Down Syndrome Clinic to You (DSC2U)
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|ClinicalTrials.gov Identifier: NCT04227197|
Recruitment Status : Completed
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Down Syndrome||Other: Down Syndrome Clinic to You (DSC2U)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Randomized, Controlled Trial of an Online Health Tool About Down Syndrome|
|Actual Study Start Date :||October 3, 2017|
|Actual Primary Completion Date :||May 15, 2019|
|Actual Study Completion Date :||May 15, 2019|
Experimental: Intervention 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.
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.
No Intervention: Control Group
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.
- Number of indicated evaluations that were completed or recommended by the PCP [ Time Frame: 7 months after the participant's scheduled PCP visit ]Adherence to the five health evaluations indicated by national guidelines for Down syndrome. The five health evaluations included: celiac screen, sleep study, thyroid test, audiogram, and ophthalmology evaluation.
- Caregiver experience with the PCP visit questionnaire [ Time Frame: 2 weeks, and 7 months after their scheduled PCP visit ]Measure the caregiver experience with the PCP using a 10-point Likert scale with "10" representing "most helpful" and "0" representing "least helpful."
- Quality of life outcomes for person with Down syndrome questionnaire [ Time Frame: 2 weeks, and 7 months after their scheduled PCP visit ]Ascertained through the six PedsQL 4.0 parent-proxy and PedsQL 2.0 Family Impact Module summary scores.
- PCP experience with the patient visit questionnaire [ Time Frame: 2 weeks after the scheduled PCP visit ]These measurements were gathered by self-administered mail survey
- PCP experience with DSC2U questionnaire [ Time Frame: 2 weeks after the scheduled PCP visit ]These measurements were gathered by self-administered mail survey, for the PCP's randomized to the intervention group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04227197
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|