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Innovative Care of Older Adults With Chronic Heart Failure: A Comparative Effectiveness Clinical Trial (I-COACH)

NCT04304833 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-10-10

Study results available
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Summary

An estimated 6.5 million adults in the U.S. have Heart Failure (HF) and the prevalence is increasing. HF is characterized by poor quality of life but this is amenable to self-management. However, the amount of support available from providers to help manage complications is far beyond what is feasible. The complex needs of these patients require a new vision for delivery of health care services, such as an mHealth management model. mHealth technologies such as blue-tooth enabled BP, heart rate, weight, and pulse oximetry remote monitoring permit sharing of immediate biometric data and video messages with providers and instantaneous feedback to patients before symptom crises, that is, when and where patients need it.

Conditions

Interventions

OTHER

Provider-Based Care Model Arm

The PI will be supplementing standard care by providing and training each patient in the use of an analog (not internet connected) vital sign kit for 6 months: weight scale, blood pressure cuff, pulse oximeter. A Log for recording their vital sign measures.

BEHAVIORAL

mHealth Model Arm

The PI will provide each patient with weight scale, blood pressure cuff, \& pulse oximeter kit connected to a Bluetooth-paired Android Health Tablet for 6 months. Daily vital sign readings will be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse Call Center will be automatically alerted and triaged.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Judith L Weber, PhD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2021-10-25
Completion
2021-10-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04304833 on ClinicalTrials.gov