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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Center for Disability Services, New York

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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