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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jennifer Stinson, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01477437
First received: November 17, 2011
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Hemophilia A
Other: Teens Taking Charge: Managing Hemophilia Online- Online self-management intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Development and Evaluation of an Internet-based Educational Program to Promote Self- Management for Teens With Hemophilia

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Disease-specific knowledge gained [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Disease-specific knowledge gained [ Time Frame: Immediately post-intervention - 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Health-related Quality of Life (HRQL) [ Time Frame: Baseline and immediately post-intervention - 8 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and immediately post-intervention - 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and immediately post-intervention - 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and immediately post-intervention - 8 weeks ] [ Designated as safety issue: No ]
    Will be measured in the intervention group only using the HEI-Q (Health Information Impact Questionnaire)


Enrollment: 29
Study Start Date: November 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention (experimental) Group Other: Teens Taking Charge: Managing Hemophilia Online- Online self-management intervention
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.
No Intervention: Control group

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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477437

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Jennifer Stinson, PhD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Jennifer Stinson, Clinical Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01477437     History of Changes
Other Study ID Numbers: 1000023483
Study First Received: November 17, 2011
Last Updated: August 19, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
teens
adolescents
Internet intervention
Hemophilia

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on October 01, 2014