Achieving Better Control for Older Adults With Asthma
Use of a Self-regulation Intervention to Improve Control and Outcomes in Older Adults With Asthma
1 other identifier
interventional
189
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable asthma
Started Nov 2013
Longer than P75 for not_applicable asthma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2017
CompletedJuly 11, 2017
July 1, 2017
3.7 years
October 28, 2013
July 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Health care utilization
Health care utilization (ED visits, hospitalizations, and unscheduled urgent care visits)
12 months
Secondary Outcomes (3)
Asthma Quality of Life
12 months
Asthma control
12 months
Asthma costs
12 months
Study Arms (2)
Self-regulation intervention
EXPERIMENTAL6 session educational intervention (3 telephone, 3 In-person), led by a health educator
Control group
PLACEBO COMPARATOR3 telephone calls to assess any additional questions regarding asthma
Interventions
6 session educational intervention (3 telephone, 3 In-person), led by a health educator
Usual care group, will also receive 3 telephone calls to assess any questions they may have about asthma
Eligibility Criteria
You may qualify if:
- above the age of 55
- persistent asthma,
- have a primary care physician (PCP) who is willing to receive email communication during the study.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Institute on Aging (NIA)collaborator
Study Sites (2)
University of Michigan
Ann Arbor, Michigan, 48106, United States
Wayne State University
Detroit, Michigan, 48201, United States
Related Publications (1)
Bennett GH, Carpenter L, Hao W, Song P, Steinberg J, Baptist AP. Risk factors and clinical outcomes associated with fixed airflow obstruction in older adults with asthma. Ann Allergy Asthma Immunol. 2018 Feb;120(2):164-168.e1. doi: 10.1016/j.anai.2017.10.004. Epub 2017 Dec 28.
PMID: 29290515DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Baptist, MD, MPH
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 28, 2013
First Posted
November 8, 2013
Study Start
November 1, 2013
Primary Completion
June 30, 2017
Study Completion
June 30, 2017
Last Updated
July 11, 2017
Record last verified: 2017-07