Congestive Heart FailurePhase 1/2NCT00261664
Empowering Elders Through Technology
A Phase 1/2 study testing telehomecare in people with Congestive Heart Failure, run by Robert Wood Johnson Foundation at 1 site in United States.
Trial summary
Telehomecare is a technology that individuals use in their homes to communicate with health providers electronically. This technology can help them function at a higher level and avoid undesirable hospitalizations by making changes in their everyday behaviors, but research is needed to understand how telehomecare… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- telehomecare
- Type of treatment
- Medical device
- How many people
- 290 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jul 2005
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- clinical diagnosis of congestive heart failure
- must have telephone line in home
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Telehomecare is a technology that individuals use in their homes to communicate with health providers electronically. This technology can help them function at a higher level and avoid undesirable hospitalizations by making changes in their everyday behaviors, but research is needed to understand how telehomecare supports health behavior change and leads to improved health status.
The hypothesis being tested is that the use of an electronic method of monitoring and transmitting health information facilitates patient empowerment, with subsequent effects on the patient's ability to manage her/his treatment regimen more effectively. The study will explore the relationship between telehomecare and acquisition of knowledge, and will show whether changes in knowledge levels translate to changes in behaviors and improved health outcomes. The effects of two different telehomecare systems (nurse-directed vs. patient-directed) on knowledge, self-management, and health status will be compared. A further goal is to illuminate the attitudes of physicians regarding the use of telehomecare in the treatment of their elderly, community dwelling patients.
Results will inform managers and policymakers who are responsible for integrating eHealth mechanisms into chronic disease protocols, funding health care programs, and creating policies that support the use of information technology by all Americans.
Read the detailed description
This study, funded by the Robert Wood Johnson Foundation through its Health e-Technologies Initiative (www.hetinitiative.org) is investigating the impact of telehomecare on health outcomes of persons with heart failure. The study began on September 1, 2003 and ends on February 28, 2006.
This study targets elderly persons with congestive heart failure (CHF), a major health problem affecting more than 4 million Americans. The research hypothesis being tested is that the use of an electronic method of monitoring and transmitting health information facilitates patient empowerment, with subsequent effects on the patient's ability to manage her/his treatment regimen more effectively. The study will explore the linkages between telehomecare and acquisition of knowledge, and will show whether changes in knowledge levels translate to changes in behaviors and improved health outcomes.
The effects of two different telehomecare systems (nurse-directed vs. patient-directed) on knowledge, self-management, and health status will be compared. A further goal is to illuminate the attitudes of physicians regarding the use of telehomecare in the treatment of their elderly, community dwelling patients.
Specific objectives are:
- To evaluate the impact of telehomecare on patients' knowledge and self-management of heart failure, and cardiovascular health outcomes;
- To compare the effect of two different telehomecare systems on patients' knowledge and self-management of heart failure, and cardiovascular health outcomes;
- To investigate how the personal characteristics of older persons influence human-computer interaction and user satisfaction;
- To describe and predict the attitudes and intentions of physicians regarding the use of telehomecare applications; and,
- To analyze relationships among individual characteristics, information use, self-management of heart-failure and health status.
- Conditions
- Congestive Heart Failure
- Being tested
- telehomecare
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telehomecareDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-management of heart failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study startSep 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 290 participants
Sponsor and investigators
- Lead sponsor
- Robert Wood Johnson Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Investigators
- Kathryn Dansky, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261664
- Sponsor's protocol ID
- 49150
- Status last verified
- Jul 2011
- First submitted
- 2 Dec 2005
- Last updated
- 27 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Elders Through Technology
- ClinicalTrials.gov ID
- NCT00261664
- Acronym / sponsor ID
- 49150
- Conditions
- Congestive Heart Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants
- Lead sponsor
- Robert Wood Johnson FoundationUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- Sep 2003
- Study completion
- Jul 2005 (actual)
- First posted
- 5 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Telehomecare is a technology that individuals use in their homes to communicate with health providers electronically. This technology can help them function at a higher level and avoid undesirable hospitalizations by making changes in their everyday behaviors, but research is needed to understand how telehomecare supports health behavior change and leads to improved health status.
The hypothesis being tested is that the use of an electronic method of monitoring and transmitting health information facilitates patient empowerment, with subsequent effects on the patient's ability to manage her/his treatment regimen more effectively. The study will explore the relationship between telehomecare and acquisition of knowledge, and will show whether changes in knowledge levels translate to changes in behaviors and improved health outcomes. The effects of two different telehomecare systems (nurse-directed vs. patient-directed) on knowledge, self-management, and health status will be compared. A further goal is to illuminate the attitudes of physicians regarding the use of telehomecare in the treatment of their elderly, community dwelling patients.
Results will inform managers and policymakers who are responsible for integrating eHealth mechanisms into chronic disease protocols, funding health care programs, and creating policies that support the use of information technology by all Americans.
Detailed description
This study, funded by the Robert Wood Johnson Foundation through its Health e-Technologies Initiative (www.hetinitiative.org) is investigating the impact of telehomecare on health outcomes of persons with heart failure. The study began on September 1, 2003 and ends on February 28, 2006.
This study targets elderly persons with congestive heart failure (CHF), a major health problem affecting more than 4 million Americans. The research hypothesis being tested is that the use of an electronic method of monitoring and transmitting health information facilitates patient empowerment, with subsequent effects on the patient's ability to manage her/his treatment regimen more effectively. The study will explore the linkages between telehomecare and acquisition of knowledge, and will show whether changes in knowledge levels translate to changes in behaviors and improved health outcomes.
The effects of two different telehomecare systems (nurse-directed vs. patient-directed) on knowledge, self-management, and health status will be compared. A further goal is to illuminate the attitudes of physicians regarding the use of telehomecare in the treatment of their elderly, community dwelling patients.
Specific objectives are:
- To evaluate the impact of telehomecare on patients' knowledge and self-management of heart failure, and cardiovascular health outcomes;
- To compare the effect of two different telehomecare systems on patients' knowledge and self-management of heart failure, and cardiovascular health outcomes;
- To investigate how the personal characteristics of older persons influence human-computer interaction and user satisfaction;
- To describe and predict the attitudes and intentions of physicians regarding the use of telehomecare applications; and,
- To analyze relationships among individual characteristics, information use, self-management of heart-failure and health status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of congestive heart failure
- must have telephone line in home
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telehomecare | Device | – |
Primary outcome
Self-management of heart failure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Dansky principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing telehomecare in people with Congestive Heart Failure, run by Robert Wood Johnson Foundation 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 2 inclusion and 1 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 27 Jul 2011. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Self-management of heart failure. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2011.