In my efforts to find innovative and effective methods to improve pre-teen and teenage adherence in type 1 diabetes, I am always surveying the literature to find information. This month, a paper presented in the journal Pediatrics – Volume 129, No. 4, April 4, 2012, pages e866-e873 (the journal of the American Academy of Pediatrics) discusses “a clinic integrated behavioral intervention for families of youth with type 1 diabetes.” The journal Pediatrics requires an interesting introduction to all papers in regard to “what is known about the subject” and “what this study adds to the subject.” The authors: Nansel, Iannoti and Liu of the NIH respond as follows:
WHAT’S KNOWN ON THIS SUBJECT: Strategies to assist patients in achieving optimal chronic disease self-management are critical. The complex family and regimen issues surrounding pediatric type 1 diabetes management suggest the need to integrate such strategies into routine clinical care.
WHAT THIS STUDY ADDS: This study demonstrates the efficacy of a practical, low-intensity behavioral intervention delivered during routine care for improving glycemic outcomes. Findings indicate that the approach may offer a potential model for integrating medical and behavioral sciences to improve health care.
Clearly this is of major interest to all diabetes care teams caring for children and adolescents with type 1 diabetes. The authors hypothesized that the behavioral intervention group would have “less deterioration” than the control group.
What did the authors do?
The trial of 200 patients consisted of a multi-centered (Boston,Florida,Texas, andChicago) parallel group study of pediatric diabetes clinics with equal randomization throughout all centers. Participants included children from ages 9 to 14.5, diagnosed with type 1 diabetes for at least 3 months, minimum insulin dose of 0.5 units/kg/day for those diagnosed greater than 1 year, or 0.2 units/kg for those diagnosed less than 1 year, with a minimum of 2 shots /day or use of insulin pump therapy, hb A1c between 6-12 and no other major chronic diseases. OF NOTE, inclusion criteria also consisted of a “geographically stable home with telephone access,” two clinic visits in the past 12 months and no psychiatric illness in participating parents.
Families were randomly assigned to control or intervention groups and baseline assessments were conducted. One or both parents participated. Families were enrolled in the study for 2 years and questionnaires were routinely conducted at designated intervals. Parents and youth were compensated financially for completion of all assessments and youth were given $5 for each time glucose meters were available to download.
The “control” group received routine information and the intervention group received the “WE-CAN manage diabetes” intervention at each routine clinic visit. The intervention was grounded in major psychological theory and was designed to assist with families to improve diabetes management by facilitation of problem solving skills, communication skills, and responsibility sharing. Of note the intervention contact included a preparation phone call before clinic visits, in person contact during clinic visits, and follow-up telephone calls. Specially trained personnel delivered the psychological interventions. WE-CAN is an acronym as follows:
Acting on our Plan
What were the results?
Analyses included the use of two-sample t tests and predefined time intervals and linear-quadratic models to measure change in outcomes during the study.
- A significant (P=0.03) intervention effect on glycemic control was observed at the 24-month interval.
- The mixed effect model demonstrates significant (P<. 001) intervention by age interaction.
- Among participants from 12-14, a significant (P=. 009) effect on glycemic control occurred from baseline to 24-month interval.
- There was no effect among those aged 9-11.
What were the authors’ conclusions?
Based on the above results, the “clinic-integrated” behavioral intervention was effective in preventing deterioration of glycemic control in ages 12-14, but not in pre-adolescents. Other strategies will need to be investigated in the “emerging adolescent” group.
The study demonstrates that with increased contact with trained behavioral personnel, there is an improvement in glycemic control and adherence. However, the authors also note significant limitations. Despite the fact that the “intervention” was relatively simple in terms of complexity, increased staff is required and will need to be trained. With the changes in healthcare, will these services be covered by insurance plans? Will they be deemed important enough to include in our “routine care” of our patients?
The psychology team affiliated with the Diabetes Program at Children’s National Medical Center continues to conduct on-going studies in adherence and the relationship of diabetes control in differing age groups. Many of our patients are involved in these studies. Therefore, to determine practical means of delivering supportive behavioral therapies, we appreciate your participation in our ongoing studies. Clearly, psychological support in a critical necessity in the management of diabetes, as well as in any chronic disease model. The key is how to incorporate it relatively seamlessly in the routine office follow-up visit. Perhaps we will need to consider another model to effectively deliver both medical and psychosocial support on an ongoing basis.