An Online Health Tool About Down Syndrome: Down Syndrome Clinic to You (DSC2U)
Down Syndrome
About this trial
This is an interventional health services research trial for Down Syndrome focused on measuring Online Health Tool, Health evaluations, Celiac Screen, Sleep Study, Thyroid Test, Audiogram, Ophthalmology evaluation, Healthcare outcomes survey, Experience survey
Eligibility Criteria
Potential eligible participants were directed to the study website (www.dsc2u.org) for the eligibility screening questionnaire in English and Spanish and online consent. After selecting a language preference (English or Spanish), in addition to questions about the child's or dependent's biological sex, race and ethnicity, the eligibility screening questions included:
- Do you have a child or dependent with DS?
- Is your child or dependent 1 year or older?
- When is your child's next annual well visit ("PCP visit")?
- Does your child or dependent currently receive care at a DS specialty clinic? (If the child or dependent was actively followed in a DS specialty clinic, even one out of state. For example, a family from Arizona who travels to Texas each year for their child to be seen in a DS specialty clinic would be ineligible)
Inclusion Criteria:
- If you have a child or dependent with Down syndrome (DS)
- If your child or dependent is 1 year or older
- If your child or dependent is does not receive care at a DS specialty clinic
Exclusion Criteria:
- If your child or dependent does receive care at a DS specialty clinic
- If your child or dependent is under 1 year old
- If your child or dependent has a PCP that is already involved in the study
DS occurs naturally and proportionally in all races and ethnicities, so the study's population estimates were proportional to the racial/ethnic distribution of the U.S. population, as reported in the 2010 U.S. Census. To achieve commensurate representation in the study, the investigators applied a quota system in offering enrollment using the race and ethnicity of the individual with DS (not the caregiver).
The investigators' plan was to enroll participants such that there were: no more than 144 white individuals with DS, no fewer than 25 Hispanic or Latino/Latina individuals with DS, and no fewer than 20 black individuals with DS. The team also planned to enroll no more than 120 individuals with DS of one sex.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention Group
Control Group
The participants randomized to the intervention group completed the DSC2U questionnaire, and received online access to a personalized Caregiver Checklist and PCP plan. Caregivers were encouraged to share and discuss the PCP plan at their next wellness visit with the PCPs.
The participants randomized to the control group, received usual care for 7 months, after their scheduled PCP appointment. They did not receive DSC2U during these 7 months, but did receive the online, personalized health assessment tool (DSC2U) at the end of the 7 months, after the primary and secondary outcomes were measured.