Sickle Cell TraitSCTawareNCT03984500
A Program to Increase Sickle Cell Trait Knowledge Among Parent of Young Children Identified in Newborn Screening
A study testing Education in people with Sickle Cell Trait, run by Susan Creary at 1 site in United States.
Trial summary
This is a study for parents of young children with Sickle Cell Trait (SCT) identified by newborn screening who are referred and present for in person SCT education at the Institution. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Trait
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2019to 1 Jun 2022
- Phase
- Interventional
- 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
Who may be able to join
- Adult biological parents of children <3 years old with Hemoglobin S-trait identified by NBS who present for SCT education at NCH.
- English proficiency will be required
Who cannot join
- Parents who self-report that they do not have functional verbal English (report that they are not proficient) or if they request an interpreter for the education session.
- Parents who have previously attended an education session about an abnormal hemoglobinopathy trait
- Parents who self-report that they have a child with SCD
- Parents who self-report that they have SCD.
- Parents who report that they or their partner is currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: A Comprehensive Program to Increase Sickle Cell Trait Knowledge and Awareness Among Parents of Young Children Identified in Newborn Screening
This is a study for parents of young children with Sickle Cell Trait (SCT) identified by newborn screening who are referred and present for in person SCT education at the Institution.
The study will determine the feasibility of implementing a SCT education program (SCTaware) that is appropriate for all parents, including those with low base knowledge and low health literacy and then test if results in high and sustained SCT knowledge.
Read the detailed description
This is a single center, observational study to develop an education program for parents of young children diagnosed with Sickle Cell Trait. This will be accomplish by evaluating the current Ohio education in-person program, and assessing, through a set of questionnaires, how much participants are understanding about this diagnosis.
During phase I of the study, participants will be video-taped, and a set of questionnaires will be answer before and after education is given. This data will then be analyzed by the SCT Team in order to develop the Program.
During phase II of the study, population with the same criteria as phase I will be enrolled, however they will receive the revised "SCTaware" education. Pre and post education questionnaires will also be answered. In addition, participants during this phase will receive follow-up calls at 1 and 6 months to complete additional surveys.
In addition, the investigators will be using the Decisional Conflict Scale (DCS) to explore if parents experience decisional conflict about whether or not to obtain SCT testing and if SCTaware reduces this conflict
- Conditions
- Sickle Cell Trait
- Being tested
- Education
- Keywords
- Sickle Cell Trait, Education
- Medical subject headings
- Sickle Cell Trait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
SCTaware education (Phase II) will be compared to Ohio's current in-person SCT education (Phase I).
| Study group | Role | What they receive |
|---|---|---|
| Education | Other | During phase 1 of this study parents who attend in person education sessions will be recruited to have their standard sessions video-taped, timed, and reviewed by the SCTaware Team. Subjects will complete before and after education questionnaires that will then be reviewed to see how much participants learned about SCT, how education was not clear and/or appropriate (too much medical jargon). The SCTaware education will then be created based on review of these videos and participants' survey responses.
For phase 2 of the study, the same recruitment strategy will be utilized. Participants will receive SCTaware and complete before and after questionnaires for evaluation. Participants in this phase will also complete follow-up questionnaires at 1 and 6 months. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of implementing of a Sickle Cell Trait education Program: The time required to train a sickle cell trait educator and to deliver the revised sickle cell trait education will be measured
The time required to train a sickle cell trait educator and to deliver the revised sickle cell trait education will be measured. The program will be feasible if the time to train the educator and deliver the education can be completed within the context of the current sickle cell trait education program in Ohio.
Measured: 2 years
Parental Sickle Cell Trait Knowledge
Parental Sickle Cell Trait Knowledge will be measured before the education, immediately after the education, and 6 months after the education is provided using the 8-question Sickle Cell Trait Knowledge Assessment Measure. Parents that score 75% correct on this measure or higher will be considered to have high knowledge. The proportion of those parents who have high knowledge prior to the education will be compared to the percentage of parents that have high knowledge 6-months after receiving the education.
Measured: 2 years
Secondary outcomes (4)
Percentage of Parents who receive on-site Sickle Cell Trait testing
On-site sickle cell trait testing will be available for all parents and will be ordered for all parents who accept this testing. The percentage of enrolled parents that accept and obtain on-site testing will be measured by the number of parents who accept this testing divided by the total number of parents who receive the education.
Measured: 2 years
Decisional Conflict Scale
Parents will complete the 16 item validated decisional conflict scale survey before and after education to measure if parents' confidence or difficulty in making the decision whether or not to be tested for sickle cell trait improved with sickle cell trait education. These results are reported as a total score, with 5 sub-scores (uncertainty, informed, values clarity, support, and effective decision sub-scores). The total score and the sub-scores range from 0-100, with a score of 0 indicating no conflict/uncertainty and a score of 100 indicating extreme conflict/uncertainty.
Measured: 2 years
Parental Anxiety
Parents will complete the state trait anxiety short from survey before and after receiving sickle cell trait education to measure if the education reduces parents' state anxiety about having a child with sickle cell trait.
Measured: 2 years
Sickle Cell Trait Testing Cost
Parents will complete the sickle cell trait needs assessment survey that includes an item that asks participants if the cost of sickle cell testing impacted their decision whether or not to be tested for sickle cell trait.
