Trial Outcomes & Findings for Home-HF: Evaluation of Patients With Heart Failure Using Home Telemonitoring (NCT NCT00312884)

NCT ID: NCT00312884

Last Updated: 2016-05-30

Results Overview

Days alive and outside of hospital (i.e. not admitted)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 182 participants
• Primary outcome timeframe: From date of randomisation for 180 days
• Results posted on: 2016-05-30

Participant Flow

Participant milestones

Measure	Intervention Arm Recieved home telemonitoring daily HomMed Telemonitoring System: The HomeMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home	Usual Care Received usual hospital care with no Telemonitoring
Overall Study STARTED	91	91
Overall Study COMPLETED	74	79
Overall Study NOT COMPLETED	17	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Home-HF: Evaluation of Patients With Heart Failure Using Home Telemonitoring

Baseline characteristics by cohort

Measure	Usual Care n=91 Participants Recieved usual follow-up care	Intervention Arm n=91 Participants Received daily home monitoring	Total n=182 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	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	61 Participants n=5 Participants	61 Participants n=7 Participants	122 Participants n=5 Participants
Age, Continuous	72 years STANDARD_DEVIATION 10.4 • n=5 Participants	70 years STANDARD_DEVIATION 12.8 • n=7 Participants	71 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	29 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	62 Participants n=7 Participants	121 Participants n=5 Participants
Region of Enrollment United Kingdom	91 participants n=5 Participants	91 participants n=7 Participants	182 participants n=5 Participants

PRIMARY outcome

Timeframe: From date of randomisation for 180 days

Days alive and outside of hospital (i.e. not admitted)

Outcome measures

Measure	Usual Care n=91 Participants Recieved usual hospital and community care HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home	Intervention Arm n=91 Participants Recieved telemonitoring HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
Days Alive and Outside of Hospital	180 Days Interval 165.0 to 180.0	178 Days Interval 90.0 to 180.0

PRIMARY outcome

Timeframe: From randomisation date to 180 days

Outcome measures

Measure	Usual Care n=91 Participants Recieved usual hospital and community care HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home	Intervention Arm n=91 Participants Recieved telemonitoring HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
Patients Hospitalised (All Cause)	23 participants	33 participants

PRIMARY outcome

Timeframe: From randomisation date for 180 days

Outcome measures

Measure	Usual Care n=91 Participants Recieved usual hospital and community care HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home	Intervention Arm n=91 Participants Recieved telemonitoring HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
Number of Days Spent in Hospital	17 days Interval 6.0 to 25.0	13 days Interval 8.0 to 34.0

PRIMARY outcome

Timeframe: from randomisation for 180 days

Outcome measures

Measure	Usual Care n=91 Participants Recieved usual hospital and community care HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home	Intervention Arm n=91 Participants Recieved telemonitoring HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
Number of Hospitalisations (All Cause)	39 Number of hospitalisations	44 Number of hospitalisations

Adverse Events

Usual Care

Serious events: 23 serious events

Other events: 10 other events

Deaths: 0 deaths

Intervention Arm

Serious events: 33 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual Care n=91 participants at risk Recieved usual hospital care	Intervention Arm n=91 participants at risk Recieved telemonitoring daily via the HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
Cardiac disorders Hospitalisation	25.3% 23/91 • Number of events 39 Adverse events were collected without regard for teh specific adverse event term.	36.3% 33/91 • Number of events 44 Adverse events were collected without regard for teh specific adverse event term.

Other adverse events

Measure	Usual Care n=91 participants at risk Recieved usual hospital care	Intervention Arm n=91 participants at risk Recieved telemonitoring daily via the HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
Cardiac disorders Heart Failure Admission	11.0% 10/91 • Number of events 16 Adverse events were collected without regard for teh specific adverse event term.	18.7% 17/91 • Number of events 22 Adverse events were collected without regard for teh specific adverse event term.

Additional Information

Professor Cowie

Imperial College london

Phone: 0207 349 7716

Email: m.cowie@imperial.ac.uk

Results disclosure agreements

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