Anemia, Sickle CellNCT03069430
A Self-Management Intervention for Youth With Sickle Cell Disease and Their Families: Phase I
An observational study of Anemia, Sickle Cell, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study is being conducted to test an intervention for children and adolescents ages 8-17 years with sickle cell disease and their families. In the first phase of this study, key informant interviews are being conducted with health care providers and children ages 8-17 with sickle cell disease and their primary… 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?
- SELFY (Self Management for Youth with SCD)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 31 Mar 2017
- 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: Up to 15 parent/caregiver child dyads (30 individuals) and up to 15 healthcare providers will be recruited and enrolled in the study. No sex/gender or racial/ethnic group will be excluded. However, it is anticipated that the majority or all of the parent/caregiver child dyads will be African American since SCD is predominantly seen in this population. Pregnant women will not be excluded. Children ages 8-17 years will be recruited to participate in this study. Participation will include child-parent/caregiver dyads to solicit feedback from both groups and obtain a more comprehensive, family-level perspective on the intervention.
Who may be able to join
- Children ages 8-17 years and their primary caregiver
- Child with SCD as indicated by self/parent report or report from MUSC Pediatric Sickle Cell clinic staff
- Child has been seen at the MUSC Pediatric Sickle Cell clinic for at least 6 months
- MUSC Pediatric Sickle Cell clinic staff report preventive recommendations are followed by child/caregiver
- Health care providers:
- Age 18 years or older
- Healthcare professional with at least 6 months' experience caring for children with SCD
Who cannot join
- Non-English speaking
- Inability or unwillingness to participate in a one-on-one interview
- Inability or unwillingness of parent/caregiver or health care provider to give informed consent and of child to give assent
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Self Management for Families and Youth: Phase I
This study is being conducted to test an intervention for children and adolescents ages 8-17 years with sickle cell disease and their families. In the first phase of this study, key informant interviews are being conducted with health care providers and children ages 8-17 with sickle cell disease and their primary caregivers. Participants are asked to review the intervention and provide feedback that will inform revision to the intervention.
Read the detailed description
Key informant, semi-structured interviews are conducted using an interview guide to obtain expert provider (healthcare providers of children with SCD) and end-user (children and parents/caregivers) feedback on the intervention. Interview questions are designed to solicit information on advantages and disadvantages, perceived usefulness, and recommendations for improvement on the intervention. The interviews will last approximately 1 hour and are audio recorded. Recordings are transcribed for analysis. Data are analyzed using a deductive-inductive approach with the intervention as a framework for initial categories. Findings will inform revisions to the intervention. Feasibility testing of the revised intervention will be conducted in the next phase of the study.
- Conditions
- Anemia, Sickle Cell
- Being tested
- SELFY (Self Management for Youth with SCD)
- 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.
SELFY (Self Management for Youth with SCD)Behavioural
The intervention will be delivered via a mobile device (tablet) and consists of three components. 1. Education, will consist of continuous access to electronic educational resources on the SCD process, treatment, home management strategies, symptom prevention and management strategies. To address potential literacy barriers, an application that reads PDF files aloud will be downloaded onto devices. 2. symptom monitoring and tracking, will consist of an application for tracking and monitoring pain in SCD that also permits upload of symptom logs and text alerts to a health care provider. 3. caregiver-provider communication, consists of SMS messaging with a nurse who will: respond to alerts, monitor pain symptoms delivered via the mHealth application, and respond to text messages.
What is being measured
The primary outcome is the main question the study is designed to answer.
End-user perceptions of intervention using semi-structured, key informant interviews
Themes or categories developed from analysis of qualitative data on child/caregiver perceptions of the intervention.
Measured: through study completion, approximately one hour
Expert provider perceptions of intervention using semi-structured, key informant interviews
Themes or categories developed from analysis of qualitative data on health care provider perceptions of the intervention.
