A Self-Management Intervention for Youth With Sickle Cell Disease and Their Families: Phase I

NCT03069430 | Completed DMC

• 1 other identifier: Pro00057046
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia, Sickle Cell

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  through study completion, approximately one hour

Interventions

SELFY (Self Management for Youth with SCD) BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Shannon Phillips, PhD, RN

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RN, Assistant Professor

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: March 3, 2017
• Study Start: August 1, 2016
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)