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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01708070
First received: October 11, 2012
Last updated: March 27, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708070

Locations
United States, New York
Weill Cornell Internal Medicine Associates/Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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: March 27, 2014
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 July 23, 2014