- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01979055
Achieving Better Control for Older Adults With Asthma
Use of a Self-regulation Intervention to Improve Control and Outcomes in Older Adults With Asthma
Asthma in older adults has been overlooked, understudied, and inadequately treated. While asthma programs targeting the unique needs of children, teenagers, women, minorities, and other populations have been successfully developed, there are currently none for older adults. This is particularly distressing as the asthma hospitalization rates, mortality rates, quality of life, and control are significantly worse in the elderly as compared to other age groups. It is clear that novel approaches are needed to improve the care in this population.
The investigators group has been active in the research of asthma in the elderly. The investigators have analyzed national asthma data sets to look for disparities in older adults, have conducted qualitative research to determine factors associated with poor control in the elderly, and have performed a pilot study of a self-regulation intervention which was able to improve outcomes. The investigators also have over 20 years of experience in asthma self-regulation interventions and physician communication enhancement for multiple populations of asthma patients. The investigators will combine these strengths into their current protocol.
The intervention program will be based on the self-regulation theory of behavior, which will enhance the participants' ability to self-manage this chronic condition, actively involve the participant in their own health care management, and produce sustained results. In this proposal, the investigators will evaluate a self-regulation asthma intervention in a diverse population of older adults. The intervention will be personalized to the challenges and goals each individual faces, which will enhance its applicability in different populations. This intervention will incorporate standard asthma education, complementary techniques for which older adults have expressed a strong interest, and enhanced communication with each participant's physician. Asthma specific outcomes will be assessed at 1, 6, and 12 months. The primary goal of this intervention is to decrease health care utilization (emergency department, urgent care, hospital, and unscheduled visits) for older adults with asthma. The investigators will also assess the ability to improve quality of life, asthma symptoms, asthma control, lung function parameters, self-efficacy, and cost effectiveness.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48106
- University of Michigan
-
Detroit, Michigan, United States, 48201
- Wayne State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- above the age of 55
- persistent asthma,
- have a primary care physician (PCP) who is willing to receive email communication during the study.
Exclusion Criteria:
- any other significant cardiopulmonary disease (including chronic obstructive pulmonary disease)
- a greater than 20 pack-year smoking history
- lack of telephone access
- decreased cognitive capacity such that participation in the program would not be possible
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Self-regulation intervention
6 session educational intervention (3 telephone, 3 In-person), led by a health educator
|
6 session educational intervention (3 telephone, 3 In-person), led by a health educator
|
Placebo Comparator: Control group
3 telephone calls to assess any additional questions regarding asthma
|
Usual care group, will also receive 3 telephone calls to assess any questions they may have about asthma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health care utilization
Time Frame: 12 months
|
Health care utilization (ED visits, hospitalizations, and unscheduled urgent care visits)
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma Quality of Life
Time Frame: 12 months
|
Asthma Quality of Life Questionnaire (AQLQ)
|
12 months
|
Asthma control
Time Frame: 12 months
|
Asthma Control test (ACT)
|
12 months
|
Asthma costs
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alan Baptist, MD, MPH, University of Michigan
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00076471
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
Johann Wolfgang Goethe University HospitalCompleted
-
Parc de Salut MarRecruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Universita di VeronaCompleted
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
-
Johann Wolfgang Goethe University HospitalCompletedExercise-induced AsthmaGermany
Clinical Trials on Self-regulation intervention
-
University of MichiganEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMedication Adherence | Self-regulationUnited States
-
University of California, DavisEnrolling by invitationInfant Behavior | Infant Development | Self-Control | Self-Regulation, EmotionUnited States
-
University of North Carolina, Chapel HillCompletedObesity | Weight Loss | Weight Gain PreventionUnited States
-
Boston CollegeJoslin Diabetes CenterCompleted
-
Wayne State UniversityCompletedHypertension | HemodialysisUnited States
-
UNC Lineberger Comprehensive Cancer CenterCompletedBreast Neoplasms | Body Weight ChangesUnited States
-
University of HoustonAmerican Cancer Society, Inc.; Herald Cancer AssociationCompletedBreast Cancer | Breast NeoplasmsUnited States
-
Columbia UniversityNational Institute on Aging (NIA)Completed
-
Phoenix VA Health Care SystemCompletedChronic PainUnited States
-
Jacobs University Bremen gGmbHGuangdong Provincial People's Hospital; Maastricht University; Hong Kong Baptist... and other collaboratorsCompletedCARDIOVASCULAR DISEASES | HEART DISEASESChina, Germany, Netherlands