A multisite trial of a clinic-integrated intervention for promoting family management of pediatric type 1 diabetes: feasibility and design.
The feasibility of a family-based clinic-integrated behavioral intervention to improve family management of type 1 diabetes was evaluated. In each of four clinical sites, 30-32 families (a total of 122) were randomized to intervention or usual care comparison groups. The WE*CAN intervention, based on family problem-solving methods, was delivered during three routine clinic visits by trained 'Health Advisors'. Of eligible families across the four sites, 83% agreed to participate, of whom 96% completed the baseline, mid-term, and postintervention assessments. Families participated in an average of 2.85 intervention sessions over an 8-month period. The intervention was integrated into the clinic setting without impairing clinic flow and was implemented with fidelity and consistency across sites by trained non-professionals. The findings provide evidence of the feasibility of conducting a multisite trial to evaluate the effects of a clinic-integrated problem-solving intervention to improve family management. Many lessons were learned that provide guidance for recruitment, measurement, and intervention for the larger clinical trial.
Nansel
Tonja R
TR
Division of Epidemiology, Statistics and Prevention Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, DHHS, Bethesda, MD, USA. nanselt@mail.nih.gov
Anderson
Barbara J
BJ
Laffel
Lori M B
LM
Simons-Morton
Bruce G
BG
Weissberg-Benchell
Jill
J
Wysocki
Tim
T
Iannotti
Ronald J
RJ
Holmbeck
Grayson N
GN
Hood
Korey K
KK
Lochrie
Amanda S
AS
D000293:Adolescent; D015190:Blood Glucose Self-Monitoring; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000453:epidemiology / Q000628:therapy*; D004032:Diet; D019468:Disease Management; D015444:Exercise; D005240:Feasibility Studies; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D007328:Insulin / Q000008:administration & dosage; D007407:Interviews as Topic; D017063:Outcome Assessment, Health Care; D010287:Parent-Child Relations; D017060:Patient Satisfaction; D018579:Patient Selection; D010865:Pilot Projects; D011340:Problem Solving; D014481:United States / Q000453:epidemiology
D007004:Hypoglycemic Agents; D007328:Insulin