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Behavioural Intervention

Control for Heart Failure

N/A
Waitlist Available
Led By Theresa Morrison, PhD
Research Sponsored by NCH Heatlhcare System Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 31 days
Awards & highlights

Study Summary

The study will test a hypothesis that the remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1) will have a higher return on investment compared to remote monitoring with nurse researcher follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2) and self-monitoring without intervention (Control).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~31 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 31 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects with unplanned re- hospitalization (heart failure-related and other hospitalization)
Secondary outcome measures
Communication with healthcare provider or emergency department
Cost of system and intervention per subjects
Health-related quality of life Questionnaire
+3 more
Other outcome measures
Number and type of incidents
Subject attrition

Trial Design

3Treatment groups
Experimental Treatment
Group I: Intervention 2Experimental Treatment1 Intervention
Intervention 2: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver, and a call will be placed by the nurse research assistant to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts). The physicians will have access to the subject's data on a web-based program.
Group II: Intervention 1Experimental Treatment1 Intervention
Intervention 1: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver.
Group III: ControlExperimental Treatment1 Intervention
Control: Peripherals with HealthInterlink technology will record and transmit data, without intervention. Subject is able to view graphed data, bring the HealthInterlink tablet/smartphone to the physician's office and share data with family/other caregiver.

Find a Location

Who is running the clinical trial?

NCH Heatlhcare System IncLead Sponsor
Welch AllynIndustry Sponsor
4 Previous Clinical Trials
735 Total Patients Enrolled
Theresa Morrison, PhDPrincipal InvestigatorNCH Healthcare System Inc

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Determine Return on Investment in Heart Failure Remote Monitoring Program
2015. "Determine Return on Investment in Heart Failure Remote Monitoring Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02475577.
All > Heart Failure With Preserved Ejection Fraction
~17 spots leftby Apr 2025
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