AsthmaNCT01708070
Trial of Asthma Self-Management Education in Patients With Depressive Symptoms
A study testing Asthma self-management in people with Asthma and Depression, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Although depressive and anxious symptoms are common in asthma patients and are associated with worse clinical and resource utilization outcomes, there have been no studies focusing on the particular challenges of improving asthma self-management in this population. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Asthma, Depression, Anxiety
- What is being tested?
- Asthma self-management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to May 2016
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- known history of depressive or anxious symptoms
Who cannot join
- pregnant
- has cognitive deficits
- no access to telephone
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Internal Medicine Associates/Hospital for Special Surgery
New York, New York, 10021
About this study
Although depressive and anxious symptoms are common in asthma patients and are associated with worse clinical and resource utilization outcomes, there have been no studies focusing on the particular challenges of improving asthma self-management in this population. The investigators hypothesize that a tailored intervention to improve asthma self-management in patients with a known history of depressive and anxious symptoms will be effective in improving asthma-related quality of life.
Read the detailed description
Depressive and anxious conditions are common during the lifetime of asthma patients and have been shown to be associated with worse asthma as defined by more symptoms, more hospitalizations and greater use of medications. There have been few studies trying to improve asthma outcomes in patients with known depression. One method to improve outcomes is to instruct patients in ways to better self manage asthma. The goal of this study is to test a comprehensive intervention to improve asthma self-management by increasing knowledge and self-efficacy in patients with a known history of a positive screen for depression. Patients will be randomized to two groups - a control group and an intervention group. Patients in the control group will receive an asthma workbook, will make a contract to adopt behaviors they think will improve asthma, and will receive telephone follow-ups approximately every week for 8 weeks and then approximately every 2 months. Patients in the intervention group will receive these components plus they will be taught how to use a peak flow meter and specific chapters of the workbook will be used as templates for focused instruction during telephone follow-ups. The primary outcome will be a comparison of within-patient change in asthma-related quality of life between groups.
- Conditions
- Asthma, Depression, Anxiety
- Being tested
- Asthma self-management
- Keywords
- asthma, depression, anxiety
- Medical subject headings
- Asthma, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma self-managementBehavioural
Patients in the intervention group will receive an asthma workbook, will make a contract to adopt behaviors they think will improve asthma, will be taught how to use a peak flow meter and specific chapters of the workbook will be used as templates for focused instruction during telephone follow-ups which will occur every week for 8 weeks and then approximately every 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Asthma self-management experimental | Active comparator | The intervention will involve a self-management workbook, contracting to improve self-management behaviors, instruction in using of a peak flow meter, and follow-up discussions based on the workbook. Receives: Behavioral: Asthma self-management |
| Asthma self-management control | Other | The control state will involve a self-management workbook and contracting to improve self-management behaviors. Receives: Behavioral: Asthma self-management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in asthma-related quality of life
The primary outcome will be a comparison of within-patient change in Asthma Quality of Life Questionnaire scores between groups.
Measured: Approximately 12 months
Secondary outcomes (1)
Number of urgent resource utilization visits for asthma
An additional outcome will be the comparison of the number or urgent resource utilization visits for asthma.
Measured: Approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2016
- Study completionMay 2016
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 Hospital for Special Surgery, New YorkThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carol A Mancuso, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708070
- Sponsor's protocol ID
- HL 098240
- Status last verified
- Sep 2016
- First submitted
- 11 Oct 2012
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Asthma Self-Management Education in Patients With Depressive Symptoms
- ClinicalTrials.gov ID
- NCT01708070
- Acronym / sponsor ID
- HL 098240
- Conditions
- Asthma, Depression, Anxiety
- Keywords
- asthma, depression, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Oct 2012 (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.
Although depressive and anxious symptoms are common in asthma patients and are associated with worse clinical and resource utilization outcomes, there have been no studies focusing on the particular challenges of improving asthma self-management in this population. The investigators hypothesize that a tailored intervention to improve asthma self-management in patients with a known history of depressive and anxious symptoms will be effective in improving asthma-related quality of life.
Detailed description
Depressive and anxious conditions are common during the lifetime of asthma patients and have been shown to be associated with worse asthma as defined by more symptoms, more hospitalizations and greater use of medications. There have been few studies trying to improve asthma outcomes in patients with known depression. One method to improve outcomes is to instruct patients in ways to better self manage asthma. The goal of this study is to test a comprehensive intervention to improve asthma self-management by increasing knowledge and self-efficacy in patients with a known history of a positive screen for depression. Patients will be randomized to two groups - a control group and an intervention group. Patients in the control group will receive an asthma workbook, will make a contract to adopt behaviors they think will improve asthma, and will receive telephone follow-ups approximately every week for 8 weeks and then approximately every 2 months. Patients in the intervention group will receive these components plus they will be taught how to use a peak flow meter and specific chapters of the workbook will be used as templates for focused instruction during telephone follow-ups. The primary outcome will be a comparison of within-patient change in asthma-related quality of life between groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma self-management experimental | Active comparator | Behavioral: Asthma self-managementThe intervention will involve a self-management workbook, contracting to improve self-management behaviors, instruction in using of a peak flow meter, and follow-up discussions based on the workbook. |
| Asthma self-management control | Other | Behavioral: Asthma self-managementThe control state will involve a self-management workbook and contracting to improve self-management behaviors. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- known history of depressive or anxious symptoms
Key exclusion criteria (3 listed)
- pregnant
- has cognitive deficits
- no access to telephone
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 |
|---|---|---|
| Asthma self-managementPatients in the intervention group will receive an asthma workbook, will make a contract to adopt behaviors they think will improve asthma, will be taught how to use a peak flow meter and specific chapters of the workbook will be used as templates for focused instruction during telephone follow-ups which will occur every week for 8 weeks and then approximately every 2 months. | Behavioural | Asthma self-management control, Asthma self-management experimental |
Primary outcome
Change in asthma-related quality of life
Time frame: Approximately 12 months
The primary outcome will be a comparison of within-patient change in Asthma Quality of Life Questionnaire scores between groups.
1 secondary outcome
Number of urgent resource utilization visits for asthma
Time frame: Approximately 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 12 Sep 2016.
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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.
Carol A Mancuso, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma self-management in people with Asthma and Depression, run by Hospital for Special Surgery, New York 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?
The sponsor lists 2 inclusion and 3 exclusion criteria. 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 12 Sep 2016. 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. 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?
Change in asthma-related quality of life (time frame: Approximately 12 months). 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 12 Sep 2016.