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Completed

NCT Number: NCT01477437

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

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Teens Taking Charge: Managing Hemophilia Online- Online self-management intervention

Other

The content will be delivered on a password-protected website, as part of the "About Kids Health" interface developed and maintained at the Hospital for Sick Children, Toronto, Canada. The website has been developed as eight discrete educational modules for adolescents. Each module takes approximately 30 to 45 minutes to complete. Content has been written and reviewed by experts from comprehensive hemophilia care clinics across Canada (physicians, nurses, physiotherapists and social workers) and edited by a medical writer to ensure that it is written at the suggested grade 6 reading level for patient education materials. Content has been written in English and will be translated into French prior to program launch. The format is geared towards adolescents and includes narratives with video components and interactive illustrations. In addition, each module will have quiz questions with real-time feedback to promote interactivity and knowledge retention.

Primary outcomes

  1. Disease-specific knowledge gained

    Time frame: Baseline

    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.

  2. Disease-specific knowledge gained

    Time frame: 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 outcomes

  1. Health-related Quality of Life (HRQL)

    Time frame: 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

  2. Self-efficacy (Generalised Self-Efficacy-Sherer Scale)

    Time frame: 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.

  3. Preparedness for Transition

    Time frame: 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

  4. Impact of the program

    Time frame: Baseline and immediately post-intervention - 8 weeks

    Will be measured in the intervention group only using the HEI-Q (Health Information Impact Questionnaire)

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Development and Evaluation of an Internet-based Educational Program to Promote Self- Management for Teens With Hemophilia

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 22, 2011
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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