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The industry sponsor has discontinued the product under evaluation in the study.
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The proposed project is a 2x2 factorial designed study aimed at assessing the impact of 1) a home tele-monitoring system and 2) a flexible diuretic regimen among high risk heart failure patients in the University of Michigan Health System (UMHS).
The proposed project is a 2x2 factorial designed study aimed at assessing the impact of 1) a home tele-monitoring system and 2) a flexible diuretic regimen among high risk heart failure patients in the University of Michigan Health System (UMHS). The first intervention consists of the use of a home monitoring tool utilizing a tablet interface. The device facilitates collection of heart failure patient self-care information, including weight, blood pressure, heart rate and heart failure symptoms. This information is collected and stored on a secured server provided by the vendor, and can be viewed by the physician and nursing team. The second intervention is a flexible diuretic regimen strategy. This intervention will be applied in an independent randomized fashion. The flexible regimen will be prescribed by the patient's physician. The two interventions will be applied to heart failure patients treated at the University of Michigan. A total of 400 patients will be enrolled into the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Buddy Web Management system | Experimental | Patients randomized to the telemonitoring intervention will be assigned to use the Bosch Health Buddy Web management system. |
|
| Flexible Diuretic Regimen | Experimental | Patients randomized into the Flexible Diuretic Regimen intervention will have a diuretic regimen specified by specific weight ranges. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitoring | Device | The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Hospitalized or Dead in the 180 Day Follow up Period | This is the total combined number of days that all participants in each arm were hospitalized or dead between day 1 and day 180. It is a method to combine the endpoints of death and hospitalization used in heart failure trials. Days hospitalized for all participants are added to days dead for all participants, per arm. | 180 days (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Self Care for Heart Failure Index Score | The self care for heart failure index score ranges from 22 to 88 where 22 is the lowest score meaning cares for oneself least well and 88 means one is most confident or able to care for oneself properly. | 180 day follow up |
| Minnesota Living With Heart Failure Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd M Koelling, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
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Patients were randomized to one of 4 study groups:
Telemedicine intervention_YES and Flexible Diuretic_YES Telemedicine intervention_YES and Flexible Diuretic_NO Telemedicine intervention_NO and Flexible Diuretic_YES Telemedicine intervention_NO and Flexible Diuretic_NO
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| ID | Title | Description |
|---|---|---|
| FG000 | Health Buddy Yes and Flexible Diuretic Yes | Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer. Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges. |
| FG001 | Health Buddy Yes and Flexible Diuretic Regimen No | Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer. Flexible Diuretic Regimen: These patients will not be assigned to receive a flexible diuretic prescription |
| FG002 | Health Buddy No and Flexible Diuretic Yes | Telemonitoring: These patients will not receive care with the Health Buddy Web intervention. Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges. |
| FG003 | Health Buddy No and Flexible Diuretic No | Telemonitoring: These patients will not be assigned to the Health Buddy Web intervention. Flexible Diuretic Regimen: These patients will not be assigned to follow a flexible diuretic regimen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Group Number of subjects TM_YES_AND_FD_YES 13 TM_YES_AND_FD_NO 11 TM_NO_AND_FD_YES 14 TM_NO_AND_FD_NO 13
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| ID | Title | Description |
|---|---|---|
| BG000 | Health Buddy Yes and Flexible Diuretic Yes | Telemonitoring: Yes Flexible Diuretic Yes |
| BG001 | Health Buddy Yes and Flexible Diuretic No | Telemonitoring: Yes Flexible Diuretic No |
| 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 |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Days Hospitalized or Dead in the 180 Day Follow up Period | This is the total combined number of days that all participants in each arm were hospitalized or dead between day 1 and day 180. It is a method to combine the endpoints of death and hospitalization used in heart failure trials. Days hospitalized for all participants are added to days dead for all participants, per arm. | The subjects included in this measure each completed the 180 follow up period or died within the 180 follow up period. Subjects that had less than 180 days of follow up at the time of study closure are excluded from this analysis. | Posted | Number | Days | 180 days (6 months) |
|
180 days (or 6 months) from discharge date or from the day patient started using the intervention.
Subjects were expected to start the intervention on the day of discharge from the hospital, but some subjects once they returned home.
