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Completed

NCT Number: NCT03952728

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Intensive lifestyle intervention

Behavioral

Lifestyle intervention focused on weight loss through diet and physical activity

Diabetes Support and Education

Behavioral

Behavioral intervention focused on diabetes support and education

Primary outcomes

  1. Total inpatient (general hospital/acute care) discharges

    Time frame: 12-years

    This is based on patient-level HEDIS specifications.

  2. Total inpatient (general hospital/acute care) days

    Time frame: 12-years

    This is based on patient-level HEDIS specifications.

  3. Total number of emergency department visits

    Time frame: 12-years

    This is based on patient-level HEDIS specifications.

  4. Medicare Part D Prescription Drug Fill Count

    Time frame: 12-years

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

Secondary outcomes

  1. Total Medicare spending

    Time frame: 12-years

    Sums Medicare payments across service use categories

  2. Medicare inpatient payments

    Time frame: 12-years

    Patient-level inpatient payments

  3. Medicare Part D drug payments

    Time frame: 12-years

    Part D plan payments for covered drugs in a given year

  4. Medicare Part D drug costs

    Time frame: 12-years

    Gross drug costs for all Part D drugs for a given year

  5. Medicare outpatient visits

    Time frame: 12-years

    Based on patient-level HEDIS specifications

  6. Medicare hospital outpatient payments

    Time frame: 12-years

    Based on Medicare records

  7. Medicare Part B physician payments

    Time frame: 12-years

    Based on Medicare records

  8. Medicare Skilled Nursing Facility payments

    Time frame: 12-years

    Based on Medicare records

Other outcomes

  1. Originally eligible for Medicare through Old Age and Survivor's Insurance

    Time frame: 12-years

    This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File

  2. Originally eligible for Medicare through Disability Insurance Benefits

    Time frame: 12-years

    This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File

  3. Originally eligible for Medicare due to End Stage Renal Disease (ESRD)

    Time frame: 12-years

    This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File

  4. Hospital readmissions

    Time frame: 12-years

    Based on HEDIS specifications

  5. Inpatient medicine discharges

    Time frame: 12-years

    Based on patient-level HEDIS specifications

  6. Inpatient surgical discharges

    Time frame: 12-years

    Based on patient-level HEDIS specifications

  7. Inpatient medicine days

    Time frame: 12-years

    Based on patient-level HEDIS specifications

  8. Inpatient surgical days

    Time frame: 12-years

    Based on patient-level HEDIS specifications

  9. Medicare Dialysis Payments

    Time frame: 12-years

    Based on Medicare records

  10. Medicare Durable Medical Equipment payments

    Time frame: 12-years

    Based on Medicare records

  11. Medicare Imaging + Test payments

    Time frame: 12-years

    Based on Medicare records

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • University of Southern California
  • Wake Forest University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
May 16, 2019
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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