N/A
N=112
Integrated Tele-monitoring and Patient-centric Health Coaching Strategy in Patients Hospitalized With Heart Failure
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02391987 ↗Enrolled (actual)
112
Serious AEs
3.6%
Results posted
Jan 2020
Primary outcome: Primary: Hospital Readmission — 14; 16 Participants — p=0.73
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tele-monitoring and health coaching (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hospital Readmission |
14; 16 | 0.73 |
| SECONDARY Number of Readmissions or Visits |
19; 20 | 0.98 |
| SECONDARY Mortality |
1; 4 | 0.37 |
Summary
This study evaluates the effectiveness of remote tele-monitoring and health coaching in helping to reduce hospitalizations in heart failure patients. Half of participants will receive tele-monitoring and health coaching, while the other half will receive standard health care provided by their chosen provider.
Eligibility Criteria
Inclusion Criteria
- Hospitalized with primary or secondary diagnosis of Acute Decompensated Heart Failure (one or more of these symptoms: shortness of breath, orthopnea or edema AND one or more of these signs: rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography)
- Adult patients >18 years old
Exclusion Criteria
- Overall life expectancy < 1 year
- Known skin allergy to adhesives (hydrocolloid, silicone, acrylic)
- Active systemic infection
- Pregnant or lactating
- End stage renal disease on dialysis
- Subject or caregiver is not visually and tactile capable of smartphone and home device usage
- Inadequate cell phone coverage (including international patients or international travel during study period)
- Subject or legal guardian is not willing and able to provide appropriate informed consent
Data sourced from ClinicalTrials.gov (NCT02391987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.