Congestive Heart FailureTeleHealth:CHFNCT01148563
Louisiana State University Health Care Sciences Division (LSU HSCD) Tele-Health Projects: Adult CHF Patient Population
A study testing Tele-health Monitoring in people with Congestive Heart Failure, run by Pennington Biomedical Research Center at 4 sites in United States.
Trial summary
The purpose of this research study is to see whether a tele-health intervention can improve health, functioning status, emotional status, quality of life, and patient satisfaction for patients with Congestive Heart Failure (CHF) and to examine the cost benefits of this intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Tele-health Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2009to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- equal to or greater than 18 years old
- 1 + past CHF diagnosis in LSU database, with history of CHF diagnosis extending back for 12 months
- LSU primary care or chronic disease clinic patient for equal or greater than 6 months.
- On CHF medication for equal to or greater than 6 months
- Have had a past echocardiogram
- Mental competency to consent and participate (determined by clinical judgment and chart abstraction)
Show all 18Show fewer
- Physically able to use in-home equipment (or presence of a household member who can assist the subject in equipment use)
- Currently-working conventional telephone line at primary residence
- Grounded electrical power supply at primary residence
- Anticipation of remaining in the LSU HCSD patient population for the next year
- Not on home oxygen therapy
- No planned surgery within the next six months
- Living at home (not institutionalized)
- No history of major organ transplant
- No diagnosis of metastatic or inoperable cancer
- Not under treatment for cancer
- Not under treatment for end-stage renal disease or end-stage liver disease
- 1 + emergency department visit or inpatient stay in past 12 months
Who cannot join
- Are on home oxygen
- Have a planned surgery within the next 6 months
- Have a history of major organ transplant
- Have a diagnosis of metastatic or inoperable cancer
- Are under treatment for cancer
- Are under treatment for end-stage renal disease or end-stage liver disease
- Have HIV/AIDS
- Have a cognitive condition, such as Alzheimer's or dementia that would make it difficult for you to understand how to use the tele-health device.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Earl K. Long Medical Center
Baton Rouge, Louisiana, 70805
Leonard J. Chabert Medical Center
Houma, Louisiana, 70363
University Medical Center
Lafayette, Louisiana, 70506
WO Moss Regional Medical Center
Lake Charles, Louisiana, 70607
About this study
Official title: LSU HCSD Tele-Health Projects: Adult Systolic Heart Failure Patient Population
The purpose of this research study is to see whether a tele-health intervention can improve health, functioning status, emotional status, quality of life, and patient satisfaction for patients with Congestive Heart Failure (CHF) and to examine the cost benefits of this intervention.
- Conditions
- Congestive Heart Failure
- Being tested
- Tele-health Monitoring
- Keywords
- congestive heart failure, systolic, chronic disease, heart failure
- Medical subject headings
- Heart Failure, Systolic Murmurs, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-health MonitoringDevice
Daily tele-health monitoring data will be collected from randomized participants.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention. |
| Tele-health Monitoring Group | Active comparator | The tele-monitoring intervention group will have the continual standard care from their physician plus the tele-health monitoring. The tele-health monitor will collect the following data: weight, blood pressure, pulse oximetry, pulse rate, \& patient responses to disease-specific questions regarding changes in state of health for 6 months. Receives: Device: Tele-health Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Events Per Person-year
(Number of emergency department visits + number of inpatient stays) / person-year
Measured: 12 months
Secondary outcomes (1)
U.S. Dollars Per Person-year
(emergency department costs + inpatient costs) / person-year
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee Arcement, MD, Principal investigator, Louisiana State University Health Care Services DivisionMichael Kaiser, MD, Study chair, Louisiana State University Health Care Services DivisionRonald Horswell, PhD, Study chair, Louisiana State University Health Care Services DivisionJay Besse, BS, Study chair, Louisiana State University Health Care Services DivisonTimothy S. Church, MD, MPH, PhD, Study chair, Pennington Biomedical Research CenterValerie H. Myers, PhD, Study chair, Pennington Biomedical Research CenterDonna H. Ryan, MD, Study chair, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148563
- Sponsor's protocol ID
- PBRC 29003
- Acronym
- TeleHealth:CHF
- Status last verified
- Jan 2024
- First submitted
- 18 Jun 2010
- Last updated
- 25 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LSU HCSD Tele-Health Projects: Adult Systolic Heart Failure Patient Population
- ClinicalTrials.gov ID
- NCT01148563
- Acronym / sponsor ID
- TeleHealth:CHF / PBRC 29003
- Conditions
- Congestive Heart Failure
- Keywords
- congestive heart failure, systolic, chronic disease, heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 19 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to see whether a tele-health intervention can improve health, functioning status, emotional status, quality of life, and patient satisfaction for patients with Congestive Heart Failure (CHF) and to examine the cost benefits of this intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention. |
| Tele-health Monitoring Group | Active comparator | Device: Tele-health MonitoringThe tele-monitoring intervention group will have the continual standard care from their physician plus the tele-health monitoring. The tele-health monitor will collect the following data: weight, blood pressure, pulse oximetry, pulse rate, \& patient responses to disease-specific questions regarding changes in state of health for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- equal to or greater than 18 years old
- 1 + past CHF diagnosis in LSU database, with history of CHF diagnosis extending back for 12 months
- LSU primary care or chronic disease clinic patient for equal or greater than 6 months.
- On CHF medication for equal to or greater than 6 months
- Have had a past echocardiogram
Key exclusion criteria (8 listed)
- Are on home oxygen
- Have a planned surgery within the next 6 months
- Have a history of major organ transplant
- Have a diagnosis of metastatic or inoperable cancer
- Are under treatment for cancer
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 |
|---|---|---|
| Tele-health MonitoringDaily tele-health monitoring data will be collected from randomized participants. | Device | Tele-health Monitoring Group |
Primary outcome
Events Per Person-year
Time frame: 12 months
(Number of emergency department visits + number of inpatient stays) / person-year
1 secondary outcome
U.S. Dollars Per Person-year
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lee Arcement, MD principal investigator
Louisiana State University Health Care Services Division
Michael Kaiser, MD study chair
Louisiana State University Health Care Services Division
Ronald Horswell, PhD study chair
Louisiana State University Health Care Services Division
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-health Monitoring in people with Congestive Heart Failure, run by Pennington Biomedical Research Center at 4 sites 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 18 inclusion and 8 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 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 19 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Events Per Person-year (time frame: 12 months). 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 25 Jan 2024.