Hemophilia ANCT01477437
Internet-based Educational Program to Promote Self-Management for Teens With Hemophilia
A study testing Teens Taking Charge: Managing Hemophilia Online- Online self-management intervention in people with Hemophilia A, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Teens Taking Charge: Managing Hemophilia Online- Online self-management intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of an 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.
Read the 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.
- Conditions
- Hemophilia A
- Being tested
- Teens Taking Charge: Managing Hemophilia Online- Online self-management intervention
- Keywords
- teens, adolescents, Internet intervention, Hemophilia
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teens Taking Charge: Managing Hemophilia Online- Online self-management interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (experimental) Group | Experimental | Not described Receives: Other: Teens Taking Charge: Managing Hemophilia Online- Online self-management intervention |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately post-intervention - 8 weeks
Secondary outcomes (4)
Health-related Quality of Life (HRQL)
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
Measured: Baseline and immediately post-intervention - 8 weeks
Self-efficacy (Generalised Self-Efficacy-Sherer Scale)
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.
Measured: Baseline and immediately post-intervention - 8 weeks
Preparedness for Transition
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
Measured: Baseline and immediately post-intervention - 8 weeks
Impact of the program
Will be measured in the intervention group only using the HEI-Q (Health Information Impact Questionnaire)
Measured: Baseline and immediately post-intervention - 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Stinson, The Hospital for Sick Children
- Investigators
- Jennifer Stinson, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477437
- Sponsor's protocol ID
- 1000023483
- Status last verified
- Dec 2017
- First submitted
- 17 Nov 2011
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25311370
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Internet-based Educational Program to Promote Self- Management for Teens With Hemophilia
- ClinicalTrials.gov ID
- NCT01477437
- Acronym / sponsor ID
- 1000023483
- Conditions
- Hemophilia A
- Keywords
- teens, adolescents, Internet intervention, Hemophilia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (experimental) Group | Experimental | Other: Teens Taking Charge: Managing Hemophilia Online- Online self-management intervention |
| Control group | No intervention | – |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teens Taking Charge: Managing Hemophilia Online- Online self-management interventionThe 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. | Other | Intervention (experimental) Group |
Primary outcome
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.
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.
4 secondary outcomes
Health-related Quality of Life (HRQL)
Time frame: Baseline and immediately post-intervention - 8 weeks
Self-efficacy (Generalised Self-Efficacy-Sherer Scale)
Time frame: Baseline and immediately post-intervention - 8 weeks
Preparedness for Transition
Time frame: Baseline and immediately post-intervention - 8 weeks
Impact of the program
Time frame: Baseline and immediately post-intervention - 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Results publication: PubMed 25311370Breakey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Stinson, PhD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teens Taking Charge: Managing Hemophilia Online- Online self-management intervention in people with Hemophilia A, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-specific knowledge gained (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01477437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.