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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 | Health Buddy Web YES/Flexible Diuretic YES | Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer. Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congestive heart failure, | Cardiac disorders | Systematic Assessment | causing death |
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Early termination leading to a small number of subjects analyzed. We have enrolled a total of 51 patients when our target was to enroll 400 patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Todd Koelling, MD | University of Michgan Health Systems | 734-936-5265 | tkoellin@med.umich.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Flexible Diuretic Regimen | Other | Patients will have a prescribed diuretic regimen specified by specific weight ranges. |
|
It provides a total score (range 0-105, where 0 is best quality of life up to 105 as worst Health Related Quality of Life), |
| 180 day follow up |
| Days to Hospitalization or Death (if it Occurs Within 180 Days) | Time to Hospitalization (if participant was hospitalized and did not die) or death whichever came first. In fact all participants who died in the follow up period were hospitalized first, so actual data reported below also represents time to hospitalization for all participants. | 180 days |
| BG002 | Health Buddy No and Flexible Diuretic Yes | Telemonitoring: No Flexible Diuretic Yes |
| BG003 | Health Buddy No and Flexible Diuretic No | Telemonitoring: No Flexible Diuretic No |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Health Buddy Yes and Flexible Diuretic No |
Telemonitoring: Yes Flexible Diuretic No |
| OG002 | Health Buddy No and Flexible Diuretic Yes | Telemonitoring: No Flexible Diuretic Yes |
| OG003 | Health Buddy No and Flexible Diuretic No | Telemonitoring: No Flexible Diuretic No |
|
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| Secondary | Self Care for Heart Failure Index Score | The self care for heart failure index score ranges from 22 to 88 where 22 is the lowest score meaning cares for oneself least well and 88 means one is most confident or able to care for oneself properly. | Two participants completed the study but did not answer all of the questions on this questionnaire, and therefore they are not included in the report for this secondary end point. The subjects included completed the 180 follow up period. Subjects that had less than 180 days of follow up at the time of study closure are excluded from this analysis. | Posted | Mean | Full Range | units on a scale | 180 day follow up |
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|
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| Secondary | Minnesota Living With Heart Failure Questionnaire | It provides a total score (range 0-105, where 0 is best quality of life up to 105 as worst Health Related Quality of Life), | 2 patients completed the study, whose answers were not coded into the analysis for the questionnaire, therefore they are not included in the report for this secondary end point. The subjects included completed the 180 follow up period. Subjects that had less than 180 days of follow up at the time of study closure are excluded from this analysis. | Posted | Mean | Full Range | units on a scale | 180 day follow up |
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|
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| Secondary | Days to Hospitalization or Death (if it Occurs Within 180 Days) | Time to Hospitalization (if participant was hospitalized and did not die) or death whichever came first. In fact all participants who died in the follow up period were hospitalized first, so actual data reported below also represents time to hospitalization for all participants. | All participants who completed 180 days or died prior to 180 days (all who completed study and all listed in all cause mortality) | Posted | Mean | 95% Confidence Interval | days till hospitalization | 180 days |
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| 1 |
| 13 |
| 5 |
| 13 |
| 0 |
| 13 |
| EG001 | Health Buddy Web YES /Flexible Diuretic NO | Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer. Flexible Diuretic Regimen: These patients will not be assigned to receive a flexible diuretic prescription | 1 | 11 | 4 | 11 | 0 | 11 |
| EG002 | Health Buddy Web NO/Flexible Diuretic YES | Telemonitoring: These patients will not receive care with the Health Buddy Web intervention. Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges. | 2 | 14 | 7 | 14 | 0 | 14 |
| EG003 | Health Buddy Web NO /Flexible Diuretic NO | Telemonitoring: These patients will not be assigned to the Health Buddy Web intervention. Flexible Diuretic Regimen: These patients will not be assigned to follow a flexible diuretic regimen. | 1 | 13 | 6 | 13 | 0 | 13 |
| Occipital stroke | Nervous system disorders | Systematic Assessment | causing death |
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| Hospitalization | Cardiac disorders | Systematic Assessment | Heart failure |
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| ventricular tachycardia/ventricular fibrillation | Cardiac disorders | Systematic Assessment | causing death |
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| Death | Cardiac disorders | Systematic Assessment | cause unknown |
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