Trial Outcomes & Findings for Louisiana State University Health Care Sciences Division (LSU HSCD) Tele-Health Projects: Adult CHF Patient Population (NCT NCT01148563)

NCT ID: NCT01148563

Last Updated: 2024-01-25

Results Overview

(Number of emergency department visits + number of inpatient stays) / person-year

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 136 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2024-01-25

Participant Flow

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.

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.

Participant milestones

Measure	Standard Care The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention.	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.
Overall Study STARTED	69	67
Overall Study COMPLETED	40	37
Overall Study NOT COMPLETED	29	30

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Louisiana State University Health Care Sciences Division (LSU HSCD) Tele-Health Projects: Adult CHF Patient Population

Baseline characteristics by cohort

Measure	Standard Care n=69 Participants The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention.	Tele-health Monitoring Group n=67 Participants 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.	Total n=136 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	54 Participants n=7 Participants	106 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants	13 Participants n=7 Participants	30 Participants n=5 Participants
Age, Continuous	57.623188 years STANDARD_DEVIATION 9.2801202 • n=5 Participants	56.641791 years STANDARD_DEVIATION 10.08855 • n=7 Participants	57.139706 years STANDARD_DEVIATION 9.6633502 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	29 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	38 Participants n=7 Participants	67 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants	67 participants n=7 Participants	136 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Used an Intention to Treat (ITT) Analysis. Missing outcome data were imputed as necessary.

(Number of emergency department visits + number of inpatient stays) / person-year

Outcome measures

Measure	Standard Care n=69 Participants The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention.	Tele-health Monitoring Group n=67 Participants 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.
Events Per Person-year	84 events/person-year Interval 66.0 to 106.0	57 events/person-year Interval 43.0 to 76.0

SECONDARY outcome

Timeframe: 12 months

Population: All heart failure patients included in the study

(emergency department costs + inpatient costs) / person-year

Outcome measures

Measure	Standard Care n=69 Participants The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention.	Tele-health Monitoring Group n=67 Participants 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.
U.S. Dollars Per Person-year	10363 U.S. dollars per person-year Standard Error 1630	7212 U.S. dollars per person-year Standard Error 279

Adverse Events

Standard Care

Serious events: 40 serious events

Other events: 0 other events

Deaths: 0 deaths

Tele-health Monitoring Group

Serious events: 31 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard Care n=69 participants at risk The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention.	Tele-health Monitoring Group n=67 participants at risk 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.
General disorders Any ER visit or Inpatient stay	58.0% 40/69 • Number of events 86 • 6 months per participant The adverse events were identified via both care management interaction with patients and by electronic medical record data.	46.3% 31/67 • Number of events 60 • 6 months per participant The adverse events were identified via both care management interaction with patients and by electronic medical record data.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ron Horswell

Louisiana State Univeristy Health Care Services Division

Phone: 225-763-2983

Email: rhorsw@lsuhsc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place