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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Asthma; Anxiety
• Intervention / Treatment: Behavioral: Asthma self-management

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Internal Medicine Associates/Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of depressive symptoms	We will characterize and monitor the severity of depressive symptoms during the trial using standardized scales.	Approximately 12 months

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: October 11, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Estimate): September 12, 2016
• Last Update Submitted That Met QC Criteria: September 9, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: depression; asthma; anxiety
• Additional Relevant MeSH Terms: Behavioral Symptoms; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Depression; Asthma
• Other Study ID Numbers: HL 098240