs of South Texas residents, the South Texas Asthma Management Program (STAMP) is designed for a diverse, mobile, underserved patient population. The protocol delivers up-front home-based education and environmental assessment, with follow-up visits focused on reinforcement of the earlier messages. The program ensures access to a primary care provider for patients who lack this critical member of the healthcare team. It also provides multiple resources for social services and guidance in appropriately accessing the healthcare system. The goal of the program is to equip patients, who have barriers to access due to a number of factors (lack of phone, language, remote location, etc), to navigate the healthcare system and effectively receive the care they need.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Physician diagnosis of asthma
- One or more of the following:
Key exclusion criteria (5 listed)
- Other lung disease(s) with a possible reactive component (i.e. chronic obstructive pulmonary disease [COPD])
- Any diagnosis requiring chronic systemic steroids
- Enrollment in any other asthma disease management program
- Pregnancy
- Plan to reside at current residence for less than 12 months.
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 |
|---|---|---|
| Disease Management | Behavioural | – |
| Disease Management + Educational Home Visits | Behavioural | – |
Primary outcome
Symptom-free days
Quality of Life Questionnaire (AQLQ, PAQLQ)
Rate of asthma-related hospitalizations over 18 months of enrollment
Rate of asthma-related emergency room (ER) visits over 18 months of enrollment
4 secondary outcomes
Pulmonary function testing
SF-36
Days of school/work missed
Drug usage
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 9 Aug 2012.
- Derived from this study: PubMed 19119703Galbreath AD, Smith B, Wood PR, Inscore S, Forkner E, Vazquez M, Fallot A, Ellis R, Peters JI. Assessing the value of disease management: impact of 2 disease management strategies in an underserved asthma population. Ann Allergy Asthma Immunol. 2008 Dec;101(6):599-607. doi: 10.1016/S1081-1206(10)60222-0.
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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.
Gregory L Freeman, MD principal investigator
University of Texas
Jay I Peters, MD principal investigator
University of Texas
Stephen Inscore, MD principal investigator
University of Texas
Questions about this trial
What is this clinical trial studying?
A study testing Disease Management and Disease Management + Educational Home Visits in people with Asthma, run by The University of Texas Health Science Center at San Antonio.
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 5 inclusion and 5 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 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Symptom-free days. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00124085, which also lists 1 linked publication.
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 9 Aug 2012.