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OpenTrials
Completed

NCT Number: NCT01979055

Achieving Better Control for 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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-regulation intervention

Behavioral

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

Telephone follow-up

Behavioral

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

Primary outcomes

  1. Health care utilization

    Time frame: 12 months

    Health care utilization (ED visits, hospitalizations, and unscheduled urgent care visits)

Secondary outcomes

  1. Asthma Quality of Life

    Time frame: 12 months

    Asthma Quality of Life Questionnaire (AQLQ)

  2. Asthma control

    Time frame: 12 months

    Asthma Control test (ACT)

  3. Asthma costs

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 8, 2013
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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