Achieving Better Control for Older Adults With Asthma

Asthma Clinical Trial

Official title:

Use of a Self-regulation Intervention to Improve Control and Outcomes in Older Adults With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01979055
• Other study ID #: HUM00076471
• Status: Completed
• Phase: N/A
• First received: October 28, 2013
• Last updated: July 5, 2017
• Start date: November 2013
• Est. completion date: June 30, 2017

Study information

• Verified date: July 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Elderly

Intervention

Behavioral:
• Self-regulation intervention
6 session educational intervention (3 telephone, 3 In-person), led by a health educator
• Telephone follow-up
Usual care group, will also receive 3 telephone calls to assess any questions they may have about asthma

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Wayne State University	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health care utilization	Health care utilization (ED visits, hospitalizations, and unscheduled urgent care visits)	12 months
Secondary	Asthma Quality of Life	Asthma Quality of Life Questionnaire (AQLQ)	12 months
Secondary	Asthma control	Asthma Control test (ACT)	12 months
Secondary	Asthma costs		12 months