Sickle Cell DiseaseNCT03224429
Sickle Cell Disease (SCD) Decision Aid
A study testing Qualitative Interviews Decisional Needs Assessment and Sickle Cell Decision Aid in people with Sickle Cell Disease, run by Emory University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Qualitative Interviews Decisional Needs Assessment and Sickle Cell Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2014to 31 Mar 2015
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -Individual diagnosed with sickle cell disease (SCD) or parent/legal guardian/caregiver of individual (of any age) diagnosed with SCD
Who cannot join
- There are no exclusions to study participation.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Qualitative Interviews Decisional Needs Assessment, Sickle Cell Decision Aid
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative Interviews Decisional Needs AssessmentOther
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.
Sickle Cell Decision AidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Decisional Needs Assessment | Other | Caregivers and patients with sickle cell disease will participate in a semi-structured open ended interview regarding treatment decision making. Receives: Other: Qualitative Interviews Decisional Needs Assessment |
| Beta Testing | Other | Caregivers and patients with sickle cell disease will review the web-based Sickle Cell Decision Aid. Receives: Other: Sickle Cell Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient/Caregiver Knowledge of Treatment Risks
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.
Measured: Up to 90 Minutes
Patient/Caregiver Knowledge of Treatment Benefits
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.
Measured: Up to 90 Minutes
Patient/Caregiver Treatment Expectations
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.
Measured: Up to 90 Minutes
Barriers to Understanding Treatment Options
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.
Measured: Up to 90 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start15 May 2014
- Primary completion31 Mar 2015
- Study completion31 Mar 2015
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 Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Lakshmanan Krishnamurti, Emory University
- Investigators
- Lakshmanan Krishnamurti, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224429
- Sponsor's protocol ID
- IRB00076096
- Status last verified
- Jun 2018
- First submitted
- 18 Jul 2017
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Krishnamurti L, Ross D, Sinha C, Leong T, Bakshi N, Mittal N, Veludhandi D, Pham AP, Taneja A, Gupta K, Nwanze J, Matthews AM, Joshi S, Vazquez Olivieri V, Arjunan S, Okonkwo I, Lukombo I, Lane P, Bakshi N, Loewenstein G. Comparative Effectiveness of a Web-Based Patient Decision Aid for Therapeutic Options for Sickle Cell Disease: Randomized Controlled Trial. J Med Internet Res. 2019 Dec 4;21(12):e14462. doi: 10.2196/14462.
PubMed 31799940
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of a Decision Aid for Therapeutic Options in Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT03224429
- Acronym / sponsor ID
- IRB00076096
- Conditions
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 15 May 2014 (actual)
- Primary completion
- 31 Mar 2015 (actual)
- Study completion
- 31 Mar 2015 (actual)
- First posted
- 21 Jul 2017 (actual)
- 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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decisional Needs Assessment | Other | Other: Qualitative Interviews Decisional Needs AssessmentCaregivers and patients with sickle cell disease will participate in a semi-structured open ended interview regarding treatment decision making. |
| Beta Testing | Other | Other: Sickle Cell Decision AidCaregivers and patients with sickle cell disease will review the web-based Sickle Cell Decision Aid. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -Individual diagnosed with sickle cell disease (SCD) or parent/legal guardian/caregiver of individual (of any age) diagnosed with SCD
Key exclusion criteria (1 listed)
- There are no exclusions to study participation.
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 |
|---|---|---|
| Qualitative Interviews Decisional Needs AssessmentSubjects 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 | Decisional Needs Assessment |
| Sickle Cell Decision AidParticipants 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. | Other | Beta Testing |
Primary outcome
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.
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.
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.
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.
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 15 Jun 2018.
- Derived from this study: PubMed 31799940Krishnamurti L, Ross D, Sinha C, Leong T, Bakshi N, Mittal N, Veludhandi D, Pham AP, Taneja A, Gupta K, Nwanze J, Matthews AM, Joshi S, Vazquez Olivieri V, Arjunan S, Okonkwo I, Lukombo I, Lane P, Bakshi N, Loewenstein G. Comparative Effectiveness of a Web-Based Patient Decision Aid for Therapeutic Options for Sickle Cell Disease: Randomized Controlled Trial. J Med Internet Res. 2019 Dec 4;21(12):e14462. doi: 10.2196/14462.
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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.
Lakshmanan Krishnamurti, MD principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
A study testing Qualitative Interviews Decisional Needs Assessment and Sickle Cell Decision Aid in people with Sickle Cell Disease, run by Emory University.
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 1 inclusion and 1 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 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Patient/Caregiver Knowledge of Treatment Risks (time frame: Up to 90 Minutes). The study lists 4 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 NCT03224429, 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 15 Jun 2018.