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The Long-term Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Medicare Outcomes

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03952728
Enrollment
2796
Registered
2019-05-16
Start date
2016-12-19
Completion date
2022-06-30
Last updated
2022-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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.

Interventions

BEHAVIORALIntensive lifestyle intervention

Lifestyle intervention focused on weight loss through diet and physical activity

Behavioral intervention focused on diabetes support and education

Sponsors

University of Southern California
CollaboratorOTHER
Wake Forest University
CollaboratorOTHER
University of Minnesota
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Total inpatient (general hospital/acute care) discharges12-yearsThis is based on patient-level HEDIS specifications.
Medicare Part D Prescription Drug Fill Count12-yearsDerived measure indicating number of 30-day supply equivalents in each year.
Total number of emergency department visits12-yearsThis is based on patient-level HEDIS specifications.
Total inpatient (general hospital/acute care) days12-yearsThis is based on patient-level HEDIS specifications.

Secondary

MeasureTime frameDescription
Total Medicare spending12-yearsSums Medicare payments across service use categories
Medicare inpatient payments12-yearsPatient-level inpatient payments
Medicare Part D drug payments12-yearsPart D plan payments for covered drugs in a given year
Medicare Part D drug costs12-yearsGross drug costs for all Part D drugs for a given year
Medicare outpatient visits12-yearsBased on patient-level HEDIS specifications
Medicare hospital outpatient payments12-yearsBased on Medicare records
Medicare Part B physician payments12-yearsBased on Medicare records
Medicare Skilled Nursing Facility payments12-yearsBased on Medicare records

Other

MeasureTime frameDescription
Hospital readmissions12-yearsBased on HEDIS specifications
Originally eligible for Medicare due to End Stage Renal Disease (ESRD)12-yearsThis is based on Original Reason for Entitlement field in Medicare Beneficiary Summary File
Originally eligible for Medicare through Disability Insurance Benefits12-yearsThis is based on Original Reason for Entitlement field in Medicare Beneficiary Summary File
Inpatient medicine discharges12-yearsBased on patient-level HEDIS specifications
Inpatient surgical discharges12-yearsBased on patient-level HEDIS specifications
Inpatient medicine days12-yearsBased on patient-level HEDIS specifications
Inpatient surgical days12-yearsBased on patient-level HEDIS specifications
Medicare Dialysis Payments12-yearsBased on Medicare records
Medicare Durable Medical Equipment payments12-yearsBased on Medicare records
Medicare Imaging + Test payments12-yearsBased on Medicare records
Originally eligible for Medicare through Old Age and Survivor's Insurance12-yearsThis is based on Original Reason for Entitlement field in Medicare Beneficiary Summary File

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026