Trial of Asthma Self-Management Education in Patients With Depressive Symptoms
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Asthma Depression Anxiety |
Behavioral: Asthma self-management |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research |
| Official Title: | Trial of Asthma Self-Management Education in Patients With Depressive Symptoms |
- Change in asthma-related quality of life [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]The primary outcome will be a comparison of within-patient change in Asthma Quality of Life Questionnaire scores between groups.
- Number of urgent resource utilization visits for asthma [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]An additional outcome will be the comparison of the number or urgent resource utilization visits for asthma.
- Severity of depressive symptoms [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]We will characterize and monitor the severity of depressive symptoms during the trial using standardized scales.
| Estimated Enrollment: | 66 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Asthma self-management experimental
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.
|
Behavioral: Asthma self-management
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.
|
|
Asthma self-management control
The control state will involve a self-management workbook and contracting to improve self-management behaviors.
|
Behavioral: Asthma self-management
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 years of age or older
- known history of depressive or anxious symptoms
Exclusion Criteria:
- pregnant
- has cognitive deficits
- no access to telephone
Contacts and Locations| United States, New York | |
| Weill Cornell Internal Medicine Associates/Hospital for Special Surgery | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Carol A Mancuso, MD | Hospital for Special Surgery, New York |
More Information
No publications provided
| Responsible Party: | Hospital for Special Surgery, New York |
| ClinicalTrials.gov Identifier: | NCT01708070 History of Changes |
| Other Study ID Numbers: | HL 098240 |
| Study First Received: | October 11, 2012 |
| Last Updated: | October 15, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Hospital for Special Surgery, New York:
|
asthma depression anxiety |
Additional relevant MeSH terms:
|
Anxiety Disorders Asthma Depression Depressive Disorder Mental Disorders Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive |
Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Behavioral Symptoms Mood Disorders |
ClinicalTrials.gov processed this record on May 16, 2013