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临床试验/NCT03387735
NCT03387735已完成不适用

Heart-Related Multiple Chronic Conditions in Primary Care: Behavioral Technology

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 346 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
346
试验地点
2
主要终点
UCLA Loneliness Scale

研究概览

简要总结

Multiple chronic conditions are common and expensive among patients aged ≥65 and are associated with lower quality of life, poorer response to treatment, worse medical and psychiatric outcomes, higher mortality, and higher costs of care.

The primary purpose of this study is to conduct a randomized clinical trial (RCT) to examine the effects of ElderTree --a web-based intervention--on health outcomes and healthcare use among older adults with several chronic health conditions, such as diabetes, high blood pressure, high cholesterol, COPD, BMI over 30, congestive heart failure, chronic kidney disease, arrhythmia/atrial fibrillation, chronic pain, arthritis.

The investigator's hypothesis is that patients assigned to TAU+ElderTree will have better quality of life and fewer primary care visits than those assigned to TAU+Internet.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • are ≥65 years old
  • have been treated in the University of Wisconsin Health clinics for at least the previous 18 months with no plans to leave during the study period
  • have 3 or more of the following chronic conditions: hypertension, hyperlipidemia, diabetes, arthritis, BMI over 30, chronic kidney disease, congestive heart failure, arrhythmia/atrial fibrillation, pulmonary heart disease or pulmonary vascular disease, chronic pain, COPD
  • report no current psychotic disorder that would prevent participation
  • have no acute medical problem requiring immediate hospitalization
  • be able to read and sign the consent form in English
  • have no known terminal illness
  • be willing to share health-related study data and
  • Systolic and diastolic BP
  • pain score
  • lung function
  • health care utilization: number of ER visits, urgent care visits, primary care visits and specialty care visits
  • allow researchers to share information with their primary care physician

排除标准

  • 未提供

结局指标

主要结局

UCLA Loneliness Scale

时间窗: Baseline and 12-months

Loneliness is measured using the 8 items from the UCLA Loneliness Scale with the highest factor loadings among older adults. Scores ranged from 8 to 40. Higher scores indicate more loneliness.

PROMIS Global Health Measure Score

时间窗: Measured at baseline and 12 months

Quality of life is assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health measure. For consistency with other measures, the time frame has been modified to refer to the past 2 weeks. Scores are calculated using the HealthMeasures Scoring Service. Scores are a T-score metric with a mean of 50 and a standard deviation of 10 with a range of about 20 to 80. Higher scores indicate better quality of life.

Psychological Flourishing Scale

时间窗: Baseline and 12-months

Psychological well-being is assessed using the Psychological Flourishing Scale. The wording of items has been somewhat modified, including simplifying double-barreled items. For example, "I lead a purposeful and meaningful life" is shortened to "I lead a meaningful life." Scores are a sum of all items with a range from 8 to 40. Higher scores indicate a better well-being.

次要结局

  • Medication Adherence(Baseline and 12-months)
  • Symptom Distress(Baseline and 12-months)
  • Falls(Baseline and 12-months)
  • Falls Requiring Medical Attention(Baseline and 12-months)
  • Unhealthy Laboratory Scores(12-months)
  • Long-term Care(Baseline and 12-months)
  • Crisis Health Care Visits(Baseline and 12-months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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