Measured: through study completion, approximately one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Aug 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Sickle CellStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shannon Phillips, Medical University of South Carolina
- Investigators
- Shannon Phillips, PhD, RN, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069430
- Sponsor's protocol ID
- Pro00057046
- Status last verified
- May 2018
- First submitted
- 23 Feb 2017
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be available to study mentors and the biostatistician.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Management for Families and Youth: Phase I
- ClinicalTrials.gov ID
- NCT03069430
- Acronym / sponsor ID
- Pro00057046
- Conditions
- Anemia, Sickle Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 3 Mar 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.
This study is being conducted to test an intervention for children and adolescents ages 8-17 years with sickle cell disease and their families. In the first phase of this study, key informant interviews are being conducted with health care providers and children ages 8-17 with sickle cell disease and their primary caregivers. Participants are asked to review the intervention and provide feedback that will inform revision to the intervention.
Detailed description
Key informant, semi-structured interviews are conducted using an interview guide to obtain expert provider (healthcare providers of children with SCD) and end-user (children and parents/caregivers) feedback on the intervention. Interview questions are designed to solicit information on advantages and disadvantages, perceived usefulness, and recommendations for improvement on the intervention. The interviews will last approximately 1 hour and are audio recorded. Recordings are transcribed for analysis. Data are analyzed using a deductive-inductive approach with the intervention as a framework for initial categories. Findings will inform revisions to the intervention. Feasibility testing of the revised intervention will be conducted in the next phase of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 15 parent/caregiver child dyads (30 individuals) and up to 15 healthcare providers will be recruited and enrolled in the study. No sex/gender or racial/ethnic group will be excluded. However, it is anticipated that the majority or all of the parent/caregiver child dyads will be African American since SCD is predominantly seen in this population. Pregnant women will not be excluded. Children ages 8-17 years will be recruited to participate in this study. Participation will include child-parent/caregiver dyads to solicit feedback from both groups and obtain a more comprehensive, family-level perspective on the intervention.
Key inclusion criteria (7 listed)
- Children ages 8-17 years and their primary caregiver
- Child with SCD as indicated by self/parent report or report from MUSC Pediatric Sickle Cell clinic staff
- Child has been seen at the MUSC Pediatric Sickle Cell clinic for at least 6 months
- MUSC Pediatric Sickle Cell clinic staff report preventive recommendations are followed by child/caregiver
- Age 18 years or older
Key exclusion criteria (3 listed)
- Non-English speaking
- Inability or unwillingness to participate in a one-on-one interview
- Inability or unwillingness of parent/caregiver or health care provider to give informed consent and of child to give assent
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 |
|---|---|---|
| SELFY (Self Management for Youth with SCD)The intervention will be delivered via a mobile device (tablet) and consists of three components. 1. Education, will consist of continuous access to electronic educational resources on the SCD process, treatment, home management strategies, symptom prevention and management strategies. To address potential literacy barriers, an application that reads PDF files aloud will be downloaded onto devices. 2. symptom monitoring and tracking, will consist of an application for tracking and monitoring pain in SCD that also permits upload of symptom logs and text alerts to a health care provider. 3. caregiver-provider communication, consists of SMS messaging with a nurse who will: respond to alerts, monitor pain symptoms delivered via the mHealth application, and respond to text messages. | Behavioural | – |
Primary outcome
End-user perceptions of intervention using semi-structured, key informant interviews
Time frame: through study completion, approximately one hour
Themes or categories developed from analysis of qualitative data on child/caregiver perceptions of the intervention.
Expert provider perceptions of intervention using semi-structured, key informant interviews
Time frame: through study completion, approximately one hour
Themes or categories developed from analysis of qualitative data on health care provider perceptions of the intervention.
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 11 May 2018.
- Individual participant dataSharing planned: No. IPD will only be available to study mentors and the biostatistician.
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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.
Shannon Phillips, PhD, RN principal investigator
Medical University of South Carolina
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 Medical University of South Carolina 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 7 inclusion and 3 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 11 May 2018. 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?
End-user perceptions of intervention using semi-structured, key informant interviews (time frame: through study completion, approximately one hour). 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?
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 11 May 2018.