Clinical trial NCT01708070: Trial of Asthma Self-Management Education in Patients With Depressive Symptoms
Official title: Trial of Asthma Self-Management Education in Patients With Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Depression
Anxiety
Keywords: asthma
depression
anxiety
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in asthma-related quality of life
timeFrame: Approximately 12 months
Secondary outcomes:
measure: Number of urgent resource utilization visits for asthma
timeFrame: Approximately 12 months
Other outcomes:
measure: Severity of depressive symptoms
timeFrame: Approximately 12 months
Locations:
city: New York
country: United States
facility: Weill Cornell Internal Medicine Associates/Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Carol A Mancuso, MD
role: PRINCIPAL_INVESTIGATOR
References: