Telemedicine Technology Demonstration Project for Heart Failure

NCT02115620 | Completed

• 1 other identifier: 13-165A
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if telemedicine can help improve the health of patients with heart failure who have recently been hospitalized with heart problems, and are being discharged to a Skilled Nursing Facility. Telemedicine uses electronic communications to make patient/doctor visits possible from a distance. This study will use remote video to allow heart failure specialists at Providence St. Vincent Medical Center to provide clinical health care to patients at Marquis Hills. Electronic monitors (including an electronic scale and blood pressure machine), and phone calls with the Marquis Hill nursing staff will be used to track patients' health status. The nursing staff will provide the heart failure specialists with daily updates on patients' symptoms, weight, vital signs (heart rate, blood pressure, pulse), and results of blood tests. Additionally, some patients will be provided with monitoring devices that include an iPhone blood pressure monitor, and Smart Body Analyzer to use for 14 days. The Smart Body Analyzer measures weight, body fat percentage, and heart rate. It also measures indoor air quality. Special software on the iPhone will save this information and the information will be transmitted by secure email to the study doctors. Hypothesis: The patients followed by telemedicine will have fewer visits to the Emergency Department, fewer deaths, and fewer hospital re-admissions than last year's site-specific average for this patient population.

Conditions

Heart Failure

Keywords

Heart failure; Cardiac failure; Congestive Heart Failure; Cardiomyopathy; Myocardial Failure; Telemedicine; Telehealth; Remote Consultation

Outcome Measures

Primary Outcomes (1)

• Composite endpoint (re-admission/ Emergency Department visit/ death)

  The primary composite outcome of all-cause re-admission to the hospital/ Emergency Department visits/ death at 30 and 60 days will be compared to facility-specific historical event rates from the prior year.

  up to 60 days after patient is discharged from skilled nursing facility

Study Arms (1)

Telemedicine

EXPERIMENTAL

Patients will be followed using frequent communication of symptom status and physiologic data and remote consultations with Heart Failure specialists.

Other: Telemedicine

Interventions

Telemedicine OTHER

Daily updates on symptoms, weight, vital signs, and relevant labs will be communicated by phone with cardiology nurses at Providence Heart Clinic. Concerning changes in symptoms or signs will trigger a telemedicine clinic visit with a HF specialist using remote video/audio, virtual stethoscope technology, and VZ Cloud managed hosting. The consult will include a virtual face-face interview and physical examination between patient and HF clinician using Cisco Yabber Video, Littman e-stethoscope, and Verizon managed hosting. Medication changes, laboratory testing, additional virtual visits, or in-person clinic visits can be arranged as appropriate.

Telemedicine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Primary or secondary diagnosis of heart failure
• Being discharged to a skilled nursing facility

You may not qualify if:

• Life expectancy of \< 6 months

Sponsors & Collaborators

• Providence Health & Services: lead
• Verizon Wireless: collaborator

Study Sites (1)

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Jacob Abraham, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 16, 2014
• Study Start: March 23, 2014
• Primary Completion: August 26, 2015
• Study Completion: August 26, 2015
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

US (1)