Quality of LifeNCT05862662
Mobility Opportunities Via Education/Experience (MOVE): Healthcare Impact Assessment
An observational study of Quality of Life and Health Care Utilization, run by Center for Disability Services, New York at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Quality of Life, Health Care Utilization
- What is being tested?
- MOVE Program
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center for Disability Services
Albany, New York, 12208
Eric H Ledet, Ph.D., 518-437-5584, eric.ledet@cfdsny.org
Rebecca Levy, MS, levyr2@rpi.edu
About this study
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.
Read the 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.
- Conditions
- Quality of Life, Health Care Utilization
- Being tested
- MOVE Program
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVE ProgramOther
Mobility Opportunities Via Education functional therapy program.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: MOVE Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: March 1, 2019 - April 30, 2023
Cost of Medication Use
Insurance records will be reviewed and the cost of medication used will be determined.
Measured: 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.
Measured: 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.
Measured: 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
Measured: March 1, 2019 - April 30, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start3 Apr 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Disability Services, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric H Ledet, Ph.D., Principal investigator, Center for Disability Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862662
- Sponsor's protocol ID
- 21-003 Rev. B
- Status last verified
- May 2023
- First submitted
- 13 Apr 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobility Opportunities Via Education/Experience (MOVE): Healthcare Impact Assessment
- ClinicalTrials.gov ID
- NCT05862662
- Acronym / sponsor ID
- 21-003 Rev. B
- Conditions
- Quality of Life, Health Care Utilization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Center for Disability Services, New YorkUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children in MOVE Program | – | Other: MOVE ProgramChildren 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. |
| Adults in MOVE Program | – | Other: MOVE ProgramAdults 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. |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOVE ProgramMobility Opportunities Via Education functional therapy program. | Other | Adults in MOVE Program, Children in MOVE Program |
Primary outcome
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.
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.
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.
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.
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.
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric H Ledet, Ph.D. principal investigator
Center for Disability Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Health Care Utilization, run by Center for Disability Services, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric H Ledet, Ph.D. (5184375584, eric.ledet@cfdsny.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of Disability Adjusted Life Years (time frame: March 1, 2019 - April 30, 2023). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.