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

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Behavioral: Internet DSMP; Behavioral: Face-to-Face Dyspnea Self-management; Behavioral: Attention Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00461162

R01NR008938-01A2 (U.S. NIH Grant/Contract)

R01NR008938 (U.S. NIH Grant/Contract)

GCRC 43-09

Details and patient eligibility

About

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

Full description

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.

Enrollment: 125 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants will have:

  1. a diagnosis of COPD which is clinically stable (including medications) for at least one month;
  2. 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;
  3. ADL limited by dyspnea;
  4. a designated primary care physician;
  5. ability to speak English and sign consent form;
  6. actively using a computer and the Internet;
  7. no formal pulmonary rehabilitation training for at least 12 months;
  8. patients receiving supplemental oxygen will be acceptable if their O2 saturation can be maintained at >80% on <6L/min of nasal oxygen;
  9. understands how to and is able to rate their shortness of breath during exercise;
  10. age > 40 years.

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

125 participants in 3 patient groups

1: i-DSMP

Experimental group

Description:

Internet Dyspnea Self-management Program (i-DSMP)

Treatment:

Behavioral: Internet DSMP

2: f-DSMP

Experimental group

Description:

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

Treatment:

Behavioral: Face-to-Face Dyspnea Self-management

3: AC

Active Comparator group

Description:

Attention Control (AC)

Treatment:

Behavioral: Attention Control