- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03224429
Sickle Cell Disease (SCD) Decision Aid
Comparative Effectiveness of a Decision Aid for Therapeutic Options in Sickle Cell Disease
The purpose of this study is to gather decision making needs information from caregivers and patients with sickle cell disease (SCD) in order to develop a web-based decision aid tool. Study subjects will participate in interviews defining treatment decision making needs during which investigators will ask information about their SCD. Notes taken from these interviews will allow the research team to better understand current practice related to clinical practice and allow for better refinement of the decision aid tool.
An additional group of participants will be asked to review the web-based Sickle Cell Decision Aid. Participants will be asked to describe thoughts about the site, including but not limited to ease of navigation, content and construction.
This study will provide information for the conduct of a randomized controlled trial for the use of a web based decision aid to give patients with sickle cell disease and parent/legal guardian of children with sickle cell disease accurate information about risks and benefits of therapies and enable them to make decisions based on their individual values and preferences.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to understand patient, family and caregiver needs when making a decision about treatment for their sickle cell disease (SCD). Investigators are developing a decision aid tool that can help people understand SCD treatment options.
One group of subjects will participate in qualitative interviews defining treatment decision making needs during which investigators will ask information about their SCD. Investigators will also discuss treatment choices: hydroxyurea, chronic or monthly blood transfusions and bone marrow transplantation. Participants will be asked their thoughts about how to develop a web-based decision aid tool. Notes taken from these interviews will allow the research team to better understand current practice related to clinical practice and allow for better refinement of the decision aid tool.
An additional group of subjects will review the web-based Sickle Cell Decision Aid. Participants will be asked to navigate the site. As the participant navigates the site, the study interviewer will ask the participants to describe thoughts about the site, including but not limited to ease of navigation, content and construction. Testing may be performed in-person or via telephone. Using qualitative data collection methods, questions will be analyzed allowing for increased focus of questions based on common themes and issues identified during ongoing analysis.
This study will provide information for the conduct of a randomized controlled trial for the use of a web based decision aid to give patients with sickle cell disease and parent/legal guardian of children with sickle cell disease accurate information about risks and benefits of therapies and enable them to make decisions based on their individual values and preferences.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
-Individual diagnosed with sickle cell disease (SCD) or parent/legal guardian/caregiver of individual (of any age) diagnosed with SCD
Exclusion Criteria:
There are no exclusions to study participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Decisional Needs Assessment
Caregivers and patients with sickle cell disease will participate in a semi-structured open ended interview regarding treatment decision making.
|
Subjects will participate in an open-ended interview regarding type of sickle cell disease, complications, current treatment, and experiences with decision making and sickle cell treatment.
Participants will be asked to describe what is important when making health care decisions.
Treatment options (hydroxyurea, chronic or monthly blood transfusions, and bone marrow transplantation) will be discussed as well as how a web-based decision aid tool should be developed.
The interview will be audio recorded and will take 45 to 60 minutes to complete.
|
Other: Beta Testing
Caregivers and patients with sickle cell disease will review the web-based Sickle Cell Decision Aid.
|
Participants will be asked to navigate the Sickle Cell Decision Aid site that provides information about risks and benefits of therapies.
As the participant navigates the site, the interviewer will ask the participants to describe thoughts about the site, including but not limited to ease of navigation, content and construction.
Testing may be performed in-person or via telephone.
Interviews will be audio recorded and take up to 60 to 90 minutes to complete.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient/Caregiver Knowledge of Treatment Risks
Time Frame: Up to 90 Minutes
|
Patient and caregiver knowledge of treatment risks will be collected via an open-ended semi- structured interview and aggregated as qualitative data to identify common knowledge gaps.
|
Up to 90 Minutes
|
Patient/Caregiver Knowledge of Treatment Benefits
Time Frame: Up to 90 Minutes
|
Patient and caregiver knowledge of treatment benefits will be collected via an open-ended semi- structured interview and aggregated as qualitative data to identify common knowledge gaps.
|
Up to 90 Minutes
|
Patient/Caregiver Treatment Expectations
Time Frame: Up to 90 Minutes
|
Patient and caregiver treatment expectations will be collected via an open-ended semi- structured interview and aggregated as qualitative data to identify common knowledge gaps.
|
Up to 90 Minutes
|
Barriers to Understanding Treatment Options
Time Frame: Up to 90 Minutes
|
Patient and caregiver knowledge of treatment options will be collected via an open-ended semi- structured interview and aggregated as qualitative data to identify common knowledge gaps.
|
Up to 90 Minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00076096
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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