The Impact of Changing to a New Child- and Family-centered Outpatient Diabetes Clinic Focusing on Early Involvement of the Child With Diabetes, Training in Calmness Around Diabetes Management, Healthy Lifestyle, and Creating Peer-to-peer Networks
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Parental diabetes-related quality of life (T1DAL)
研究概览
简要总结
The goal of StenoChild is to strengthen the treatment of children under 10 years old with diabetes through a multi-component approach. This includes play-based methods, a focus on nutrition and mental health, and peer-to-peer programs that facilitate parental support and learning. The project has both a clinical and organizational dimension, as it aims to improve diabetes care and change practices and task organization at Steno Diabetes Center Copenhagen, SDCC.
详细描述
The investigators encourage families to engage in eating, exercising, playing, and storytelling together, leveraging children's natural inclination to learn through play. This approach allows healthcare providers (HCPs) and parents to gain insights into the child's perspective, improving communication.
The hypotheses are i) improved calmness during diabetes-related tasks with potential painful procedures such as shift of insulin infusions set and sensor will ease diabetes management and reduce parental distress; ii) improved structure and calmness around meals will ease diabetes management, reflected in interaction with insulin pumps; iii) the group and play-based approach will lead to healthier lifestyle changes compared to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion of children and their families
- •Inclusion Criteria:
- •Age 3-10 years
- •Followed at Steno Diabetes Center Copenhagen
排除标准
- •Severe psychiatric disease
- •Language barriers (Children not speaking Danish, Parents not speaking Danish or English)
研究组 & 干预措施
StenoChild intervention
See below, Families are randomized pragmatically based on their assigned HCP. Approximately 50% will attend a new clinic offering group-based, family-centered care (90-100 families); the rest receive standard care, with the intervention offered later in a waitlist design.
干预措施: Group consultations and peer-to-peer learning (Behavioral)
Standard Care
Families are randomized pragmatically based on their assigned HCP. Approximately 50% will attend a new clinic offering group-based, family-centered care (90-100 families); the rest receive standard care, with the intervention offered later in a waitlist design.
干预措施: Standard Care (in control arm) (Other)
结局指标
主要结局
Parental diabetes-related quality of life (T1DAL)
时间窗: From baseline to study end after one year
Change in Parental diabetes-related quality of life, measured by the questionnaire T1DAL in Danish. An increase in score indicates an improvement in parental diabetes-related quality of life.
Children's perception of clinical visits (MyHospitalVoice)
时间窗: From baseline to study end after one year
Change in Children's perception of clinical visits, measured by the questionnaire MyHospitalVoice in Danish. An increase in score indicates an improvement in perception of clinical visits-
次要结局
- Change in glycemic outcomes by CGM-derived metrics(From baseline to study end after one year)
- Change in glycemic outcomes measured by HbA1c(From baseline to study end after one year)
- Change in total daily dose of insulin per kg(From baseline to study end after one year)
- Change in the number of boluses registered per day(From baseline to study end after one year)
- Change in timing of boluses(From baseline to study end after one year)
- Change in carbohydrates/kg entered per day(From baseline to study end after one year)
- Change in infusion set wear-time(From baseline to study end after one year)
- Change in time in automated insulin delivery mode (AID) on the insulin pump system.(From baseline to study end after one year)
- Change in conflicts and problems with procedures(From baseline to study end after one year)
- Change in parental fear of hypoglycemia(From baseline to study end after one year)
- Change in BMI z-scores(From baseline to study end after one year)
- Participation in planned modules(From baseline to study end after one year)
研究者
Nanna Lind
Post doctoral researcher, PhD, RN
Steno Diabetes Center Copenhagen