Studies
| Study First Submitted Date | 2022-05-09 |
| Study First Posted Date | 2022-05-20 |
| Last Update Posted Date | 2023-06-07 |
| Start Month Year | September 2023 |
| Primary Completion Month Year | June 2024 |
| Verification Month Year | May 2023 |
| Verification Date | 2023-05-31 |
| Last Update Posted Date | 2023-06-07 |
Conditions
| Sequence: | 52426466 |
| Name | Sickle Cell Disease |
| Downcase Name | sickle cell disease |
Id Information
| Sequence: | 40340090 |
| Id Source | org_study_id |
| Id Value | 348507 |
Design Groups
| Sequence: | 55876751 |
| Group Type | Experimental |
| Title | Shared Decision Making Intervention |
Interventions
| Sequence: | 52735914 |
| Intervention Type | Behavioral |
| Name | Shared Decision Making Intervention |
| Description | We are currently developing a shared decision making intervention for AYAs with SCD to provide decision supports for disease-modifying therapies. As the intervention is currently in development, additional details will be provided once development and usability testing phases have been completed. |
Design Outcomes
| Sequence: | 178338570 | Sequence: | 178338571 | Sequence: | 178338572 | Sequence: | 178338573 | Sequence: | 178338574 | Sequence: | 178338575 | Sequence: | 178338576 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary |
| Measure | Acceptability of Intervention Measure (AIM) | Measure | Patient/Caregiver Satisfaction Questionnaire | Measure | Feasibility of Intervention Measure (FIM) | Measure | Participant Recruitment Rate | Measure | Shared Decision Making Questionnaire (SDM-Q-9) | Measure | Disease-Modifying Therapy Knowledge Questionnaire | Measure | Initiation of disease-modifying therapy |
| Time Frame | Within 2 weeks post-intervention | Time Frame | Within 2 weeks post-intervention | Time Frame | Within 2 weeks post-intervention | Time Frame | Time of enrollment through study completion, approximately 12 months | Time Frame | Within 2 weeks post-intervention | Time Frame | Within 2 weeks post-intervention | Time Frame | Within 6 months post-intervention |
| Description | Questionnaire assessing healthcare provider perspectives on acceptability of the intervention. Total score ranges from 4-20, with higher scores indicating greater acceptability. | Description | Survey assessing patient/caregiver satisfaction with the intervention. Survey will be developed by the research team, and additional details will be included here once items and scoring are finalized. | Description | Questionnaire assessing healthcare provider perspectives on the feasibility of the intervention. Total score ranges from 4-20, with higher scores indicating greater feasibility. | Description | Rate of participant enrollment and retention in the study | Description | Questionnaire assessing patient- and caregiver-reported engagement in decision making. Total score ranges from 0 to 100, with higher scores indicating greater engagement in decision making. | Description | Questionnaire assessing patient and caregiver knowledge of disease modifying-therapies for sickle cell disease. Survey will be developed by the research team, and additional details will be included here once items and scoring are finalized. | Description | Proportion of patients who agree to initiate a disease-modifying therapy following use of the shared decision making intervention |
Browse Conditions
| Sequence: | 194457785 | Sequence: | 194457786 | Sequence: | 194457787 | Sequence: | 194457788 | Sequence: | 194457789 | Sequence: | 194457790 | Sequence: | 194457791 |
| Mesh Term | Anemia, Sickle Cell | Mesh Term | Anemia, Hemolytic, Congenital | Mesh Term | Anemia, Hemolytic | Mesh Term | Anemia | Mesh Term | Hematologic Diseases | Mesh Term | Hemoglobinopathies | Mesh Term | Genetic Diseases, Inborn |
| Downcase Mesh Term | anemia, sickle cell | Downcase Mesh Term | anemia, hemolytic, congenital | Downcase Mesh Term | anemia, hemolytic | Downcase Mesh Term | anemia | Downcase Mesh Term | hematologic diseases | Downcase Mesh Term | hemoglobinopathies | Downcase Mesh Term | genetic diseases, inborn |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48555837 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Nemours Children's Clinic |
Design Group Interventions
| Sequence: | 68498061 |
| Design Group Id | 55876751 |
| Intervention Id | 52735914 |
Eligibilities
| Sequence: | 30911898 |
| Gender | All |
| Minimum Age | 15 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: Patients diagnosed with SCD ages 15-25 years receiving treatment at Nemours or ChristianaCare and their caregivers will be included. Patients must be deemed candidates for initiation of one or more disease-modifying therapies by their SCD healthcare provider. Nemours and ChristianaCare SCD healthcare providers will also be included. English language fluency is a requirement for all participants. Exclusion Criteria: Patients/ caregivers who previously participated in usability testing of the intervention will be excluded. Patients will also be excluded if their medical status or cognitive functioning preclude completion of interviews or if no legal guardian is available to provide consent (for patients < 18 years). Providers still completing training will be excluded. |
| Adult | True |
| Child | True |
| Older Adult | True |
Calculated Values
| Sequence: | 254173979 |
| Registered In Calendar Year | 2022 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 15 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 6 |
| Number Of Secondary Outcomes To Measure | 1 |
Designs
| Sequence: | 30657598 |
| Allocation | N/A |
| Intervention Model | Single Group Assignment |
| Observational Model | |
| Primary Purpose | Supportive Care |
| Time Perspective | |
| Masking | None (Open Label) |
Responsible Parties
| Sequence: | 29024267 |
| Responsible Party Type | Sponsor |