AsthmaNCT00941694
Asthma Self-Management in Older Adults
A study testing Self management intervention in people with Asthma and Aged, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- Self management intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Inclusion Criteria:: Age over 65, physician diagnosed asthma, need for daily asthma control medication, access to a telephone.
-
Exclusion Criteria: Smoking history greater than 40 pack years, current smoker, mental impairment that would preclude participation in the asthma self management program
-
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Self management intervention, placebo group
- Keywords
- asthma, aged, self care
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self management interventionBehavioural
Intervention arm will receive 6 group or individual sessions over a 7 week period
placebo groupBehavioural
3 phone calls not related to asthma self-management
| Study group | Role | What they receive |
|---|---|---|
| Self-Management Intervention | Experimental | Will receive 6 asthma self-management group or individual session over a 7 week period Receives: Behavioral: Self management intervention |
| Control | Placebo comparator | Group will receive 3 phone calls not related to asthma self management over a 7 week period Receives: Behavioral: placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Quality of Life Questionnaire
Measured: 3 months, 6 months, 1 year
Secondary outcomes (2)
Asthma Control Questionnaire
Measured: 3 months, 6 months, 12 months
Health Care Utilization
Measured: 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Baptist, University of Michigan
- Investigators
- Alan P Baptist, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941694
- Sponsor's protocol ID
- N011060
- Status last verified
- Jan 2013
- First submitted
- 17 Jul 2009
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Self-Management in Older Adults
- ClinicalTrials.gov ID
- NCT00941694
- Acronym / sponsor ID
- N011060
- Keywords
- asthma, aged, self care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Management Intervention | Experimental | Behavioral: Self management interventionWill receive 6 asthma self-management group or individual session over a 7 week period |
| Control | Placebo comparator | Behavioral: placebo groupGroup will receive 3 phone calls not related to asthma self management over a 7 week period |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self management interventionIntervention arm will receive 6 group or individual sessions over a 7 week period | Behavioural | Self-Management Intervention |
| placebo group3 phone calls not related to asthma self-management | Behavioural | Control |
Primary outcome
Asthma Quality of Life Questionnaire
Time frame: 3 months, 6 months, 1 year
2 secondary outcomes
Asthma Control Questionnaire
Time frame: 3 months, 6 months, 12 months
Health Care Utilization
Time frame: 3 months, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan P Baptist, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self management intervention in people with Asthma and Aged, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Quality of Life Questionnaire (time frame: 3 months, 6 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.