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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05862662
• Other study ID #: 21-003 Rev. B
• Status: Recruiting
• Start date: April 3, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Center for Disability Services, New York
• Contact: Eric H Ledet, Ph.D.
• Phone: 5184375584
• Email: eric.ledet[@]cfdsny.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Health Care Utilization
• Quality of Life

Intervention

Other:
• MOVE Program
Mobility Opportunities Via Education functional therapy program.

Locations

Country	Name	City	State
United States	Center for Disability Services	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Center for Disability Services, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Cost of Medication Use	Insurance records will be reviewed and the cost of medication used will be determined.	March 1, 2019 - April 30, 2023
Primary	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
Primary	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
Primary	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