We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Specifying Interventions From the Sickle Cell Disease Implementation Consortium (SCDIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03380351
Recruitment Status : Recruiting
First Posted : December 21, 2017
Last Update Posted : January 31, 2023
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The goal of this study is to specify the interventions, implementation strategies and control conditions from the Sickle Cell Disease Implementation Consortium (SCDIC) using a mixed-methods approach to study site materials and conduct semi-structured qualitative interviews with site representatives (N=3 per site).

Condition or disease Intervention/treatment
Anemia, Sickle Cell Behavioral: SCDIC interventions Behavioral: SCDIC control groups

Detailed Description:
The long-term goal of this line of research is to identify the most effective components of SCD interventions while also identifying effective implementation strategies informed by a systematic and rigorous work done by the members of the SCDIC consortium to improve the quality of life of people with SCD, a life-threatening hematological disorder. This study aims to collect detailed information about the planned interventions, the implementation strategies and the control conditions from each site.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Implementation of Cognitive Screening and Educational Support to Improve Outcomes of Adolescents and Young Adults With Sickle Cell Disease: From Clinic to the Community and Back
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
SCDIC interventions
Careful detail the intervention components and the implementation strategies (i.e., the mechanisms by which the interventions are being delivered in usual care) being developed by the consortium.
 Behavioral: SCDIC interventions
The research team will characterize the intervention components and their implementation strategies.
SCDIC control groups
Careful detail the control conditions of each of the SCDIC sites for each of the interventions being developed.
 Behavioral: SCDIC control groups
The research team will characterize the control settings, including patients, providers and organization.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. SCDIC Framework of Interventions [ Time Frame: 2 years ]
    Detailed descriptions of the interventions being developed by the SCDIC including a) entity, or entities, targeted by the intervention; (b) functional domains targeted by the interventions; and (c) delivery system characteristics


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study is focused on gathering data about the interventions planned and delivered from three different stakeholders of each site.
Criteria

Inclusion Criteria:

  • three representatives of each of the SDIC sites: the Principal Investigator, and two people nominated by the PI.

Exclusion Criteria:

  • none
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380351


Contacts
Layout table for location contacts
Contact: Ana Baumann, PhD 314 935 3585 abaumann@gwbmail.wustl.edu
Contact: Allison King, MD, MPH, PhD 3144544291 king_a@wustl.edu

Locations
Layout table for location information
United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ana Baumann, PhD    314-935-3585    abaumann@gwbmail.wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Ana Baumann, PhD Washington University School of Medicine
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03380351    
Other Study ID Numbers: 3U01HL133994-02S1 ( U.S. NIH Grant/Contract )
3U01HL133994-02S1 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Along the study, we will share the information gathered with participants to check for accuracy. The framework of the interventions will be shared with the participants during the SCDIC Steering Committee calls.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: data will be available in two years for the remaining of the 2 years of the consortium.
Access Criteria: Assess will be given to all participants via the Consortium's webpage
URL: https://scdic.rti.org/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn