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

Chronic Conditions, Multiple Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05240534
• Other study ID #: 2020-0984
• Secondary ID: A195000Protocol
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 29, 2022
• Est. completion date: April 2027

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 502
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Conditions, Multiple
• Chronic Disease
• Disease
• Multiple Chronic Conditions

Intervention

Behavioral:
• ET-Text (Laptop)
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.
• ET-Voice (Smart System)
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.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in NIH Toolbox Loneliness Survey scores	NIH Toolbox Loneliness Survey is a self-report measure that assesses perceptions of loneliness. Participants rate items on a 5-point scale, with options ranging from never (1) to always (5). This creates a raw score, which is then converted to a t-score, with higher scores indicating greater levels of loneliness.	Baseline, 6, 12, 18 months
Other	ElderTree usefulness	This is a 9 item scale created for the study to assess the usefulness 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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in falls	The number of falls in the last 6 months	Baseline, 6, 12, 18 months
Secondary	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