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 posted13 Jun 2019
- Study start18 Jun 2019
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell TraitStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susan Creary
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Susan Creary, Nationwide Children's Hospital
- Investigators
- Susan Creary, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984500
- Sponsor's protocol ID
- STUDY00000122
- Other IDs
- 1R03HL146877-01
- Acronym
- SCTaware
- Status last verified
- Dec 2022
- First submitted
- 31 May 2019
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abrams MA, Zajo KN, Beeman CM, O'Brien SH, Chan PK, Shen Y, McCorkle B, Johnson L, Chisolm D, Barnard-Kirk T, Mahan JD, Christian-Rancy M, Creary SE. A Health Literate Approach to Address Health Disparities: a Virtual Program for Parents of Children with Sickle Cell Trait. J Commun Healthc. 2022;15(2):112-120. doi: 10.1080/17538068.2022.2026056. Epub 2022 Jan 19.
PubMed 36275941
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Program to Increase Sickle Cell Trait Knowledge and Awareness Among Parents of Young Children Identified in Newborn Screening
- ClinicalTrials.gov ID
- NCT03984500
- Acronym / sponsor ID
- SCTaware / STUDY00000122
- Conditions
- Sickle Cell Trait
- Keywords
- Sickle Cell Trait, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Susan CrearyUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 13 Jun 2019 (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.
This is a study for parents of young children with Sickle Cell Trait (SCT) identified by newborn screening who are referred and present for in person SCT education at the Institution.
The study will determine the feasibility of implementing a SCT education program (SCTaware) that is appropriate for all parents, including those with low base knowledge and low health literacy and then test if results in high and sustained SCT knowledge.
Detailed description
This is a single center, observational study to develop an education program for parents of young children diagnosed with Sickle Cell Trait. This will be accomplish by evaluating the current Ohio education in-person program, and assessing, through a set of questionnaires, how much participants are understanding about this diagnosis.
During phase I of the study, participants will be video-taped, and a set of questionnaires will be answer before and after education is given. This data will then be analyzed by the SCT Team in order to develop the Program.
During phase II of the study, population with the same criteria as phase I will be enrolled, however they will receive the revised "SCTaware" education. Pre and post education questionnaires will also be answered. In addition, participants during this phase will receive follow-up calls at 1 and 6 months to complete additional surveys.
In addition, the investigators will be using the Decisional Conflict Scale (DCS) to explore if parents experience decisional conflict about whether or not to obtain SCT testing and if SCTaware reduces this conflict
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education | Other | Other: EducationDuring phase 1 of this study parents who attend in person education sessions will be recruited to have their standard sessions video-taped, timed, and reviewed by the SCTaware Team. Subjects will complete before and after education questionnaires that will then be reviewed to see how much participants learned about SCT, how education was not clear and/or appropriate (too much medical jargon). The SCTaware education will then be created based on review of these videos and participants' survey responses. For phase 2 of the study, the same recruitment strategy will be utilized. Participants will receive SCTaware and complete before and after questionnaires for evaluation. Participants in this phase will also complete follow-up questionnaires at 1 and 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult biological parents of children <3 years old with Hemoglobin S-trait identified by NBS who present for SCT education at NCH.
- English proficiency will be required
Key exclusion criteria (5 listed)
- Parents who self-report that they do not have functional verbal English (report that they are not proficient) or if they request an interpreter for the education session.
- Parents who have previously attended an education session about an abnormal hemoglobinopathy trait
- Parents who self-report that they have a child with SCD
- Parents who self-report that they have SCD.
- Parents who report that they or their partner is currently pregnant
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 |
|---|---|---|
| EducationSCTaware education (Phase II) will be compared to Ohio's current in-person SCT education (Phase I). | Other | Education |
Primary outcome
Feasibility of implementing of a Sickle Cell Trait education Program: The time required to train a sickle cell trait educator and to deliver the revised sickle cell trait education will be measured
Time frame: 2 years
The time required to train a sickle cell trait educator and to deliver the revised sickle cell trait education will be measured. The program will be feasible if the time to train the educator and deliver the education can be completed within the context of the current sickle cell trait education program in Ohio.
Parental Sickle Cell Trait Knowledge
Time frame: 2 years
Parental Sickle Cell Trait Knowledge will be measured before the education, immediately after the education, and 6 months after the education is provided using the 8-question Sickle Cell Trait Knowledge Assessment Measure. Parents that score 75% correct on this measure or higher will be considered to have high knowledge. The proportion of those parents who have high knowledge prior to the education will be compared to the percentage of parents that have high knowledge 6-months after receiving the education.
4 secondary outcomes
Percentage of Parents who receive on-site Sickle Cell Trait testing
Time frame: 2 years
Decisional Conflict Scale
Time frame: 2 years
Parental Anxiety
Time frame: 2 years
Sickle Cell Trait Testing Cost
Time frame: 2 years
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 21 Dec 2022.
- Derived from this study: PubMed 36275941Abrams MA, Zajo KN, Beeman CM, O'Brien SH, Chan PK, Shen Y, McCorkle B, Johnson L, Chisolm D, Barnard-Kirk T, Mahan JD, Christian-Rancy M, Creary SE. A Health Literate Approach to Address Health Disparities: a Virtual Program for Parents of Children with Sickle Cell Trait. J Commun Healthc. 2022;15(2):112-120. doi: 10.1080/17538068.2022.2026056. Epub 2022 Jan 19.
- Individual participant dataSharing planned: Undecided
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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.
Susan Creary, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Sickle Cell Trait, run by Susan Creary 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 2 inclusion and 5 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 21 Dec 2022. 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?
Feasibility of implementing of a Sickle Cell Trait education Program: The time required to train a sickle cell trait educator and to deliver the revised sickle cell trait education will be measured (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT03984500, which also lists 1 linked publication.
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 21 Dec 2022.