Feasibility Study Of a Randomized Control Trial To Evaluate An Internet-Based Self-Management Program For Adolescents With Hemophilia
Journal Articles
Overview
Research
Identity
Additional Document Info
View All
Overview
abstract
AbstractIntroductionAs adolescents with hemophilia approach adulthood, they must assume responsibility for their health and management of their disease. An online self-management program was developed to support adolescents during this transition.AimTo determine the feasibility of studying the online educational program using a non-blind, randomized control trial(RCT) design in terms of 1)Study accrual and attrition rates, 2) willingness to be randomized 3) compliance with the program and completion of the outcome measures, and 4) satisfaction with the program.MethodsAdolescents, ages 13-18, were enrolled from three tertiary care centres in Canada in a pilot RCT (NCT01477437). After providing informed consent, adolescents were randomized to the intervention (8 week program with telephone coaching) or the control arm (no access, weekly telephone call as attention-strategy). Adolescents in both arms of the study were asked to complete pre- and post- outcome measures. Following completion of the program, quantitative analysis addressed the feasilibity measures and qualitative interviews were conducted to assess satisfaction.Results29 teens participated (intervention group, n=16, control group, n=13).Participants in the intervention arm spent an average of 50 minutes on the website per week completed the 8 modules in an average of 14 weeks (SD= 4.9). Among those randomized to the intervention, 2 participants dropped out of the study and 2 were lost to follow-up, resulting in an attrition rate of 25% (4/16). The control arm had a higher attrition rate of 54% (7/13) with 5 participants being lost to follow-up and 2 participants dropping out. For participants who completed the program, 17/18 (94%) completed the post-study outcome measures. Despite the study not being powered to assess efficacy, teens on the intervention arm showed significant improvement in disease-specific knowledge (p=0.004), self-efficacy (p=0.007) and transition preparedness (p=0.046) over time. There was a statistically significant improvement in the knowledge measure in the intervention group when compared to the control group (p=0.01). Overall, the teens found the website to be informative, comprehensive and easy to use and were satisfied with the program.ConclusionsThis feasibility study suggests benefit to the program and indicates a full scale RCT to be a reasonable next step with minor adjustments to the protocol. The higher than expected attrition rate in the control group, suggests the need to improve the strategies for maintaining participant engagement using a more active attention control group (static educational materials) in the design of this web-based intervention prior to a larger study to assess efficacy.Disclosures:Breakey: Baxter Bioscience: Research Funding.
