A Randomized, Controlled Trial of an Online Health Tool About Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 281
- 试验地点
- 2
- 主要终点
- Number of Participants With Indicated Evaluations That Were Completed or Recommended by the PCP
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Number of Participants With Indicated Evaluations That Were Completed or Recommended by the PCP
时间窗: 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.
次要结局
- Questionnaire: Caregiver Experience With the Intervention(2 weeks and 7 months after their scheduled PCP visit and with the intervention)
- Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up(Change from baseline at the 2-week follow-up time point)
- Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up(7-month follow-up survey)
- PCP Experience With the Intervention (Down Syndrome Clinic to You)(2 weeks after the scheduled PCP visit)
研究者
Brian G Skotko
Director, Down Syndrome Program
Massachusetts General Hospital