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

NCT01477437 | Completed

• 1 other identifier: 1000023483
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia A

Keywords

teens; adolescents; Internet intervention; Hemophilia

Outcome Measures

Primary Outcomes (2)

• Disease-specific knowledge gained

  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.

  Baseline

• Disease-specific knowledge gained

  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.

  Immediately post-intervention - 8 weeks

Secondary Outcomes (4)

• Health-related Quality of Life (HRQL)

  Baseline and immediately post-intervention - 8 weeks

• Self-efficacy (Generalised Self-Efficacy-Sherer Scale)

  Baseline and immediately post-intervention - 8 weeks

• Preparedness for Transition

  Baseline and immediately post-intervention - 8 weeks

• Impact of the program

  Baseline and immediately post-intervention - 8 weeks

Study Arms (2)

Intervention (experimental) Group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Interventions

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.

Intervention (experimental) Group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Related Publications (1)

• Breakey VR, Ignas DM, Warias AV, White M, Blanchette VS, Stinson JN. A pilot randomized control trial to evaluate the feasibility of an Internet-based self-management and transitional care program for youth with haemophilia. Haemophilia. 2014 Nov;20(6):784-93. doi: 10.1111/hae.12488. Epub 2014 Oct 14.

  PMID: 25311370 RESULT

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

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

Study Officials

• Jennifer Stinson, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scientist

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 22, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 3, 2018

Record last verified: 2017-12

Locations

CA (1)