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Factors that influence parental attitudes toward enrollment in type 1 diabetes trials
Daniela L Buscariollo1, Mario A Davidson, Margo Black
1Department of Pediatrics, Ian Burr Division of Endocrinology and Diabetes, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.
Insights
Parental willingness to enroll children in type 1 diabetes clinical trials (T1DCTs) is moderate but influenced by trial design. Effective communication addressing concerns like placebo use is key to increasing participation.
Area of Science:
- Pediatric Endocrinology
- Clinical Trial Recruitment
- Patient Engagement
Background:
- Type 1 diabetes clinical trials (T1DCTs) are crucial for advancing treatment.
- Understanding parental attitudes is essential for successful trial recruitment.
Purpose of the Study:
- To evaluate parental attitudes toward T1DCTs.
- To identify factors influencing enrollment willingness for children with and without diabetes.
Main Methods:
- A cross-sectional survey was conducted among parents of children with type 1 diabetes.
- Data collected at an academic clinic and a diabetes educational event.
Main Results:
- 76% of parents were aware of T1DCTs; 47% were willing to enroll children with diabetes versus 36% without.
- Only 18% recalled being asked to enroll, and less than 30% were comfortable with placebo use.
- Healthcare provider trust and comfort with proxy consent significantly predicted willingness.
Conclusions:
- Parental willingness for T1DCT enrollment is moderate but impacted by trial methodologies.
- Improved communication addressing parental concerns (e.g., placebo, "guinea pig" fears) may enhance participation.
- Low recall of being asked to participate suggests a communication gap.
Aims:
To assess parental attitudes towards type 1 diabetes clinical trials (T1DCTs) and factors that impact willingness to enroll their children with and without diabetes.
Methods:
A cross-sectional survey of parents of children with type 1 diabetes was administered at an academic clinic and a diabetes educational event.
Results:
Survey response rate was 36%. Of 166 participating parents, 76% were aware of T1DCTs. More parents reported willingness to enroll children with diabetes (47%) than unaffected children (36%). Only 18% recalled being asked to enroll their children, and of these, 60% agreed to enroll at least some of those times. Less than 30% were comfortable with placebos. Factors predicting willingness to enroll children with diabetes included healthcare provider trust, comfort with consent by proxy, low fear of child being a "guinea pig," and comfort with placebo. Factors predicting willingness to enroll unaffected children were provider trust, comfort with consent by proxy, comfort with placebo, and perceived ease of understanding T1DCT information.
Conclusions:
Parents report moderate willingness to enroll children in T1DCTs. Willingness is diminished by common trial methodologies. Although most parents recalled receiving trial-related information, significantly fewer recalled being asked to participate. Efforts to optimize effective communication around identified areas of parental concern may increase T1DCT participation.
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