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临床试验/NCT03952728
NCT03952728已完成不适用

The Long-term Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Medicare Eligibility, Health Care Use, and Health Care Spending

University of Minnesota0 个研究点目标入组 2,796 人开始时间: 2016年12月19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
2,796
主要终点
Total inpatient (general hospital/acute care) discharges

研究概览

简要总结

This study investigates whether an intensive lifestyle intervention for type 2 diabetes had long-term effects on Medicare enrollment, health care use, and health care spending.

详细描述

The Look AHEAD study tested whether participants with type 2 diabetes assigned to an intensive lifestyle intervention (ILI) for weight loss exhibited reductions in cardiovascular morbidity and mortality, relative to a control group receiving usual care and diabetes support and education. During the 12-year intervention period, the ILI led to persistent reductions in weight, waist circumference, and hemoglobin A1c and improvements in physical fitness. In addition, the ILI led to reductions in hospitalizations, hospital days, and prescription drug spending during the intervention period (through 2012). However, the longer-term effects (2012 and later) on health care use and spending remain unknown.

In an ongoing ancillary study, the researchers are investigating the effects of the ILI on economic outcomes, during and after the study. As a part of this study, the study team is linking consenting Look AHEAD participants to Medicare databases. The researchers will investigate the long-term effects of ILI on health care use and health care spending.

By 2012 nearly all Look AHEAD participants were eligible for Medicare due to age (over 65). To the extent that Look AHEAD participants developed severe disabilities, the participants may have gained Medicare eligibility earlier through enrollment in Social Security Disability Insurance (SSDI). Thus, the researchers will also test for differences in the Medicare enrollment channel between ILI and control group participants, specifically whether the groups enrolled through SSDI at different rates.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Look AHEAD participation: met age requirements and other criteria at time of study enrollment (as noted in Look AHEAD Research Group (2013))
  • Consented to administrative data linkages
  • Provided individual identifiers that could be linked with Medicare databases
  • Were successfully linked to Medicare data

排除标准

  • 未提供

结局指标

主要结局

Total inpatient (general hospital/acute care) discharges

时间窗: 12-years

This is based on patient-level HEDIS specifications.

Total number of emergency department visits

时间窗: 12-years

This is based on patient-level HEDIS specifications.

Medicare Part D Prescription Drug Fill Count

时间窗: 12-years

Derived measure indicating number of 30-day supply equivalents in each year.

Total inpatient (general hospital/acute care) days

时间窗: 12-years

This is based on patient-level HEDIS specifications.

次要结局

  • Total Medicare spending(12-years)
  • Medicare Part D drug costs(12-years)
  • Medicare outpatient visits(12-years)
  • Medicare inpatient payments(12-years)
  • Medicare Part D drug payments(12-years)
  • Medicare hospital outpatient payments(12-years)
  • Medicare Part B physician payments(12-years)
  • Medicare Skilled Nursing Facility payments(12-years)

研究者

申办方类型
Other
责任方
Sponsor

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