NCT01979055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

3.7 years

First QC Date

October 28, 2013

Last Update Submit

July 5, 2017

Conditions

Keywords

asthmaolder adultselderlybehavior

Outcome Measures

Primary Outcomes (1)

  • Health care utilization

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

    12 months

Secondary Outcomes (3)

  • Asthma Quality of Life

    12 months

  • Asthma control

    12 months

  • Asthma costs

    12 months

Study Arms (2)

Self-regulation intervention

EXPERIMENTAL

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

Behavioral: Self-regulation intervention

Control group

PLACEBO COMPARATOR

3 telephone calls to assess any additional questions regarding asthma

Behavioral: Telephone follow-up

Interventions

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

Self-regulation intervention

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

Control group

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • above the age of 55
  • persistent asthma,
  • have a primary care physician (PCP) who is willing to receive email communication during the study.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

AsthmaBehavior

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Alan Baptist, MD, MPH

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 8, 2013

Study Start

November 1, 2013

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations