Self-Management for Youth and Families Living With SCD - SMYLS

NCT03585543 | Completed Results DMC

• 1 other identifier: Pro00062837
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this proposal is to integrate family-centered self-management strategies with mobile health (mHealth) technology to improve reach, self-management behaviors, and child and caregiver physical and psychosocial symptoms and quality of life. Specifically, the investigators propose to conduct feasibility testing of SMYLS, which has been adapted based on user feedback in the first phase of this study. First the investigators will work with the Medical University of South Carolina (MUSC) Pediatric Sickle Cell Clinic to identify and recruit families with children with sickle cell disease (SCD) in the community, statewide. Next, the investigators will test the feasibility of the intervention with 30 dyads of children ages 8 - 17 with sickle cell disease and their parent or primary caregiver, (N=60)

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (6)

• Rates of Recruitment

  Number of weeks required to recruit 30 participants.

  Assessed each week over a period of 6 months, cumulative data up to 6 months is reported.

• Participant Adherence to Intervention

  Number of participants who used the intervention (mHealth application) from baseline to mid-intervention, from mid-intervention to end-of-intervention, and from end-of-intervention to follow-up, assessed by number of participants who logged into and used the app, stored in the app's back end database.

  baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months

• Acceptability of Intervention

  Number of participants reporting problems with the intervention (mHealth app) per week.

  Assessed each week over a period of 6 months, cumulative data up to 6 months is reported.

• Participant Adherence to Intervention

  number of participants who accessed the educational component of intervention, assessed using back end app use database

  baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months

• Participant Adherence to Intervention

  Number of participants who accessed the symptom monitoring component of the intervention, assessed using the app back end database

  baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months

• Participant Adherence to Intervention

  number of participants who sent messages to nurse practitioner

  baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months

Secondary Outcomes (10)

• Difference in Mean Pain Score Rating From Baseline to End-of-intervention

  baseline, 12 weeks

• Difference in Mean Caregiver Self-efficacy Score From Baseline to End-of-intervention

  baseline, 12 weeks

• Differences in Mean Scores for Quality of Life From Baseline to End-of-intervention

  baseline, 12 weeks

• Difference in Mean Scores for Fatigue From Baseline to End-of-intervention

  baseline, 12 weeks

• Difference in Mean Scores for Anxiety From Baseline to End-of-intervention

  baseline, 12 weeks

Study Arms (1)

Single group intervention arm

EXPERIMENTAL

Behavioral: Voice Crisis Alert V2

Interventions

Voice Crisis Alert V2 BEHAVIORAL

Intervention consists of a mHealth app delivered via smartphone

Single group intervention arm

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children ages 8 - 17 years and parent or primary caregiver 18 years or older
• child with sickle cell disease, as reported by clinician at MUSC Pediatric Sickle Cell Clinic

You may not qualify if:

• Parent/caregiver or child with cognitive disability or delay that precludes ability to participate
• Lack of wi-fi access

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

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

Limitations and Caveats

Limitations of this feasibility study included technical difficulties with the app, leading to an inability to accurately assess medication adherence data and measurement issues with the clinic appointment attendance. We were unable to assess these additional outcome measures with accuracy.

Results Point of Contact

• Title: Shannon Phillips, PhD, RN, Associate Professor
• Organization: Medical University of South Carolina College of Nursing

phillipss@musc.edu

843-792-9379

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: July 13, 2018
• Study Start: March 16, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: November 19, 2020
• Results First Posted: April 16, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)