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

Study Overview
=================
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.

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

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: Provider-Based Care Model Arm
* Behavioral: mHealth Model Arm


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Provider-Based Care Model Arm<br>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<br>* 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.<br>|
| Experimental: mHealth Model Arm<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Care of Heart Failure | questionnaire that assesses self care where higher scores mean better self-care factor correlations range from 0.25 to 0.76 | Change from Baseline, 3 months, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Promis 43v2.1 Health Profile Anxiety 6a | subscale of questionnaire that measures anxiety. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/max range is 39.1-82.7 | Change from Baseline, 3 months, and 6 months | 
| Promis 43v2.1 Health Profile Depression 6a | subscale of questionnaire that measures depression. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 38.4-80.3 | Change from Baseline, 3 months, and 6 months | 
| Promis 43v2.1 Health Profile Fatigue 6a | subscale of questionnaire that measures fatigue. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 33.4-76.8 | Change from Baseline, 3 months, and 6 months | 
| Promis 43v2.1 Health Profile Pain Interference 6a | subscale of questionnaire that measures pain. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 41.1-76.3 | Change from Baseline, 3 months, and 6 months | 
| Promis 43v2.1 Health Profile Physical Function 6b | subscale of questionnaire that measures physical function. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 21.6-58.7 | Change from Baseline, 3 months, and 6 months | 
| Promis 43v2.1 Health Profile Sleep disturbance 6a | subscale of questionnaire that measures sleep disturbance. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population Min/Max Range 31.7-76.1 | Change from Baseline, 3 months, and 6 months | 
| Promis 43v2.1 Health Profile Ability to participate in social roles and activities 6a | subscale of questionnaire that measures the ability to participate in social roles and activities . Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max Range 26.7-65 | Change from Baseline, 3 months, and 6 months | 
| Promis 43v2.1 Health Profile PROMIS Pain Intensity item (Global07) | subscale of questionnaire that measures pain intensite. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 0-10 | Change from Baseline, 3 months, and 6 months | 
| Medical Outcomes Study MOS Health Distress Scale | questionnaire assesses psychological impact/health distress | Change from Baseline, 3 months, and 6 months | 
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) | questionnaire to assess quality of life. Scoring for the MLHFQ ranges from 0 to 105, the higher the score the more affected, over the past 4 months, the individual is by their heart failure. | Change from Baseline to 6 months |