Health Education Clinical Trial
Official title:
Living Well With a Disability Curriculum Adaptation Evaluation Plan
NCT number | NCT03447119 |
Other study ID # | H18234 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 24, 2018 |
Est. completion date | January 15, 2022 |
Verified date | September 2023 |
Source | Georgia Southern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this proposal is to implement a joint project with Georgia Southern University and the Effingham County Navigator Team to improve the quality of life of families with a child with a disability in southeast Georgia. The final outcome of this project will be a new curriculum, Living Well Together, which builds on a previous implementation of the Living Well with a Disability curriculum in Bulloch County.
Status | Completed |
Enrollment | 39 |
Est. completion date | January 15, 2022 |
Est. primary completion date | January 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years and older |
Eligibility | Inclusion Criteria Families of with a child (3-50) with any developmental disability Exclusion Criteria Family and child are unable to follow directions and participate in curriculum activities. |
Country | Name | City | State |
---|---|---|---|
United States | B and B Care Services | Springfield | Georgia |
Lead Sponsor | Collaborator |
---|---|
Georgia Southern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Global Health | Patient Reported Outcomes Measurement Information System Parent Proxy scale v 1.0
Global Health Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Global Health (PROMIS PGH-7) measures general health, quality of life, physical health, mental health, feeling sad, social health (fun with friends), and parents listening to ideas. Each item is measured on a likert scale from 1 (never) to 5 (always). There is one item for each subscale listed above. A range for each subscale would be 1-5. Typically, results are reported as a whole so the range would be 7 to 35. For each subscale and the scale as a whole the higher the score, the better the global health. Subscales are summed to compute the total score. |
12 months | |
Secondary | Family Relationships | Patient Reported Outcomes Measurement Information System Parent Proxy scale v. 1.0
Family Relationships The Family Relationships subscale measures the importance and strength of the family unit perceived by the child in the past four weeks. Each item is measured on a Likert scale from 1 (never) to 4 (always). There are four items in this subscale. The reports are reported as a whole so the range is 4 to 16. The higher the score, the stronger the family relationships. Items are summed for the total score. |
12 months | |
Secondary | Life Satisfaction | Patient Reported Outcomes Measurement Information System Parent Proxy scale v 1.0 Life Satisfaction
The Life Satisfaction subscale measures quality of life in the past four weeks. Each item is measured on a Likert scale from 1 (not at all) to 5 (very much). There are eight items in this scale. The range for the whole subscale is 8-40. The higher the score, the better quality of life. Each item is summed for the total score. |
12 months | |
Secondary | Physical Activity | Patient Reported Outcomes Measurement Information System Parent Proxy scale v 1.0 Physical Activity
The Physical Activity subscale reports frequency and intensity of exercise of the child in the past week. Each item is measured on a Likert scale from 1 (no days) to 5 (6-7 days). There are eight items in this subscale. The total range is 8 (no exercise) to 40 (exercising regularly). The higher the score, the more physically active the individual is. The items are summed together for the score. |
12 months | |
Secondary | Psychological Stress Experiences | Patient Reported Outcomes Measurement Information System Parent Proxy scale v 1.0 Psychological Stress Experiences | 12 months | |
Secondary | Peer Relationships | Patient Reported Outcomes Measurement Information System Parent Proxy scale v 1.0 Peer Relationships
The Peer Relationships subscale measures the child's social activity in the last 7 days. Each item is measured on a Likert scale from 1 (never) to 5 (almost always). There are 7 items in the scale. The range is 7 (doesn't interact with friends) to 35 (very socially active). The higher the score the better the relationships. The items are summed together for a total score. |
12 months |
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