Clinical trial NCT04304833: Innovative Care of Older Adults With Chronic Heart Failure: A Comparative Effectiveness Clinical Trial (I-COACH)
Official title: Innovative Care of Older Adults With Chronic Heart Failure (I-COACH): A Comparative Effectiveness Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-03-11
Enrollment: 26
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

This is a single-blinded comparative effectiveness randomized controlled trial conducted in a real-world setting. A sample of 400 dyads, that is older patients with HF (\>55 years) and their caregivers, will be recruited from a large medical center and randomly assigned to one of two arms: 200 dyads to a provider-directed model or 200 dyads to the mHealth management model. 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 standard of care will be augmented by providing home equipment kits with weight scale, blood pressure, pulse oximetry devices and a Log to record data. 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. Outcomes informed a prior by community stakeholders to be most important at the patient, caregiver, and health systems-levels will be collected and compared at baseline, 3- and 6- months: 1) For the patient: self-care of HF; confidence and self-efficacy to manage care, symptoms, medications and treatments; HF knowledge; mental and physical health, health distress, informational support, equipment usability, and quality of life. 2) For the caregiver: caregiver burden and health. 3) For the Health System: patient satisfaction, hospital, emergency \& provider visits, and mortality. Differential benefits for subsets of participants will be evaluated according to patient characteristics (socio-demographical, rurality, etc.). Evaluation of mediation variables will enhance our understanding of underlying processes. This research has the potential to revolutionize care for high-cost and high-need patients such as those with HF.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Self-Care of Heart Failure Maintenance Scale (SCHFI)
timeFrame: Change from Baseline, 3 months, and 6 months
Secondary outcomes:
measure: Promis 43v2.1 Health Profile Anxiety 6a
timeFrame: Change from Baseline, 3 months, and 6 months
measure: Promis 43v2.1 Health Profile Depression 6a
timeFrame: Change from Baseline, 3 months, and 6 months
measure: Promis 43v2.1 Health Profile Fatigue 6a
timeFrame: Change from Baseline, 3 months, and 6 months
measure: Promis 43v2.1 Health Profile Pain Interference 6a
timeFrame: Change from Baseline, 3 months, and 6 months
measure: Promis 43v2.1 Health Profile Physical Function 6b
timeFrame: Change from Baseline, 3 months, and 6 months
measure: Promis 43v2.1 Health Profile Sleep Disturbance 6a
timeFrame: Change from Baseline, 3 months, and 6 months
measure: Promis 43v2.1 Health Profile Ability to Participate in Social Roles and Activities 6a
timeFrame: Change from Baseline, 3 months, and 6 months
measure: Promis 43v2.1 Health Profile PROMIS Pain Intensity Item (Global07)
timeFrame: Change from Baseline, 3 months, and 6 months
measure: Medical Outcomes Study MOS Health Distress Scale
timeFrame: Change from Baseline, 3 months, and 6 months
measure: Minnesota Living With Heart Failure Questionnaire (MLHFQ)
timeFrame: Change from Baseline to 6 months
Other outcomes:
measure: Zarit Caregiver Burden Scale
timeFrame: Change from baseline to 6 months
measure: Optum SF36v2 Health Survey
timeFrame: Change from baseline to 6 months
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Change from baseline to 3 months and 6 months
measure: Treatment Visits
timeFrame: Change from baseline to 3 months and 6 months
measure: Mortality
timeFrame: 3 months and 6 months
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Judith L Weber, PhD
role: PRINCIPAL_INVESTIGATOR
References: