Anemia, Sickle CellNCT03380351
Specifying Interventions From the Sickle Cell Disease Implementation Consortium (SCDIC)
An observational study of Anemia, Sickle Cell, run by Washington University School of Medicine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia, Sickle Cell
- What is being tested?
- SCDIC interventions
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2019to 30 Mar 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study is focused on gathering data about the interventions planned and delivered from three different stakeholders of each site.
Who may be able to join
- three representatives of each of the SDIC sites: the Principal Investigator, and two people nominated by the PI.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
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
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). We focused on the Emergency Department Working Group from the SCDIC working groups.
Read the 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.
- Conditions
- Anemia, Sickle Cell
- Being tested
- SCDIC interventions
- 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.
SCDIC interventionsBehavioural
The research team will characterize the intervention components and their implementation strategies.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SCDIC interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCDIC Framework of Interventions
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start26 Aug 2019
- Primary completion1 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anemia, Sickle CellStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ana Baumann, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380351
- Sponsor's protocol ID
- 3U01HL133994-02S1
- Other IDs
- 3U01HL133994-02S1
- Status last verified
- May 2024
- First submitted
- 20 Nov 2017
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Nwosu C, Khan H, Masese R, Nocek JM, Gollan S, Varughese T, Bourne S, Clesca C, Jacobs SR, Baumann A, Klesges LM, Shah N, Hankins JS, Smeltzer MP. Recruitment Strategies in the Integration of Mobile Health Into Sickle Cell Disease Care to Increase Hydroxyurea Utilization Study (meSH): Multicenter Survey Study. JMIR Form Res. 2024 Apr 16;8:e48767. doi: 10.2196/48767.
PubMed 38625729Baumann AA. Commentary: Adapting and Operationalizing the RE-AIM Framework for Implementation Science in Environmental Health: Clean Fuel Cooking Programs in Low Resource Countries. Front Public Health. 2020 Jun 9;8:218. doi: 10.3389/fpubh.2020.00218. eCollection 2020. No abstract available.
PubMed 32582613Baumann AA, Belle SH, James A, King AA; Sickle Cell Disease Implementation Consortium. Specifying sickle cell disease interventions: a study protocol of the Sickle Cell Disease Implementation Consortium (SCDIC). BMC Health Serv Res. 2018 Jun 27;18(1):500. doi: 10.1186/s12913-018-3297-1.
PubMed 29945631
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03380351
- Acronym / sponsor ID
- 3U01HL133994-02S1
- Conditions
- Anemia, Sickle Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 21 Dec 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 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). We focused on the Emergency Department Working Group from the SCDIC working 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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCDIC interventions | – | Behavioral: SCDIC interventionsCareful 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study is focused on gathering data about the interventions planned and delivered from three different stakeholders of each site.
Key inclusion criteria (1 listed)
- three representatives of each of the SDIC sites: the Principal Investigator, and two people nominated by the PI.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| SCDIC interventionsThe research team will characterize the intervention components and their implementation strategies. | Behavioural | SCDIC interventions |
Primary outcome
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
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 8 May 2024.
- Derived from this study: PubMed 38625729Nwosu C, Khan H, Masese R, Nocek JM, Gollan S, Varughese T, Bourne S, Clesca C, Jacobs SR, Baumann A, Klesges LM, Shah N, Hankins JS, Smeltzer MP. Recruitment Strategies in the Integration of Mobile Health Into Sickle Cell Disease Care to Increase Hydroxyurea Utilization Study (meSH): Multicenter Survey Study. JMIR Form Res. 2024 Apr 16;8:e48767. doi: 10.2196/48767.
- Derived from this study: PubMed 32582613Baumann AA. Commentary: Adapting and Operationalizing the RE-AIM Framework for Implementation Science in Environmental Health: Clean Fuel Cooking Programs in Low Resource Countries. Front Public Health. 2020 Jun 9;8:218. doi: 10.3389/fpubh.2020.00218. eCollection 2020. No abstract available.
- Derived from this study: PubMed 29945631Baumann AA, Belle SH, James A, King AA; Sickle Cell Disease Implementation Consortium. Specifying sickle cell disease interventions: a study protocol of the Sickle Cell Disease Implementation Consortium (SCDIC). BMC Health Serv Res. 2018 Jun 27;18(1):500. doi: 10.1186/s12913-018-3297-1.
- Individual participant dataSharing planned: Yes. 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.
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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.
Ana Baumann, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, Sickle Cell, run by Washington University School of Medicine at 1 site in United States.
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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
SCDIC Framework of Interventions (time frame: 2 years). 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 NCT03380351, which also lists 3 linked publications.
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 8 May 2024.