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Effectiveness of Home Automated Telemanagement in Chronic Obstructive Pulmonary Disorder

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Automated Telemanagement (HAT)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pulmonary Disease, Chronic Obstructive focused on measuring Chronic Obstructive Pulmonary Disease, COPD

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HAT

Control

Arm Description

Outcomes

Primary Outcome Measures

Clinical health, including lung function and respiratory symptoms

Secondary Outcome Measures

Disease-specific quality of life
Exercise tolerance
Urgent health care utilization
Self-efficacy for COPD patients
Activities of daily living (ADL)

Full Information

First Posted
September 11, 2008
Last Updated
October 10, 2023
Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00752531
Brief Title
Effectiveness of Home Automated Telemanagement in Chronic Obstructive Pulmonary Disorder
Official Title
Evaluation of Home Automated Telemanagement in COPD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Chronic Obstructive Pulmonary Disease, COPD

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HAT
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Home Automated Telemanagement (HAT)
Other Intervention Name(s)
HAT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical health, including lung function and respiratory symptoms
Time Frame
Measured at baseline and every 3 months for 18 months
Secondary Outcome Measure Information:
Title
Disease-specific quality of life
Time Frame
Measured at baseline and every 3 months for 18 months
Title
Exercise tolerance
Time Frame
Measured at baseline and at Months 6, 12, and 18
Title
Urgent health care utilization
Time Frame
Measured at baseline and every 3 months for 18 months
Title
Self-efficacy for COPD patients
Time Frame
Measured at baseline and every 3 months for 18 months
Title
Activities of daily living (ADL)
Time Frame
Measured at baseline and every 3 months for 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Finkelstein, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33511633
Citation
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.
Results Reference
derived

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Effectiveness of Home Automated Telemanagement in Chronic Obstructive Pulmonary Disorder

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