NCT00941694

Brief Summary

Asthma self-management is an effective way to improve the outcomes of patients with asthma. However, to be most effective these interventions should be targeted and designed toward a specific population or group. There is currently no asthma self-management intervention directed towards older adults. The hypothesis is that a 6-session asthma self-management intervention will improve the outcomes of older patients with asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

3.4 years

First QC Date

July 17, 2009

Last Update Submit

January 15, 2013

Conditions

AsthmaAged

Keywords

asthmaagedself care

Outcome Measures

Primary Outcomes (1)

  • Asthma Quality of Life Questionnaire

    3 months, 6 months, 1 year

Secondary Outcomes (2)

  • Asthma Control Questionnaire

    3 months, 6 months, 12 months

  • Health Care Utilization

    3 months, 6 months, 12 months

Study Arms (2)

Self-Management Intervention

EXPERIMENTAL

Will receive 6 asthma self-management group or individual session over a 7 week period

Behavioral: Self management intervention

Control

PLACEBO COMPARATOR

Group will receive 3 phone calls not related to asthma self management over a 7 week period

Behavioral: placebo group

Interventions

Self management interventionBEHAVIORAL

Intervention arm will receive 6 group or individual sessions over a 7 week period

Self-Management Intervention
placebo groupBEHAVIORAL

3 phone calls not related to asthma self-management

Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Alan P Baptist, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 17, 2009

First Posted

July 20, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)