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NCT04304833 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of Arkansas.

Terminated
Registry status
NA
Development phase
26
Enrollment target

NCT04304833: Clinical Trial NA study, sponsored by University of Arkansas.

NCT04304833 is a NA study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04304833, a NA study, was terminated before completion, sponsored by University of Arkansas.

TERMINATED
Registry status
NA
Development phase
26 participants
Enrollment target

Study 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.

Primary Outcome

self care scores on a scale range from 70 to 100, mean (SD). The SCHFI uses a Likert-type scale, with responses ranging from 1 (never) to 5 (always). The SCHFI also includes scales for self-care management and self-care confidence. Higher scores on the SCHFI indicate better self-care. A score of less than 70 on any of the subscales is considered inadequate self-care.

Interventions

  • OTHER Provider-Based Care Model Arm
  • BEHAVIORAL mHealth Model Arm

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2020-11-17
Est. Completion 2021-10-25
Phase NA
University of Arkansas

318 total trials

Why NCT04304833 stopped before completion

NCT04304833 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Provider-Based Care Model Arm is the first listed.

NCT04304833 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04304833 about?

NCT04304833 is a clinical study titled "Innovative Care of Older Adults With Chronic Heart Failure: A Comparative Effectiveness Clinical Trial (I-COACH)". 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 feasib...

What is the current status of trial NCT04304833?

This trial is currently terminated. It is a NA study. The enrollment target is 26 participants. The study started on 2020-11-17. Estimated completion is 2021-10-25.

What interventions are being tested in trial NCT04304833?

The interventions under investigation include: Provider-Based Care Model Arm (OTHER), mHealth Model Arm (BEHAVIORAL).

Who is sponsoring clinical trial NCT04304833?

This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04304833's enrollment target sits among peer trials

26 1710th of 2000 higher than 289 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04304833, the US trial registry maintained by the National Library of Medicine. NCT04304833 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.