Impact of Integrated Pet Care on Glycemic Control and Diabetes Responsibility
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
The goal of this clinical trial is to learn if incorporating the structured care of a pet fish into a family-based diabetes self-care routine combined with communication skills training works to improve glycemic control, blood glucose monitoring frequency and blood glucose review in early adolescents with suboptimal control of type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 10-13 years (inclusive)
- •diagnosis of T1DM for at least one year
- •fluency in English or Spanish, (d) recent HbA1c value 7.5% - 14%
- •utilization of a CGM or glucometer that links with software to enable viewing and documentation in daily report including a section to enter "notes" (i.e. CGM/software, Dexcom/Clarity; Freestyle Libre/LibreView; AccuChek,OneTouch (glucometers)/MySugr)
- •current pet fish at home or willingness to obtain a pet fish if randomized to that intervention.
排除标准
- •clinical or laboratory characteristics suggestive of type 2 DM
- •involvement in foster care
- •dual-home living situation
- •severe psychiatric disorders
- •developmental delay or cognitive impairment that make it difficult to establish consistent diabetes and pet care behaviors
- •current participation in another study that may impact glycemic control
- •HbA1c >14% (because these individuals may need a more intensive intervention than this is intended to provide)
- •lack of a computer or compatible cell phone for uploading CGM or glucometer data.
结局指标
主要结局
Recruitment rate
时间窗: Baseline
Recruitment rate will be calculated as \[number of participants assenting\] divided by \[number who were invited\]
Fidelity to BGM (blood glucose monitoring) partnered with fish feeding
时间窗: 3 months
Fidelity to BGM partnered with fish feeding will be assessed by calculating the percentage of BG checks that were partnered with fish feeding.
Fidelity to weekly reviews partnered with fish tank maintenance
时间窗: 3 months
Fidelity to weekly reviews partnered with fish tank maintenance will be assessed by calculating the percentage of BG (blood glucose) reviews that were partnered with tank maintenance. The research team will review the data uploads on a weekly basis.
Retention rate
时间窗: 3 months
Retention rate will be calculated as \[number of participants who continue fish care tasks\] divided by \[number who were eligible upon completion of the baseline assessment\].
次要结局
- Number of blood glucose (BG) readings receiving parental review(Baseline, during intervention and post-intervention (monthly intervals, up to 6 months))
- Self Care Inventory (SCI) (modified)(Baseline, 3 months, 6 months)
- Time in Range (TIR)(Baseline, 3 months, 6 months)
- Blood glucose monitoring (BGM) frequency(Baseline, 3 months, 6 months)
- HbA1c (Hemoglobin A1C) level(Baseline, 3 months, 6 months)