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

NCT04304833 | Terminated Results DMC

• 1 other identifier: 260092
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Self-Care of Heart Failure Maintenance Scale (SCHFI)

  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.

  Change from Baseline, 3 months, and 6 months

Secondary Outcomes (10)

• Promis 43v2.1 Health Profile Anxiety 6a

  Change from Baseline, 3 months, and 6 months

• Promis 43v2.1 Health Profile Depression 6a

  Change from Baseline, 3 months, and 6 months

• Promis 43v2.1 Health Profile Fatigue 6a

  Change from Baseline, 3 months, and 6 months

• Promis 43v2.1 Health Profile Pain Interference 6a

  Change from Baseline, 3 months, and 6 months

• Promis 43v2.1 Health Profile Physical Function 6b

  Change from Baseline, 3 months, and 6 months

Other Outcomes (5)

• Zarit Caregiver Burden Scale

  Change from baseline to 6 months

• Optum SF36v2 Health Survey

  Change from baseline to 6 months

• Client Satisfaction Questionnaire (CSQ-8)

  Change from baseline to 3 months and 6 months

Study Arms (2)

Provider-Based Care Model Arm

ACTIVE COMPARATOR

Non-connected home vital sign equipment will be given to patients in this group. The patients in the group will be instructed to record their daily readings on a paper log provided by the research team. These monitoring devices will not transmit readings to a centralized location and no one will be alerted to out-of-range readings or compliance with taking daily vital sign measures. At the front page of the log, normal ranges will be described with brief instructions about what participants/caregivers should do if their readings are out-of-range. Logs will be collected at baseline, 3-months and 6-months.

Other: Provider-Based Care Model Arm

mHealth Model Arm

EXPERIMENTAL

Connected home vital sign equipment (mHealth) will be given to patients in this group. The patients will be instructed to take their daily readings, which will automatically be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse (RN) Call Center will be automatically alerted and the event will be triaged. Daily measures and medical follow-up from the measures will be counted and collected at baseline, 3-months, and 6-months.

Behavioral: mHealth Model Arm

Interventions

Provider-Based Care Model Arm OTHER

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.

Provider-Based Care Model Arm

mHealth Model Arm BEHAVIORAL

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.

mHealth Model Arm

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged \> 55 years with HF (documented in medical record).
• Has capacity to understand informed consent.
• Able to stand (briefly) without assistance.
• Has a designated caregiver.
• Agrees to be followed (treated) by UAMS physician/provider for 6 months after discharge.

You may not qualify if:

• Speaks a language other than English or Spanish.
• Active psychosis or other severe cognitive disorder that interferes with capacity to understand and comply with study procedures.
• A history of drug or alcohol abuse in the past 90 days (documented in medical record).

Sponsors & Collaborators

• University of Arkansas: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• Rhoads SJ, McSweeney J, Sadaka H, Jin J, Pirtle C, Sanford J. Experiences of Older Adults with Heart Failure Using Telemedicine During the COVID-19 Pandemic: A Qualitative Study. Telemed J E Health. 2025 Feb;31(2):191-199. doi: 10.1089/tmj.2024.0005. Epub 2024 Sep 30.

  PMID: 39348299 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

That the sample size was too small for analysis.

Results Point of Contact

• Title: Judith Weber
• Organization: University of Arkansas for Medical Sciences

weberjudithl@uams.edu

5012961982

Study Officials

• Judith L Weber, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The provider-directed management model is the current care standard for patients with HF; care delivery consists of office and emergency visits, with telephone or in person communications. The mHealth care management model consists of real time bio-monitoring kits and telemedicine visits using a secure wireless gateway with a cloud-based clinician portal connected to a Bluetooth-paired Android Tablet. Daily readings are transmitted to a 24-hour RN call center and triaged per protocols.

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 11, 2020
• Study Start: November 17, 2020
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-04

Locations

US (1)