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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-health Monitoring | Device | Daily tele-health monitoring data will be collected from randomized participants. |
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| Measure | Description | Time Frame |
|---|---|---|
| Events Per Person-year | (Number of emergency department visits + number of inpatient stays) / person-year | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| U.S. Dollars Per Person-year | (emergency department costs + inpatient costs) / person-year | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee Arcement, MD | Louisiana State University Health Care Services Division | Principal Investigator |
| Michael Kaiser, MD | Louisiana State University Health Care Services Division | Study Chair |
| Ronald Horswell, PhD | Louisiana State University Health Care Services Division | Study Chair |
| Jay Besse, BS | Louisiana State University Health Care Services Divison | Study Chair |
| Timothy S. Church, MD, MPH, PhD | Pennington Biomedical Research Center | Study Chair |
| Valerie H. Myers, PhD | Pennington Biomedical Research Center | Study Chair |
| Donna H. Ryan, MD | Pennington Biomedical Research Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Earl K. Long Medical Center | Baton Rouge | Louisiana | 70805 | United States | ||
| Leonard J. Chabert Medical Center |
Of the original 137 subjects recruited, one subject in the treatment group withdrew from the study prior to having home monitoring equipment installed, leaving a total of 136 subjects.
Subjects were nested within LSU HCSD clinics. Potential subjects were approved by their physicians for inclusion in addition to meeting the stated inclusion criteria.
Study recruiters contacted the potentially-eligible subjects at the times of their next scheduled clinic visits. Recruitment Period: 3/9/09-8/31/10.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention. |
| FG001 | Tele-health Monitoring Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Houma |
| Louisiana |
| 70363 |
| United States |
| University Medical Center | Lafayette | Louisiana | 70506 | United States |
| WO Moss Regional Medical Center | Lake Charles | Louisiana | 70607 | United States |
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.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention. |
| BG001 | Tele-health Monitoring Group | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Events Per Person-year | (Number of emergency department visits + number of inpatient stays) / person-year | Used an Intention to Treat (ITT) Analysis. Missing outcome data were imputed as necessary. | Posted | Mean | 95% Confidence Interval | events/person-year | 12 months |
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| Secondary | U.S. Dollars Per Person-year | (emergency department costs + inpatient costs) / person-year | All heart failure patients included in the study | Posted | Mean | Standard Error | U.S. dollars per person-year | 12 months |
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6 months per participant
The adverse events were identified via both care management interaction with patients and by electronic medical record data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care | The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention. | 40 | 69 | 0 | 69 | ||
| EG001 | Tele-health Monitoring Group | 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. | 31 | 67 | 0 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any ER visit or Inpatient stay | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ron Horswell | Louisiana State Univeristy Health Care Services Division | 225-763-2983 | rhorsw@lsuhsc.edu |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D054160 | Systolic Murmurs |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006337 | Heart Murmurs |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| >=65 years |
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| Male |
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