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

October 11, 2012
March 27, 2014
October 2012
October 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01708070 on ClinicalTrials.gov Archive Site
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.
Same as current
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.
Same as current
 
Trial of Asthma Self-Management Education in Patients With Depressive Symptoms
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
  • Asthma
  • Depression
  • Anxiety
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.
  • 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.
    Intervention: Behavioral: Asthma self-management
  • Asthma self-management control
    The control state will involve a self-management workbook and contracting to improve self-management behaviors.
    Intervention: Behavioral: Asthma self-management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
66
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01708070
HL 098240
Yes
Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
Not Provided
Principal Investigator: Carol A Mancuso, MD Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP