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Pulmonary Disease, Chronic ObstructiveNCT00752531

Effectiveness of Home Automated Telemanagement in Chronic Obstructive Pulmonary Disorder

A study testing Home Automated Telemanagement (HAT) in people with Pulmonary Disease, Chronic Obstructive, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Home Automated Telemanagement (HAT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteUnited States
Study dates
Dec 2003to Dec 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Physician diagnosis of chronic obstructive pulmonary disorder (COPD)
  • Moderate to severe COPD according to NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification (Stages II to III)
  • Understands spoken English
  • Has a functional telephone line or cable at home

Who cannot join

  • Evidence that the participant may move from the study area before the completion of the study
  • Presence of any health condition that would preclude participation, such as a psychiatric diagnosis or physical disability that would severely affect a participant's ability to carry out study procedures
  • Inability to use telephone unassisted

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Johns Hopkins University

    Baltimore, Maryland, 21224

Other trials in United States

About this study

Official title: Evaluation of Home Automated Telemanagement in COPD

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.

Read the detailed 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.

Being tested
Home Automated Telemanagement (HAT)
Keywords
Chronic Obstructive Pulmonary Disease, COPD
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home Automated Telemanagement (HAT)Behavioural

    Also called HAT

    The HAT was designed as an Internet-based telemedicine system that (1) provides ongoing education to patients about their chronic disease, (2) helps patients follow their self-care plans, and (3) helps health care practitioners monitor their patients' self-management processes according to current clinical guidelines. During each telecommunication session, patients perform self-testing and receive structured disease-specific education, patient-tailored counseling, and advice on how to follow their individual self-care plans based on the current results of self-testing.

Study groups in NCT00752531
Study groupRoleWhat they receive
HATExperimentalNot described
Receives: Behavioral: Home Automated Telemanagement (HAT)
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical health, including lung function and respiratory symptoms

    Measured: Measured at baseline and every 3 months for 18 months

Secondary outcomes (5)
  1. Disease-specific quality of life

    Measured: Measured at baseline and every 3 months for 18 months

  2. Exercise tolerance

    Measured: Measured at baseline and at Months 6, 12, and 18

  3. Urgent health care utilization

    Measured: Measured at baseline and every 3 months for 18 months

  4. Self-efficacy for COPD patients

    Measured: Measured at baseline and every 3 months for 18 months

  5. Activities of daily living (ADL)

    Measured: Measured at baseline and every 3 months for 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2008 (estimated)
  2. Study startDec 2003
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00752531
Sponsor's protocol ID
596
Other IDs
R01HL071690, R01HL071690-01
Status last verified
Oct 2023
First submitted
11 Sep 2008
Last updated
12 Oct 2023
Results posted
No
Data monitoring committee
No

Publications

  • Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

    PubMed 33511633

Questions about this trial

What is this clinical trial studying?

A study testing Home Automated Telemanagement (HAT) in people with Pulmonary Disease, Chronic Obstructive, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical health, including lung function and respiratory symptoms (time frame: Measured at baseline and every 3 months for 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00752531, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.

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