Internet-based Educational Program to Promote Self-Management for Teens With Hemophilia

Not Applicable

Completed

• Conditions: Hemophilia A

• Registration Number: NCT01477437
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

In summary, there is a clear need to improve knowledge and self-management skills in adolescents with hemophilia. To date, there are no published accounts of self-management programs for this population. Evidence from other chronic diseases that affects teens suggests that by developing an interactive Internet-based program, the investigators can meet the educational needs of adolescents with hemophilia and improve their ability to manage their hemophilia. In the long-term, improved self-management should result in a smoother and more successful transition to adult care and improve patient outcomes.

Detailed Description

The overall aim of this program of research is to develop and evaluate the "Teens Taking Charge: Managing Hemophilia Online" Internet intervention that will help adolescents with hemophilia to better understand and manage their disease independently. This program is modeled after Dr. Stinson's similar successful internet self-management program developed for youth with arthritis.

This program is being developed and evaluated using a sequential, phased approach. The first phase of this project has determined the self-management and transitional care needs of adolescents with hemophilia. Currently, in Phase 2A, we are developing the website with the content based on the findings from the Phase 1 needs assessment. We propose the current study to conduct usability testing (Phase 2B) to make sure it is easy to use and understand, and is efficient and satisfying to complete. Subsequently, we will assess the feasibility of the program and the outcomes from the use of the site in a randomized controlled trial (RCT) pilot study (Phase 3). This will enable us to determine an appropriate sample size for the future mixed controlled trial. Phases 2B and 3 are the focus of this proposal. Phase 4 will be a multicentre randomized controlled trial to assess outcomes for teens that complete the intervention as compared to those of an attention control group. This randomized controlled trial controlled trial will include all interested pediatric hemophilia treatment centres across Canada.

We hypothesize that adolescents with hemophilia who complete the "Teens Taking Charge: Managing Hemophilia Online" Internet intervention will demonstrate: increased hemophilia specific knowledge, increased self-efficacy, improved health-related quality of life (HRQL) and decreased stress prior to transition to adult health care.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2011-11-21
• Study First Posted: 2011-11-22
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-29
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• age 13-18
• diagnosis of mild, moderate or severe hemophilia A or B
• be able to speak and read English or French.
• must have access to the Internet at home

Exclusion Criteria

• cognitive impairments
• haematologist feels that they have a significant medical or psychiatric condition that will impact their participation
• don't have access to the internet.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disease-specific knowledge gained	Immediately post-intervention - 8 weeks	assessed by pre and post-assessment of the "Hemophilia Knowledge Questionnaire". This novel tool will be developed by investigators based on core content deemed important by hemophilia care providers and be reviewed for face validity by the Hemophilia Care Teams in both study centers and by a National panel of reviewers prior to administration.

Secondary Outcome Measures

Name	Time	Method
Health-related Quality of Life (HRQL)	Baseline and immediately post-intervention - 8 weeks	Assessed pre and post intervention using the CHOK-LAT (Canadian Hemophilia Outcomes- Kids' Life Assessment Tool). This 35 item tool was developed at the Hospital for Sick Children and has been shown to be reliable and valid in assessing HRQL in children and adolescents with hemophila
Self-efficacy (Generalised Self-Efficacy-Sherer Scale)	Baseline and immediately post-intervention - 8 weeks	This tool measures self efficacy. The 17-item scale was originally developed by Sherer and modified by Bosscher and Smit to include 12 items in three sub-scales (initiative, effort and persistence). This scale has been validated and found to be reliable in diverse populations. Although not validated specifically in adolescents, it has been used to study this population.
Preparedness for Transition	Baseline and immediately post-intervention - 8 weeks	Measured using questionnaire developed by the John Hopkins Adult Cystic Fibrosis Program in a survey analyzing patient attitudes towards transition. The questions from this questionnaire have already been used in transition studies focused adolescents with hemophilia
Impact of the program	Baseline and immediately post-intervention - 8 weeks	Will be measured in the intervention group only using the HEI-Q (Health Information Impact Questionnaire)

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada