Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00752531 |
Other study ID # |
596 |
Secondary ID |
R01HL071690R01HL |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 2003 |
Est. completion date |
December 2012 |
Study information
Verified date |
October 2023 |
Source |
Johns Hopkins University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
All chronic obstructive pulmonary diseases (COPDs) block air flow to the lungs, and the two
most common forms, emphysema and chronic bronchitis, are the most common causes of
respiratory failure. Previous research shows that if COPD patients know more about their
disease and how to manage it themselves, they will improve their quality of life and reduce
their need for urgent care. However, traditional methods of teaching COPD patients about
their disease and self-management skills are expensive and require intensive work. A new,
less expensive way of reaching a large group of people with this information is needed to
help patients stay healthier and happier with their treatment. This study will create a
computer program that can help people learn about their disease and how to manage it
themselves. This study will then determine whether the computer program, called Home
Automated Telemanagement (HAT), helps patients with COPD in managing their disease and
following their treatment plans.
Description:
Chronic obstructive pulmonary disease (COPD) is the result of damage to the lungs, making it
hard for someone with COPD to breathe. The two most common forms of COPD are emphysema and
chronic bronchitis, which can cause respiratory failure and irreversible damage to the lungs.
There is no cure for COPD, but interventions that help patients understand their disease and
how to manage it themselves can improve patient quality of life and prevent crises that would
require urgent care. The National Heart, Lung, and Blood Institute and World Health
Organization's Global Health Initiative for Chronic Obstructive Lung Disease (GOLD) recommend
multiple components for maintaining care of patients with COPD, including regular patient
assessment, education concerning COPD, effective communication between patients and their
health care providers, patient compliance with treatment plans, implementation of behavioral
change models for increasing health, and social support for patients and caregivers. Evidence
suggests that these guidelines are not used widely, possibly because they are labor intensive
and expensive and require frequent visits to a medical facility. Because effective
interventions are not being used by patients and because previous studies show
telecommunication technologies are successful in patient self-care, this study will develop a
home automated telemanagement (HAT) system incorporating many of the GOLD guidelines for use
in patients' homes.
HAT will be an Internet-based system providing ongoing education for patients about COPD,
helping patients follow their self-care plans, and helping health care providers monitor
patients' self-management through daily access. The system will consist of three pieces: (1)
patient units that include a computer or palmtop Internet accessible device equipped with a
disease-specific testing device, (2) a HAT server to analyze and store self-testing results,
and (3) clinician units that can review patient results on the Internet. By incorporating
text, audio, and visual components, the system will provide advice on self-care plans
tailored to each patient and will notify health care providers of each patient's plan
compliance.
This study has two phases. In the first, a HAT system for COPD will be refined based on user
interviews and focus groups. In the second, researchers will test its effectiveness in
keeping people with COPD healthy and ensuring they follow their self-care plans.
During the second phase of the study, which will last 18 months, all participants will be
provided with an Internet-capable computer. All participants will continue seeing their own
doctors and following a regular treatment plan prescribed by their doctors. Some will be
randomly assigned to also receive the HAT system. Those given the HAT system will take a
1-hour training course on its use and be expected to use it daily for a 10- to 15-minute
self-assessment and disease diary entry. The HAT system will also have other assessment,
counseling, and education tools that participants can use. Participants will be assessed
seven times, with four assessments at the research site and three at the home of each
participant. Assessments will be conducted every 3 months, with those at the research site
scheduled at baseline and Months 6, 12, and 18. Participants will complete questionnaires and
be interviewed at each assessment to measure the severity of their disease, well-being, and
attitudes toward the disease. During the assessments at the research site, additional tests
in breathing and physical fitness will be performed.