Results Summary

What was the research about?

Heart failure is a long-term health problem that can cause shortness of breath, fatigue, and rapid heartbeat. Patients with heart failure often go to their clinicians, such as doctors or nurses, or the emergency room to manage their symptoms.

In this study, the research team planned to compare two approaches to help older patients with heart failure and their caregivers manage their illness:

  • Mobile health, or mHealth care. Patients received kits to measure their blood pressure, heart rate, weight, and pulse. The kits included a cloud-based clinician portal connected to a tablet paired with Bluetooth. The portal sent daily readings of these measures to a 24-hour call center staffed by registered nurses. The nurses recommended treatment as needed.
  • Enhanced usual care. Patients went to regular doctor visits in person or by phone. Patients could also receive weight scales, blood pressure and pulse monitors, and a paper log for caregivers to record data. Patients and caregivers contacted their clinicians if they had concerns about their results.

What did the research team do?

The research team planned to recruit 400 pairs of older patients with heart failure and their caregivers. But the COVID-19 pandemic delayed the start of the study. When the study started, the team was only able to enroll 13 pairs of patients and caregivers. Due to COVID-19, hospitals no longer allowed caregivers to be in patients’ hospital rooms, which made it harder to recruit caregivers. Also, many patients with heart failure were sicker than in the past due to delays in receiving care. The research team decided to end the study in July 2021.

Patients with heart failure, caregivers, and doctors helped plan the study.

What were the results?

PCORI is committed to making full information on all funded research projects publicly available. This summary doesn’t include results or the limits of the study, because the study was not able to be completed due to the COVID-19 pandemic.

Final Research Report

This project's final research report is expected to be available by June 2024.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The final report for this project included a descriptive summary of the work completed for the main PCORI-funded study and a complete report of the COVID-19 enhancement addition to the project. Considerable focus in the peer review process was on structuring the report to provide a clear narrative about the difficulties the researchers experienced when implementing the main study. For instance, the reviewers recommended that the researchers focus the report discussion on the lessons learned in the failure of the main project, with more detailed discussion of the COVID-19 enhancement study results.
  • The reviewers noted that the report did not provide enough information for how the researchers handled missing data in the enhancement study. The researchers acknowledged that there was considerable information missing about two covariates: participants’ education and income. The researchers explained that their results were not statistically significant; therefore, imputation for income and education would not change the overall conclusions. 
  • The researchers noted that the researchers included all patient visits that were in person or through telehealth in their study sample, without consideration of the purpose of the visits and whether there were differences in new versus follow-up visits between in-person care and telehealth, among other visit characteristics. The researchers acknowledged that the study would have been stronger if they could control for the purpose of the visits or were able to capture that information. However, the short amount of time they had to complete the enhancement study and other recruitment difficulties drove the researchers to instead expand their criteria to include any in-person or telehealth visit, but they asked participants to focus on their most recent visit.

Project Information

Judy Weber, PhD, RD
University of Arkansas for Medical Sciences
$3,570,515
Innovative Care Model for Older Adults with Chronic Heart Failure (I-Coach): A Comparative Effectiveness Clinical Trial

Key Dates

August 2019
June 2023
2019
2023

Study Registration Information

Tags

Has Results
Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 18, 2024