Dyspnea Self-Management: Internet or Face-to-Face
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|ClinicalTrials.gov Identifier: NCT00461162|
Recruitment Status : Completed
First Posted : April 17, 2007
Last Update Posted : August 18, 2014
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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD)||Behavioral: Internet DSMP Behavioral: Face-to-Face Dyspnea Self-management Behavioral: Attention Control||Phase 1 Phase 2|
At the present time, education about symptom management for patients and treatments, including exercise, are primarily provided within structured and episodic pulmonary rehabilitation (PR) programs. These PR programs are of short duration, are available for only a small percentage of people because they are expensive and not covered by all third party payers, and often require travel by patients who are disabled. Given estimates of 10 to 24 million U.S. adults with COPD,most of who would benefit from PR, only less than 0.1% can be accommodated at any given time. In the US the maintenance or exercise programs following PR are not reimbursed and, therefore, not available for most patients.
A number of self-management programs have been tested in multiple chronic diseases,but there has been less study of self-management programs for patients with COPD. The few self-management programs for COPD that include only education and limited skills training have not significantly improved symptoms. Home-based PR and self-management programs with nurse home visits have been studied and provide a less costly and accessible alternative. Clearly there is a growing need for more accessible and alternative avenues for providing ongoing support and therapy for COPD patients.
The Internet provides a new exciting delivery channel that offers patients with disabilities an opportunity for greater involvement in health care decision-making and unparalleled opportunities to learn, inform, and communicate with one another and for health care providers to support patients' self-management efforts. Several Internet-based studies for other chronic illnesses have increased self-efficacy for symptom management, perception of available support, and patients' involvement in health care decision making, while reducing symptoms and health care costs. The only published study evaluating the use of the internet to support self-management in COPD patients was our pilot study for this proposal. Our study demonstrated an improvement in both self-efficacy and dyspnea with daily activities measures. This study will expand on the findings of our pilot study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dyspnea Self-Management: Internet or Face-to-Face|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Experimental: 1: i-DSMP
Internet Dyspnea Self-management Program (i-DSMP)
Behavioral: Internet DSMP
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.
Experimental: 2: f-DSMP
Face-to-Face Dyspnea Self-management Program (f-DSMP)
Behavioral: Face-to-Face Dyspnea Self-management
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.
Active Comparator: 3: AC
Attention Control (AC)
Behavioral: Attention Control
6 Monthly general health education classes and biweekly telephone calls from a health educator.
- Dyspnea with ADL [ Time Frame: 3, 6, and 12 months ]
- Exercise and functional performance [ Time Frame: 3, 6, and 12 months ]
- Exercise adherence [ Time Frame: 3, 6, and 12 months ]
- Acute COPD exacerbations [ Time Frame: 3, 6, and 12 months ]
- Perception of social support [ Time Frame: 3, 6, and 12 months ]
- Self-efficacy for exercise and managing dyspnea [ Time Frame: 3, 6, and 12 months ]
- Health resource utilization [ Time Frame: 3, 6, and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461162
|United States, California|
|Dyspnea Research Group, Dept. of Physiological Nursing, University of California, San Francisco|
|San Francisco, California, United States, 94143|
|United States, Washington|
|University of Washington, Seattle - Dept. of Biobehavioral Nursing and Health Systems|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Virginia Carrieri-Kohlman, RN, DNSc||University of California, San Francisco|