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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

  1. Symptom-free days

  2. Quality of Life Questionnaire (AQLQ, PAQLQ)

  3. Rate of asthma-related hospitalizations over 18 months of enrollment

  4. Rate of asthma-related emergency room (ER) visits over 18 months of enrollment

Secondary outcomes (4)
  1. Pulmonary function testing

  2. SF-36

  3. Days of school/work missed

  4. Drug usage

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2005 (estimated)
  2. Study startOct 2003
  3. Primary completionMar 2006
  4. Study completionMar 2006

Resources

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
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

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.

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