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Achieving Better Control for Older Adults With Asthma

Primary Purpose

Asthma, Elderly

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-regulation intervention
Telephone follow-up
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, older adults, elderly, behavior

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan
  • Wayne State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Self-regulation intervention

Control group

Arm Description

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

3 telephone calls to assess any additional questions regarding asthma

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Asthma Quality of Life
Asthma Quality of Life Questionnaire (AQLQ)
Asthma control
Asthma Control test (ACT)
Asthma costs

Full Information

First Posted
October 28, 2013
Last Updated
July 5, 2017
Sponsor
University of Michigan
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT01979055
Brief Title
Achieving Better Control for Older Adults With Asthma
Official Title
Use of a Self-regulation Intervention to Improve Control and Outcomes in Older Adults With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Elderly
Keywords
asthma, older adults, elderly, behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-regulation intervention
Arm Type
Experimental
Arm Description
6 session educational intervention (3 telephone, 3 In-person), led by a health educator
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
3 telephone calls to assess any additional questions regarding asthma
Intervention Type
Behavioral
Intervention Name(s)
Self-regulation intervention
Intervention Description
6 session educational intervention (3 telephone, 3 In-person), led by a health educator
Intervention Type
Behavioral
Intervention Name(s)
Telephone follow-up
Intervention Description
Usual care group, will also receive 3 telephone calls to assess any questions they may have about asthma
Primary Outcome Measure Information:
Title
Health care utilization
Description
Health care utilization (ED visits, hospitalizations, and unscheduled urgent care visits)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Asthma Quality of Life
Description
Asthma Quality of Life Questionnaire (AQLQ)
Time Frame
12 months
Title
Asthma control
Description
Asthma Control test (ACT)
Time Frame
12 months
Title
Asthma costs
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Baptist, MD, MPH
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29290515
Citation
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.
Results Reference
derived

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Achieving Better Control for Older Adults With Asthma

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