Using Smart Displays to Implement Evidence-Based eHealth System for Older Adults With Multiple Chronic Conditions (NHLBI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 502
- 试验地点
- 2
- 主要终点
- Change in functional health as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Control group (ET-Text)
Participants will receive ElderTree on a laptop.
干预措施: ET-Text (Laptop) (Behavioral)
Experimental group (ET-Voice)
Participants will receive ElderTree on a smart system.
干预措施: ET-Voice (Smart System) (Behavioral)
结局指标
主要结局
Change in functional health as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
- Change in overall ElderTree use across the 12-month intervention(up to 12 months)
- Change in health distress(Baseline, 6, 12, 18 months)
- Change in falls(Baseline, 6, 12, 18 months)
- Change in healthcare use (primary care, specialist, urgent care, emergency room visits, and 30-day readmissions(Baseline, 6, 12, 18 months)
- Change in well-being(Baseline, 6, 12, 18 months)
- Change in symptom distress(Baseline, 6, 12, 18 months)
- Change in function and disability(Baseline, 6, 12, 18 months)
- ElderTree ease of use(6, 12, 18 months)