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

Primary Purpose

Asthma, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Asthma self-management
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring asthma, depression, anxiety

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Cornell Internal Medicine Associates/Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Asthma self-management experimental

Asthma self-management control

Arm Description

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.

The control state will involve a self-management workbook and contracting to improve self-management behaviors.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 11, 2012
Last Updated
September 9, 2016
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT01708070
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Depression, Anxiety
Keywords
asthma, depression, anxiety

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asthma self-management experimental
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Asthma self-management control
Arm Type
Other
Arm Description
The control state will involve a self-management workbook and contracting to improve self-management behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Asthma self-management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in asthma-related quality of life
Description
The primary outcome will be a comparison of within-patient change in Asthma Quality of Life Questionnaire scores between groups.
Time Frame
Approximately 12 months
Secondary Outcome Measure Information:
Title
Number of urgent resource utilization visits for asthma
Description
An additional outcome will be the comparison of the number or urgent resource utilization visits for asthma.
Time Frame
Approximately 12 months
Other Pre-specified Outcome Measures:
Title
Severity of depressive symptoms
Description
We will characterize and monitor the severity of depressive symptoms during the trial using standardized scales.
Time Frame
Approximately 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol A Mancuso, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Internal Medicine Associates/Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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