ElderTree Via a Voice Activated Device for Managing Chronic Health Conditions (NHLBI)

Study Overview
=================
Brief Summary
-----------------
Multiple chronic conditions (MCCs) are costly and pervasive among older adults. MCCs account for 90% of Medicare spending, and 65% of Medicare beneficiaries have 3 or more chronic conditions; 23% have 5 or more. MCCs are often addressed in primary care, where time pressures force a focus on medication and lab results rather than self-management skills. Patients often struggle with treatment adherence and the emotional and physical burdens of self-management and health tracking. Chronic conditions reduce quality of life (QOL) and increase loneliness, which exacerbate those conditions. The primary purpose of this study is to investigate whether a voice-based platform is better for delivering an electronic health intervention to older adults than a text/typing-based platform. We have an evidence-based electronic health intervention (Elder Tree, ET) that has been shown to improve quality of life, physical and socio-emotional health outcomes for older adults with multiple chronic conditions when delivered via a text/typing-based system. The current project would test whether such patients would benefit even more if ET were delivered via a voice-based system (vs. the text-based system) because they would use it more consistently. ET is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health.

Official Title
-----------------
Using Smart Displays to Implement Evidence-Based eHealth System for Older Adults With Multiple Chronic Conditions (NHLBI)

Conditions
-----------------
Chronic Conditions, Multiple

Intervention / Treatment
-----------------
* Behavioral: ET-Text (Laptop)
* Behavioral: ET-Voice (Smart System)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be ≥60 years old; Have medical record diagnoses of at least 5 chronic conditions of which at least 3 must come from the following: hypertension, hyperlipidemia, obesity, prediabetes or diabetes, or depression; Be willing to share medical record data about healthcare use (30-day hospital readmissions and ER, urgent care, primary care, and specialty care visits); Allow researchers to share information with the patient's primary care provider Exclusion Criteria: Require an interpreter Report no current psychotic disorder that would prevent participation Have no acute medical problem requiring immediate hospitalization Not report impairments preventing use of a computer or tablet (e.g. blind, deaf)

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group (ET-Text)<br>Participants will receive ElderTree on a laptop. | Behavioral: ET-Text (Laptop)<br>* ElderTree (ET) is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a walled garden free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. Like all CHESS systems, ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ET-Text arm will access ET on Laptop.<br>|
| Experimental: Experimental group (ET-Voice)<br>Participants will receive ElderTree on a smart system. | Behavioral: ET-Voice (Smart System)<br>* ElderTree (ET) is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a walled garden free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. Like all CHESS systems, ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ET-Voice arm will access ET on a smart speaker. Voice-activated devices can potentially be easy to use, even by those with limited dexterity or computer experience.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional health as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1. | Participant reported measure of overall health and level of physical disability. There are 4 questions with a possible score of 4-16. Lower scores indicate worse outcomes. | Baseline, 6, 12, 18 months | 
| Change in pain interference as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1. | Participant reported measure of pain interference, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes. | Baseline, 6, 12, 18 months | 
| Change in pain intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1. | Participant reported measure of pain intensity, this is a single question, with a possible score of 0 to 10. Higher scores indicate worse outcomes. | Baseline, 6, 12, 18 months | 
| Change in fatigue as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1. | Participant reported measure of fatigue, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes. | Baseline, 6, 12, 18 months | 
| Change in sleep as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1. | Participant reported measure of sleep disturbance, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes. | Baseline, 6, 12, 18 months | 
| Change in anxiety as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1. | Participant reported measure of anxiety, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes. | Baseline, 6, 12, 18 months | 
| Change in depression as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1. | Participant reported measure of depression, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes. | Baseline, 6, 12, 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in overall ElderTree use across the 12-month intervention | Amount of ElderTree use will be calculated by number of logons in the ET portal. | up to 12 months | 
| Change in healthcare use (primary care, specialist, urgent care, emergency room visits, and 30-day readmissions | Data will be collected from electronic health record. | Baseline, 6, 12, 18 months | 
| Change in health distress | Lorig Health Distress Scale is a self-reported measure. It has questions about how participant feel and how things have been during the past month. It is a 4 item scale. Each item can be score from 0-none of the time to 5- all the time. Higher scores corresponds to more amount of time the participant has been distressed about health (e.g.,discouraged, worried, fearful, frustrated by health problems). | Baseline, 6, 12, 18 months | 
| Change in function and disability | Late Life Function and Disability Instrument (FDI) evaluates self-reported difficulty a person has in performing activities of daily living tasks. There are 41 items with response options of none, a little, some, quite a lot, and cannot do. An additional eight items for participants who use a walking device. Scores range from 1-5 with higher scores indicating higher levels of functioning. | Baseline, 6, 12, 18 months | 
| Change in well-being | The World Health Organization- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental well being. The WHO-5 consists of five statements, which respondents rate from 'All of the time = 5' to 'At no time = 0'. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. | Baseline, 6, 12, 18 months | 
| Change in symptom distress | General Symptom Distress Scale & Bayliss Disease Burden Scale is a 16-item which assesses the extent of distress caused by physical symptoms. The higher scores indicating more symptom distress or burden. | Baseline, 6, 12, 18 months | 
| Change in falls | The number of falls in the last 6 months | Baseline, 6, 12, 18 months | 
| ElderTree ease of use | This is a 9 item scale created for the study to assess the ease of use of ElderTree. Participants rate items on a 4-point scale, with options ranging from not at all (1) to very much so (4), with higher scores indicating finding ElderTree useful. | 6, 12, 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Voice-activated smart technology, Older adults