Mobility Opportunities Via Education/Experience (MOVE): Healthcare Impact Assessment

May 8, 2023 updated by: Center for Disability Services, New York
The purpose of this study is to determine whether participation in the Mobility Opportunities Via Education (MOVE) program is associated with reduced use of healthcare for individuals with developmental disabilities.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine whether participation in the Mobility Opportunities Via Education (MOVE) program is associated with reduced use of healthcare for individuals with developmental disabilities. The investigators will compare healthcare "events" and healthcare expenditures for children and adults during intervals of at least one year when the subjects were participating in the MOVE program versus intervals of at least one year when the same individuals were not participating in the MOVE program based on health insurance records (i.e. Medicaid). Healthcare events are those which required professional medical services (associated with International Classification of Disease (ICD-XX) codes) or prescription medications. Healthcare events and healthcare expenditures will be reviewed from healthcare records obtained by Medicaid, Medicare, or private insurers and data will be compared between intervals.

Study Type

Observational

Enrollment (Anticipated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children and adults with developmental disabilities who participated in the MOVE program for at least one year pre-COVID and are participating in the MOVE program post-COVID, but who did not participate in the MOVE program during COVID.

Description

CHILDREN: Inclusion Criteria

  • Males and females 5-21 years old.
  • Participated in the MOVE program pre-COVID and post-COVID.
  • Did not participate for at least 4 months in the MOVE program during COVID.
  • Has a healthcare payor(s) who makes healthcare records available upon request.
  • Subjects whose legal guardians are willing to give informed consent to obtain and review healthcare records from the subject's primary (and secondary, if applicable) payors.

CHILDREN: Exclusion Criteria

  • Subjects who did not participate in the MOVE program through the duration of Interval #1 and Interval #3.
  • Subjects whose legal guardians are unwilling to cooperate with the requests to obtain and review healthcare records and expenditures from the subject's primary (and secondary, if applicable) payors.

ADULTS: Inclusion Criteria

  • Males and females 22-65 years old.
  • Participated in the MOVE program during Interval #1 and Interval #3.
  • Did not participate for at least 4 months in the MOVE program during Interval #2.
  • Has a healthcare payor(s) who makes healthcare records available upon request.
  • Subjects who are willing to give informed consent and/or subjects' legal guardians who are willing to give informed assent to obtain and review healthcare records from the subject's primary (and secondary, if applicable) payors.

ADULTS: Exclusion Criteria

  • Subjects who did not participate in the MOVE program through the duration of Interval #1 and Interval #3.
  • Subjects who are unwilling to give informed consent and/or subjects' legal guardians who are unwilling to give informed assent to cooperate with the requests to obtain and review healthcare records and expenditures from the subject's primary (and secondary, if applicable) payors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children in MOVE Program
Children 5-12 years old who participated in the MOVE program for at least 12 continuous months prior to March 1, 2020 and again for at least 12 continuous months after August 2021.
Other: MOVE Program
Mobility Opportunities Via Education functional therapy program.
Adults in MOVE Program
Adults 22-65 years old who participated in the MOVE program for at least 12 continuous months prior to March 1, 2020 and again for at least 12 continuous months after August 2021.
Other: MOVE Program
Mobility Opportunities Via Education functional therapy program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sum of Disability Adjusted Life Years
Time Frame: March 1, 2019 - April 30, 2023
Healthcare events will be reviewed from the insurance record. International Classification of Disease (ICD) codes will be use to convert the healthcare event to disability adjusted life years. The sum of all disability adjusted life years will be calculated.
March 1, 2019 - April 30, 2023
Number of Healthcare Events
Time Frame: March 1, 2019 - April 30, 2023
Healthcare events will be reviewed from the insurance record. The number of visits for professional healthcare will be determined.
March 1, 2019 - April 30, 2023
Cost of Healthcare Events
Time Frame: March 1, 2019 - April 30, 2023
Healthcare events will be reviewed from the insurance record and total costs associated with healthcare utilization will be determined.
March 1, 2019 - April 30, 2023
Cost of Medication Use
Time Frame: March 1, 2019 - April 30, 2023
Insurance records will be reviewed and the cost of medication used will be determined.
March 1, 2019 - April 30, 2023
Hip Range of Motion (Degrees)
Time Frame: March 1, 2019 - April 30, 2023
From the Mobility Opportunities Via Education (MOVE) program records, hip range of motion (in degrees) will be determined.
March 1, 2019 - April 30, 2023
PedsQL Quality of Life Scale Score
Time Frame: March 1, 2019 - April 30, 2023
From the Mobility Opportunities Via Education (MOVE) program records, the Pediatric Quality of Life Inventory (PedsQL) outcome instrument will be used to determine quality of life. The PedsQL is comprised of 7 questions with each question scored on a scale of 0-4. Higher scores indicate a higher quality of life.
March 1, 2019 - April 30, 2023
Top Down Motor Milestone Test Score
Time Frame: March 1, 2019 - April 30, 2023
From the Mobility Opportunities Via Education (MOVE) program records, the Top Down Motor Milestone (TDMMT) score will be determined as an assessment of function
March 1, 2019 - April 30, 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Disability Services, New York

Investigators

  • Principal Investigator: Eric H Ledet, Ph.D., Center for Disability Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2023

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 21-003 Rev. B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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