N/A N=230 Randomized Health Services Research

An Online Health Tool About Down Syndrome: Down Syndrome Clinic to You

Down Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT04227197 ↗

Enrolled (actual)

230

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Number of Participants With Indicated Evaluations That Were Completed or Recommended by the PCP — 69; 79; 36; 31 participants — p=0.018

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Down Syndrome Clinic to You (DSC2U) (Other)
Age: Pediatric, Adult, Older Adult · 1+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Indicated Evaluations That Were Completed or Recommended by the PCP	69; 79; 36; 31; 10; 3	0.018 sig
SECONDARY Questionnaire: Caregiver Experience With the Intervention	91; 0; 5; 0; 5; 0	—
SECONDARY Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up	69.8; 71.2; -3.2; -2.3; 63.4; 62.9	0.468
SECONDARY Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up	69.8; 71.2; -2.3; 0.4; 63.4; 62.9	0.068
SECONDARY PCP Experience With the Intervention (Down Syndrome Clinic to You)	55; 25; 11; 3	—

Summary

The investigators conducted a national two-arm, randomized controlled trial of caregivers of individuals with DS to assess the efficacy of DSC2U in assuring adherence to evidence-based guidelines. The research plan was approved by the Partners Human Research Committee.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04227197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.