LINK-HF2 - Remote Monitoring Analytics in Heart Failure

Part of paid clinical trials in Palo Alto, California.

Sponsor
VA Office of Research and Development
Study ID
NCT04502563
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Remote monitoring and predictive analytics — OTHER
    Subjects will undergo remote monitoring, remote monitoring data will be analyzed on a predictive platform, alerts indicating HF worsening shared with treating team, and algorithmic response to alerts implements.
  • Sham comparator — OTHER
    Subjects will wear a sensor, but data from the sensor will not generate alerts and will not be shared with the treating team.

Study Details

Heart failure (HF) is a type of heart disease that leads to need of admissions to the hospital during worsening of symptoms. These admissions are expensive and very inconvenient for patients. The investigators have previously shown that monitoring of patients with a using a small wearable sensor combined with a mathematical model can detect worsening of HF before the patient needs medical care. In this study the investigators will test whether the remote monitoring and prediction of HF worsening can be used to find out when patients are at risk, change their treatment and avoid a hospitalization. The study will enroll 240 Veterans with HF and randomly assign half of them to monitoring and communication of the information on HF worsening to their medical teams. The investigators hope to find our how to best use this approach in routine care of HF. The investigators also plan to determine if this approach will indeed led to less admissions to the hospital among these patients, shorter hospital stays and better quality of life.

Key Dates

Start date
Apr 19, 2021
Status verified
Apr 2026
Primary completion
Aug 31, 2024
Completion
Oct 30, 2024

Study Design

Enrollment
176 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Active arm
    Subjects will undergo remote monitoring, remote monitoring data will be analyzed on a predictive platform, alerts indicating HF worsening shared with treating team, and algorithmic response to alerts implements.
  • Sham Comparator: Control
    Subjects will wear a sensor, but data from the sensor will not generate alerts and will not be shared with the treating team.

Primary Outcome Measure

Heart Failure Hospitalization Rate [ Time Frame: 90 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
VA Palo Alto Health Care System, Palo Alto, CAPalo AltoCalifornia94304-1207-
North Florida/South Georgia Veterans Health System, Gainesville, FLGainesvilleFlorida32608-1135-
VA Salt Lake City Health Care System, Salt Lake City, UTSalt Lake CityUtah84148-0001-
Hunter Holmes McGuire VA Medical Center, Richmond, VARichmondVirginia23249-0001-

Find similar trials in Palo Alto, CA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
VA Palo Alto Health Care System, Palo Alto, CA· Palo Alto, CANorth Florida/South Georgia Veterans Health System, Gainesville, FL· Gainesville, FLVA Salt Lake City Health Care System, Salt Lake City, UT· Salt Lake City, UTHunter Holmes McGuire VA Medical Center, Richmond, VA· Richmond, VA

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