NCT00752531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

9 years

First QC Date

September 11, 2008

Last Update Submit

October 10, 2023

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary DiseaseCOPD

Outcome Measures

Primary Outcomes (1)

  • Clinical health, including lung function and respiratory symptoms

    Measured at baseline and every 3 months for 18 months

Secondary Outcomes (5)

  • Disease-specific quality of life

    Measured at baseline and every 3 months for 18 months

  • Exercise tolerance

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

  • Urgent health care utilization

    Measured at baseline and every 3 months for 18 months

  • Self-efficacy for COPD patients

    Measured at baseline and every 3 months for 18 months

  • Activities of daily living (ADL)

    Measured at baseline and every 3 months for 18 months

Study Arms (2)

HAT

EXPERIMENTAL
Behavioral: Home Automated Telemanagement (HAT)

Control

NO INTERVENTION

Interventions

Home Automated Telemanagement (HAT)BEHAVIORAL

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.

Also known as: HAT
HAT

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • 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.

    PMID: 33511633DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph Finkelstein, MD, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2008

First Posted

September 15, 2008

Study Start

December 1, 2003

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 12, 2023

Record last verified: 2023-10

Locations

US(1)