Clinical trial NCT03069430: A Self-Management Intervention for Youth With Sickle Cell Disease and Their Families: Phase I
Official title: Self Management for Families and Youth: Phase I
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia, Sickle Cell
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: End-user perceptions of intervention using semi-structured, key informant interviews
timeFrame: through study completion, approximately one hour
measure: Expert provider perceptions of intervention using semi-structured, key informant interviews
timeFrame: through study completion, approximately one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Shannon Phillips, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: