A Structured Education Program for Children With Diabetes
A Structured Education Program for Children With Diabetes
The trial involved young people with T1DM and family members in 28 English pediatric diabetes clinics (randomly assigned at clinic level to intervention or control) in London, South East England, and the Midlands. Clinics eligible to participate were staffed by at least one pediatrician and pediatric nurse with an interest in diabetes. Other inclusion criteria included not running a group education program at time of recruitment and not participating in a similar pediatric diabetes trial within the past 12 months. It was approved by the University College London (UCL)/UCLH Research Ethics Committee (REC) reference number 07/HO714/112. Site-specific approval was granted at each site. Three hundred and sixty-two young people were recruited to the study. Inclusion criteria included: diagnosis with a duration ≥12 months; mean 12-month HbA1c of 8.5 or above; aged 8–16 years. Clinical staff identified eligible young people from their patient list. Researchers sent letters and information sheets to these young people and their parents or carers inviting them to participate in the research and to speak to a researcher at their next clinical appointment. Recruitment was primarily carried out by members of the process evaluation team who attended clinics at which eligible young people had an appointment. Signed consent forms were collected from parents and children wishing to participate.
The primary outcome measure was venous HbA1c at 12 and 24 months. Secondary outcomes included: knowledge, skills and responsibilities associated with diabetes management; emotional and behavioral adjustment; quality of life. Two staff members from each intervention site clinical team participated in the 2 days CASCADE training program. These site educators then took responsibility for organizing the modules at their clinics and delivering the intervention.
The extensive and integral process evaluation was designed to enable an understanding of the implementation of CASCADE and examination of the interaction of causal mechanisms and contextual factors that may be determinants of the intervention's success or failure, as assessed by the trial. Given that the trial found no evidence of benefits on venous HbA1c at 12 and 24 months and little evidence of benefits on secondary outcomes, the focus of this paper is to use the findings of the process evaluation to suggest how future structured education may be more effectively implemented.
Cascade Trial Summary
The trial involved young people with T1DM and family members in 28 English pediatric diabetes clinics (randomly assigned at clinic level to intervention or control) in London, South East England, and the Midlands. Clinics eligible to participate were staffed by at least one pediatrician and pediatric nurse with an interest in diabetes. Other inclusion criteria included not running a group education program at time of recruitment and not participating in a similar pediatric diabetes trial within the past 12 months. It was approved by the University College London (UCL)/UCLH Research Ethics Committee (REC) reference number 07/HO714/112. Site-specific approval was granted at each site. Three hundred and sixty-two young people were recruited to the study. Inclusion criteria included: diagnosis with a duration ≥12 months; mean 12-month HbA1c of 8.5 or above; aged 8–16 years. Clinical staff identified eligible young people from their patient list. Researchers sent letters and information sheets to these young people and their parents or carers inviting them to participate in the research and to speak to a researcher at their next clinical appointment. Recruitment was primarily carried out by members of the process evaluation team who attended clinics at which eligible young people had an appointment. Signed consent forms were collected from parents and children wishing to participate.
The primary outcome measure was venous HbA1c at 12 and 24 months. Secondary outcomes included: knowledge, skills and responsibilities associated with diabetes management; emotional and behavioral adjustment; quality of life. Two staff members from each intervention site clinical team participated in the 2 days CASCADE training program. These site educators then took responsibility for organizing the modules at their clinics and delivering the intervention.
The extensive and integral process evaluation was designed to enable an understanding of the implementation of CASCADE and examination of the interaction of causal mechanisms and contextual factors that may be determinants of the intervention's success or failure, as assessed by the trial. Given that the trial found no evidence of benefits on venous HbA1c at 12 and 24 months and little evidence of benefits on secondary outcomes, the focus of this paper is to use the findings of the process evaluation to suggest how future structured education may be more effectively implemented.
Source...