Dyspnea Self-Management: Internet or Face-to-Face

NCT00461162 | Completed Phase 1

• 3 other identifiers: GCRC 43-09R01NR008938R01NR008938-01A2
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic obstructive pulmonary disease, including emphysema and chronic bronchitis, is the fourth most common cause of death and the second leading cause of disability in the United States. COPD is estimated to be responsible for more than 13.4 million physician visits and 13% of hospitalizations nationally. These hospitalizations are usually caused by acute exacerbations characterized by an increase in symptoms including dyspnea or shortness of breath (SOB), cough, wheezing, and sputum production. The significant disability for people with COPD is primarily due to the symptom of dyspnea (shortness of breath) that affects an individual's quality of life more than does the physiological impairment. Despite optimal medical and pharmacological therapy, most people with COPD continue to suffer from chronic and progressive dyspnea and other symptoms of cough and fatigue. We have previously shown that an individualized face-to-face dyspnea self-management program was effective in improving dyspnea with activities of daily living (ADL), physical functioning, and self-efficacy for managing dyspnea. Using an experimental longitudinal design, the i-DSMP will be compared to the Face-to-Face Dyspnea Self-Management Program (f-DSMP) and to an Attention Control (AC) intervention

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (4)

• Dyspnea with ADL

  3, 6, and 12 months

• Exercise and functional performance

  3, 6, and 12 months

• Exercise adherence

  3, 6, and 12 months

• Acute COPD exacerbations

  3, 6, and 12 months

Secondary Outcomes (3)

• Perception of social support

  3, 6, and 12 months

• Self-efficacy for exercise and managing dyspnea

  3, 6, and 12 months

• Health resource utilization

  3, 6, and 12 months

Study Arms (3)

1: i-DSMP

EXPERIMENTAL

Internet Dyspnea Self-management Program (i-DSMP)

Behavioral: Internet DSMP

2: f-DSMP

EXPERIMENTAL

Face-to-Face Dyspnea Self-management Program (f-DSMP)

Behavioral: Face-to-Face Dyspnea Self-management

3: AC

ACTIVE COMPARATOR

Attention Control (AC)

Behavioral: Attention Control

Interventions

Internet DSMP BEHAVIORAL

Internet Dyspnea Self-management Program (i-DSMP): Education and skills training for dyspnea management; an individualized tailored exercise plan; self-monitoring of exacerbation symptoms and exercise; and reinforcement/personalized feedback for self management. I-DSMP participants will receive their accessing the modules through the website and participating in weekly online group chat sessions with the research nurse and other participants.

1: i-DSMP

Face-to-Face Dyspnea Self-management BEHAVIORAL

Face-to-Face Dyspnea Self-management Program (f-DSMP): Education and skills training for dyspnea management; an individualized tailored exercise plan; self-monitoring of exacerbation symptoms and exercise; and reinforcement/personalized feedback for self management. F-DMSP participants will attend face-to-face group education sessions. The f-DSMP participants will be provide with a hard copy of the education modules and will participate in six 1-hour group sessions for a period of 6 weeks.

2: f-DSMP

Attention Control BEHAVIORAL

6 Monthly general health education classes and biweekly telephone calls from a health educator.

3: AC

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will have:
• a diagnosis of COPD which is clinically stable (including medications) for at least one month;
• spirometry results showing at least mild obstructive disease defined as post bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio \<0.70 with FEV1\<80% predicted or post-bronchodilator FEV1/FVC ratio \<0.60 with FEV1\>80% predicted;
• ADL limited by dyspnea;
• a designated primary care physician;
• ability to speak English and sign consent form;
• actively using a computer and the Internet;
• no formal pulmonary rehabilitation training for at least 12 months;
• patients receiving supplemental oxygen will be acceptable if their O2 saturation can be maintained at \>80% on \<6L/min of nasal oxygen;
• understands how to and is able to rate their shortness of breath during exercise;
• age \> 40 years.

You may not qualify if:

• Subjects will be excluded if they have active symptomatic illness (e.g., cancer, left heart failure, ischemic heart disease with known coronary artery or valvular heart disease, psychiatric illness, and neuromuscular disease).

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

Dyspnea Research Group, Dept. of Physiological Nursing, University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Washington, Seattle - Dept. of Biobehavioral Nursing and Health Systems

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Nguyen HQ, Donesky D, Reinke LF, Wolpin S, Chyall L, Benditt JO, Paul SM, Carrieri-Kohlman V. Internet-based dyspnea self-management support for patients with chronic obstructive pulmonary disease. J Pain Symptom Manage. 2013 Jul;46(1):43-55. doi: 10.1016/j.jpainsymman.2012.06.015. Epub 2012 Oct 13.

  PMID: 23073395 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Virginia Carrieri-Kohlman, RN, DNSc

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2007
• First Posted: April 17, 2007
• Study Start: January 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 18, 2014

Record last verified: 2014-08

Locations

US (2)