NCT04227197

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

A Randomized, Controlled Trial of an Online Health Tool About Down Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Accepted

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.

Detailed description

Background: The overwhelming majority of people with Down syndrome do not have access to specialty clinics, a disparity resulting in delayed or missed diagnoses and significant untreated co-morbidities. To meet this critical gap in needs, the investigators created "Down Syndrome Clinic to You" (DSC2U), a novel, web-based tool created for caregivers of individuals with Down syndrome, which generates personalized recommendations for the caregiver and the patient's primary care provider (PCP). Methods: In a national, randomized controlled trial of 230 caregivers who had children or dependents with Down syndrome without access to a Down syndrome specialist, 117 were randomized to receive DSC2U and 113 to receive usual-care. The primary outcome was adherence to five health evaluations indicated by national guidelines for Down syndrome: celiac screen, sleep study, thyroid test, audiogram, and ophthalmology evaluation.

Conditions

• Down Syndrome

Interventions

Type	Name	Description
OTHER	Down Syndrome Clinic to You (DSC2U)	DSC2U is a web-based tool for families to get up-to-date, personalized health and wellness information, based on national guidelines and expert consensus, for a person with Down syndrome.

Timeline

• Start date: 2017-10-03
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2020-01-13
• Last updated: 2022-06-14
• Results posted: 2022-06-14

Locations

1 site across 1 country: United States