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

NCT01708070 | Completed DMC

• 1 other identifier: HL 098240
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Depression; Anxiety

Keywords

asthma; depression; anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of urgent resource utilization visits for asthma

  Approximately 12 months

Other Outcomes (1)

• Severity of depressive symptoms

  Approximately 12 months

Study Arms (2)

Asthma self-management experimental

ACTIVE COMPARATOR

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

Asthma self-management control

OTHER

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

Behavioral: Asthma self-management

Interventions

Asthma self-management BEHAVIORAL

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; Asthma self-management experimental

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• known history of depressive or anxious symptoms

You may not qualify if:

• pregnant
• has cognitive deficits
• no access to telephone

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Weill Cornell Internal Medicine Associates/Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Asthma; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Carol A Mancuso, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 16, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 12, 2016

Record last verified: 2016-09

Locations

US (1)