Trial of Asthma Self-Management Education in Patients With Depressive Symptoms

Depression Clinical Trial

Official title:

Trial of Asthma Self-Management Education in Patients With Depressive Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708070
• Other study ID #: HL 098240
• Status: Completed
• Phase: N/A
• First received: October 11, 2012
• Last updated: September 9, 2016
• Start date: October 2012
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Anxiety
• Asthma
• Depression

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Internal Medicine Associates/Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Severity of depressive symptoms	We will characterize and monitor the severity of depressive symptoms during the trial using standardized scales.	Approximately 12 months	No
Primary	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.	Approximately 12 months	No
Secondary	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.	Approximately 12 months	No