SMYLS: A Self-management Program for Youth Living With Sickle Cell Disease

NCT04289311 | Completed Results DMC

• 1 other identifier: Pro00084400
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out whether a web-based intervention using a mobile device is helpful for teens learning to care for and manage symptoms of sickle cell disease. The intervention lasts 12 weeks with a 3-month follow up period, and uses a smartphone or a tablet.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (7)

• Rate of Recruitment: Dyads

  Number of participant dyads recruited and enrolled per week. (Benchmark is 2 dyads recruited and enrolled per week to reach sample size of 30 dyads)

  6 months

• Participant Adherence to the Intervention

  Number of participants (adolescent/caregiver dyads and young adults) using the app from baseline to 6 weeks

  baseline to 6 weeks

• Consistency of Intervention Delivery

  Number of participants (adolescent/caregiver dyads and young adults) to whom instructions on the intervention were provided as recorded in study logs

  24 weeks

• Projection of Future Adoption

  Number of participants (adolescent/caregiver dyads and individual young adults) who report they are likely or very likely to continue using the intervention during post-intervention, semi-structured interviews

  12 weeks

• Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 6 Weeks to 12 Weeks

  Number of participants (adolescent/caregiver dyads and young adults) who used the intervention from week 6 to week 12

  6 weeks to 12 weeks

• Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 12 Weeks to 24 Weeks

  Number of participants (adolescent/caregiver dyads and young adults) who used the intervention from week 12 to week 24

  12 weeks to 24 weeks

• Rate of Recruitment: Young Adults

  Number of young adult participants recruited and enrolled per week. (Benchmark is 2 young adults recruited per week to reach a sample size of 15).

  6 months

Secondary Outcomes (9)

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

  baseline, 12 weeks

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

  baseline, 12 weeks

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

  baseline, 12 weeks

• Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-Intervention

  baseline, 12 weeks

• Differences in Mean Scores for Pain Intensity From Baseline to End-of-interention

  baseline, 12 weeks

Study Arms (1)

Intervention arm

EXPERIMENTAL

Single group study; all participants are in the intervention arm and receive the intervention

Behavioral: Voice Crisis Alert V2

Interventions

Voice Crisis Alert V2 BEHAVIORAL

An mHealth intervention (app) with multiple components for self-management behavior development. Components include: electronic educational information, symptom monitoring and tracking, communication with a provider, health history entry and storage (including medication adherence).

Intervention arm

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of SCD as reported by provider
• self-reported history of pain at least once per month
• caregiver/parent willingness to participate
• owns a smartphone

You may not qualify if:

• not under the care of a provider participant
• cognitive disability or delay that precludes ability to participate, defined as classified severe neurocognitive deficits as documented by neuropsychological evaluation in the medical record
• 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 measurement issues with the clinic appointment attendance. We were unable to assess this outcome measure with accuracy.

Results Point of Contact

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

phillipss@musc.edu

843-792-9379

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 28, 2020
• Study Start: July 13, 2020
• Primary Completion: May 11, 2021
• Study Completion: December 17, 2021
• Last Updated: August 16, 2024
• Results First Posted: August 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)