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
- 1
- 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
- •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
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.
研究组 & 干预措施
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.
干预措施: Down Syndrome Clinic to You (DSC2U) (Other)
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.
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
- Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up(7-month follow-up survey)
- 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)
- 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