Achieving Better Control for Older Adults With Asthma

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by University of Michigan
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alan Baptist, University of Michigan
ClinicalTrials.gov Identifier:
NCT01979055
First received: October 28, 2013
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Elderly
Behavioral: Self-regulation intervention
Behavioral: Telephone follow-up
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of a Self-regulation Intervention to Improve Control and Outcomes in Older Adults With Asthma

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Health care utilization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Health care utilization (ED visits, hospitalizations, and unscheduled urgent care visits)


Secondary Outcome Measures:
  • Asthma Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Asthma Quality of Life Questionnaire (AQLQ)

  • Asthma control [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Asthma Control test (ACT)

  • Asthma costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 368
Study Start Date: November 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Self-regulation intervention
6 session educational intervention (3 telephone, 3 In-person), led by a health educator
Behavioral: Self-regulation intervention
6 session educational intervention (3 telephone, 3 In-person), led by a health educator
Placebo Comparator: Control group
3 telephone calls to assess any additional questions regarding asthma
Behavioral: Telephone follow-up
Usual care group, will also receive 3 telephone calls to assess any questions they may have about asthma

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01979055

Contacts
Contact: Laurie Carpenter, MSW 734-615-7825 lauriemc@umich.edu

Locations
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Laurie Carpenter, MSW    734-615-7825    lauriemc@umich.edu   
Principal Investigator: Alan Baptist, MD, MPH         
Wayne State University Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Ronald Trendler       rtrendle@med.umich.edu   
Principal Investigator: Lavoisier Cardozo, MD         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Alan Baptist, MD, MPH University of Michigan
  More Information

No publications provided

Responsible Party: Alan Baptist, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT01979055     History of Changes
Other Study ID Numbers: HUM00076471
Study First Received: October 28, 2013
Last Updated: November 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
asthma
older adults
elderly
behavior

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 02, 2014