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Clinical Trials/NCT03952728
NCT03952728
Completed
Not Applicable

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 sites2,796 target enrollmentDecember 19, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
University of Minnesota
Enrollment
2796
Primary Endpoint
Total inpatient (general hospital/acute care) discharges
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 19, 2016
End Date
June 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Total inpatient (general hospital/acute care) discharges

Time Frame: 12-years

This is based on patient-level HEDIS specifications.

Total number of emergency department visits

Time Frame: 12-years

This is based on patient-level HEDIS specifications.

Medicare Part D Prescription Drug Fill Count

Time Frame: 12-years

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

Total inpatient (general hospital/acute care) days

Time Frame: 12-years

This is based on patient-level HEDIS specifications.

Secondary Outcomes

  • 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)

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