MedPath

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

Not Applicable
Active, not recruiting
Conditions
Chronic Conditions, Multiple
Interventions
Behavioral: ET-Text (Laptop)
Behavioral: ET-Voice (Smart System)
Registration Number
NCT05240534
Lead Sponsor
University of Wisconsin, Madison
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
502
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control group (ET-Text)ET-Text (Laptop)Participants will receive ElderTree on a laptop.
Experimental group (ET-Voice)ET-Voice (Smart System)Participants will receive ElderTree on a smart system.
Primary Outcome Measures
NameTimeMethod
Change in functional health as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.Baseline, 6, 12, 18 months

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.

Change in anxiety as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.Baseline, 6, 12, 18 months

Participant reported measure of anxiety, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.

Change in pain interference as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.Baseline, 6, 12, 18 months

Participant reported measure of pain interference, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.

Change in pain intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.Baseline, 6, 12, 18 months

Participant reported measure of pain intensity, this is a single question, with a possible score of 0 to 10. Higher scores indicate worse outcomes.

Change in fatigue as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.Baseline, 6, 12, 18 months

Participant reported measure of fatigue, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.

Change in sleep as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.Baseline, 6, 12, 18 months

Participant reported measure of sleep disturbance, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.

Change in depression as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.Baseline, 6, 12, 18 months

Participant reported measure of depression, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.

Secondary Outcome Measures
NameTimeMethod
Change in overall ElderTree use across the 12-month interventionup to 12 months

Amount of ElderTree use will be calculated by number of logons in the ET portal.

Change in health distressBaseline, 6, 12, 18 months

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).

Change in fallsBaseline, 6, 12, 18 months

The number of falls in the last 6 months

Change in healthcare use (primary care, specialist, urgent care, emergency room visits, and 30-day readmissionsBaseline, 6, 12, 18 months

Data will be collected from electronic health record.

Change in well-beingBaseline, 6, 12, 18 months

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.

Change in symptom distressBaseline, 6, 12, 18 months

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.

Change in function and disabilityBaseline, 6, 12, 18 months

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.

ElderTree ease of use6, 12, 18 months

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.

Trial Locations

Locations (1)

University of Wisconsin

🇺🇸

Madison, Wisconsin, United States

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