Feasibility Study Of a Randomized Control Trial To Evaluate An Internet-Based Self-Management Program For Adolescents With Hemophilia
Bibliographic record
Abstract
Abstract Introduction As 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. Aim To 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. Methods Adolescents, 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. Results 29 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. Conclusions This 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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.039 | 0.035 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.002 | 0.003 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.011 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".