Achieving Better Control for Older Adults With Asthma

NCT ID: NCT01979055

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2017-06-30

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.

Conditions

Asthma; Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Self-regulation intervention

6 session educational intervention (3 telephone, 3 In-person), led by a health educator

Group Type: EXPERIMENTAL

Self-regulation intervention

Intervention Type: BEHAVIORAL

6 session educational intervention (3 telephone, 3 In-person), led by a health educator

Control group

3 telephone calls to assess any additional questions regarding asthma

Group Type: PLACEBO_COMPARATOR

Telephone follow-up

Intervention Type: BEHAVIORAL

Usual care group, will also receive 3 telephone calls to assess any questions they may have about asthma

Interventions

Self-regulation intervention

6 session educational intervention (3 telephone, 3 In-person), led by a health educator

Intervention Type: BEHAVIORAL

Telephone follow-up

Usual care group, will also receive 3 telephone calls to assess any questions they may have about asthma

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Alan Baptist

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alan Baptist, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Wayne State University

Detroit, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29290515 (View on PubMed)

Other Identifiers

HUM00076471

Identifier Type: -

Identifier Source: org_study_id