NCT05862662

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

April 13, 2023

Last Update Submit

May 8, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • Sum of Disability Adjusted Life Years

    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

    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

    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

    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)

    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

    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

    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

Study Arms (2)

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

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

Interventions

Mobility Opportunities Via Education functional therapy program.

Adults in MOVE ProgramChildren in MOVE Program

Eligibility Criteria

Age5 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Disability Services

Albany, New York, 12208, United States

RECRUITING

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Eric H Ledet, Ph.D.

    Center for Disability Services

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric H Ledet, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2023

First Posted

May 17, 2023

Study Start

April 3, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 17, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations