Overview

This trial is active, not recruiting.

Conditions asthma, elderly
Treatments self-regulation intervention, telephone follow-up
Phase phase 2/phase 3
Sponsor University of Michigan
Collaborator National Institute on Aging (NIA)
Start date November 2013
End date May 2017
Trial size 189 participants
Trial identifier NCT01979055, HUM00076471

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
6 session educational intervention (3 telephone, 3 In-person), led by a health educator
self-regulation intervention
6 session educational intervention (3 telephone, 3 In-person), led by a health educator
(Placebo Comparator)
3 telephone calls to assess any additional questions regarding asthma
telephone follow-up
Usual care group, will also receive 3 telephone calls to assess any questions they may have about asthma

Primary Outcomes

Measure
Health care utilization
time frame: 12 months

Secondary Outcomes

Measure
Asthma Quality of Life
time frame: 12 months
Asthma control
time frame: 12 months
Asthma costs
time frame: 12 months

Eligibility Criteria

Male or female participants at least 55 years old.

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

Additional Information

Official title Use of a Self-regulation Intervention to Improve Control and Outcomes in Older Adults With Asthma
Principal investigator Alan Baptist, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Michigan.