Sickle Cell Disease (SCD) Decision Aid

NCT03224429 | Completed

• 1 other identifier: IRB00076096
• Study Type: interventional
• Target: 222
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Up to 90 Minutes

Study Arms (2)

Decisional Needs Assessment

OTHER

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

Beta Testing

OTHER

Caregivers and patients with sickle cell disease will review the web-based Sickle Cell Decision Aid.

Other: Sickle Cell Decision Aid

Interventions

Qualitative Interviews Decisional Needs Assessment OTHER

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.

Decisional Needs Assessment

Sickle Cell Decision Aid OTHER

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.

Beta Testing

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual diagnosed with sickle cell disease (SCD) or parent/legal guardian/caregiver of individual (of any age) diagnosed with SCD

Sponsors & Collaborators

• Emory University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Related Publications (1)

• 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.

  PMID: 31799940 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Lakshmanan Krishnamurti, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 21, 2017
• Study Start: May 15, 2014
• Primary Completion: March 31, 2015
• Study Completion: March 31, 2015
• Last Updated: June 15, 2018

Record last verified: 2018-06