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临床试验/NCT03255902
NCT03255902已完成不适用

Family Routine - Healthy Families

William Beaumont Hospitals0 个研究点目标入组 7 人开始时间: 2016年5月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
7
主要终点
Effect of Intervention on Evening Glucose Control.

研究概览

简要总结

The purpose of the proposed study, Family Routines - Healthy Families, is to examine the feasibility and acceptability of a parenting/family routine intervention program for parents of young children, ages 2-5, with type 1 diabetes.

详细描述

The intervention in Family Routines - Healthy Families contains an established and effective parent skills training curriculum called "The Incredible Years," uniquely integrated with a newly developed family evening routine component e.g., family dinner time and evening routine, to promote improved metabolic control. The investigator will assess outcomes during and at one week post intervention. Outcome measures will include family routine, specifically the time between the dinner and bedtime glucose check, parent bedtime decision making, and child overnight glucose control. In addition, parental quality of life and receptiveness to the intervention will be assessed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Self identification as primary care giver of child that fits following criteria:
  • Age 2 - 5 years
  • Diagnosis of Type 1 diabetes
  • Most recent Hemoglobin A1c (HbA1c) > 8.0
  • Child a patient of Pediatric Endocrinology, Beaumont Children's Hospital
  • English fluency

排除标准

  • Cognitively impaired
  • Does not meet inclusion criteria

研究组 & 干预措施

Families attending parenting classes

Experimental

Families attended 6 parenting sessions, filled out daily glucose screens, & questionnaires

干预措施: Parenting classes (Behavioral)

结局指标

主要结局

Effect of Intervention on Evening Glucose Control.

时间窗: After 6 weeks of classes

Number of families whose child achieved a decrease overnight between bedtime blood glucose level and morning fasting glucose level following intervention at 6 weeks.

次要结局

  • Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value(Pre intervention to 3 months post intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Donna Marvicsin

Nurse Practitioner, Pediatric Endocrinology

William Beaumont Hospitals

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