Trial Outcomes & Findings for REducing 30-day ADMIssions in posT-discharge Subjects (READMIT) (NCT NCT01574144)
NCT ID: NCT01574144
Last Updated: 2022-12-30
Results Overview
Percentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits.
Recruitment status
COMPLETED
Target enrollment
70 participants
Primary outcome timeframe
30 days post-discharge
Results posted on
2022-12-30
Participant Flow
Participant milestones
| Measure |
AVIVO™ PiiX Patch Monitor System
Heart failure patients monitored continuously for 30 days post-discharge.
AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge.
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
REducing 30-day ADMIssions in posT-discharge Subjects (READMIT)
Baseline characteristics by cohort
| Measure |
AVIVO™ PiiX Patch Monitor System
n=70 Participants
Heart failure patients monitored continuously for 30 days post-discharge.
AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge.
|
|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days post-dischargePercentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits.
Outcome measures
| Measure |
AVIVO™ PiiX Patch Monitor System
n=70 Participants
Heart failure patients monitored continuously for 30 days post-discharge.
AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge.
|
|---|---|
|
Percentage of Participants With Health Care Utilizations
|
28.6 percentage of participants
Interval 18.4 to 40.6
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SECONDARY outcome
Timeframe: Discharge to 30 days post dischargePopulation: All subjects with changes of body weight and impedance from discharge to 30 days post discharge.
Change in body weight per unit change in thoracic impedance. The regression coefficients between body weight and thoracic impedance.
Outcome measures
| Measure |
AVIVO™ PiiX Patch Monitor System
n=54 Participants
Heart failure patients monitored continuously for 30 days post-discharge.
AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge.
|
|---|---|
|
Change in Body Weight Per Unit Change in Thoracic Impedance
|
-0.03 lbs/Ohm
Interval -0.15 to 0.09
|
Adverse Events
AVIVO™ PiiX Patch Monitor System
Serious events: 14 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AVIVO™ PiiX Patch Monitor System
n=70 participants at risk
Heart failure patients monitored continuously for 30 days post-discharge.
AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge.
|
|---|---|
|
Cardiac disorders
Atrial Fribrillation
|
1.4%
1/70 • Number of events 1 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
Cardiac disorders
Cardiac Failure Acute
|
1.4%
1/70 • Number of events 1 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
Cardiac disorders
Cardiac Failure congrestive
|
5.7%
4/70 • Number of events 4 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
Cardiac disorders
Supraventricular Tachycardia
|
1.4%
1/70 • Number of events 1 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
Metabolism and nutrition disorders
HyperKalaemia
|
1.4%
1/70 • Number of events 1 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/70 • Number of events 1 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
Nervous system disorders
Syncope
|
2.9%
2/70 • Number of events 2 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
Psychiatric disorders
Mental Status Changes
|
2.9%
2/70 • Number of events 2 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
Renal and urinary disorders
Renal Failure Chronic
|
1.4%
1/70 • Number of events 1 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
Reproductive system and breast disorders
Scrotal Oedema
|
1.4%
1/70 • Number of events 1 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.4%
1/70 • Number of events 1 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
1/70 • Number of events 1 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
1.4%
1/70 • Number of events 1 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
Vascular disorders
Arteriovenous Fistula
|
1.4%
1/70 • Number of events 1 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
Other adverse events
| Measure |
AVIVO™ PiiX Patch Monitor System
n=70 participants at risk
Heart failure patients monitored continuously for 30 days post-discharge.
AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge.
|
|---|---|
|
Cardiac disorders
Cardiac Failure congestive
|
4.3%
3/70 • Number of events 3 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
General disorders
Application Site Bruise
|
1.4%
1/70 • Number of events 1 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
General disorders
Application Site Rash
|
2.9%
2/70 • Number of events 2 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
Investigations
Blood Thyroid Stimlating Hormone Increased
|
1.4%
1/70 • Number of events 1 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
Renal and urinary disorders
Dysuria
|
1.4%
1/70 • Number of events 1 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.4%
1/70 • Number of events 1 • From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it 1. Lead to death OR 2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR 3. Lead to fetal distress/death/defect
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place