Sickle Cell Disease (SCD) Decision Aid

June 14, 2018 updated by: Lakshmanan Krishnamurti, Emory University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
222

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Decisional Needs Assessment
Caregivers and patients with sickle cell disease will participate in a semi-structured open ended interview regarding treatment decision making.
Other: Qualitative Interviews Decisional Needs Assessment
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.
Other: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00076096

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Sickle Cell Disease

Clinical Trials on Qualitative Interviews Decisional Needs Assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings