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

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ClinicalTrials.gov Identifier: NCT04289311
Recruitment Status : Active, not recruiting
First Posted : February 28, 2020
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Shannon Phillips, Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE February 7, 2020
First Posted Date  ICMJE February 28, 2020
Last Update Posted Date January 28, 2021
Actual Study Start Date  ICMJE July 13, 2020
Estimated Primary Completion Date May 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2020)
  • Rate of recruitment [ Time Frame: 6 months ]
    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)
  • Participant adherence to the intervention [ Time Frame: 6 months ]
    Rate of participant use in number of times each component of the intervention is accessed over the study period
  • Acceptability of intervention to participants [ Time Frame: 6 months ]
    Number of participants who report they are satisfied or very satisfied with the intervention during semi-structured, post-intervention interview, and number of problems with intervention reported to study staff over the study period
  • Consistency of intervention delivery [ Time Frame: 6 months ]
    Number of participants to whom instructions on the intervention were provided as recorded in study logs, number of participant who have questions or require assistance with using the intervention as recorded in study logs
  • Projection of future adoption [ Time Frame: 6 months ]
    Number of participants who report they are likely or very likely to continue using the intervention during post-intervention, semi-structured interviews, and the number of participants who use the intervention from the end-of-intervention (12 weeks) to 3 months post-intervention (6 months) as recorded in application back-end database
  • Self-management behaviors [ Time Frame: 6 months ]
    Assessment of participant self-management behaviors, including symptom monitoring and tracking, adherence to clinic appointments, and medication adherence. Symptom monitoring and tracking measured through the application back-end database as number of times each participant accesses the symptom monitoring and symptom tracking components of the application. Adherence to appointments as assessed by study-specific questions asked during study visits at 6 weeks, 12 weeks, and 6 months. Questions ask whether any appointments were scheduled and missed or attended since the last study visit. Medication adherence measured as number of scheduled medication doses marked as "taken" in the application back-end database out of the total number of possible doses
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2020)
  • Change in child and caregiver symptoms (pain, fatigue, depressive symptoms, anxiety, self-efficacy, and sleep disturbance) from baseline to end-of-intervention [ Time Frame: 6 months ]
    Assessed using the following scales: PROMIS Pediatric Pain Interference SF, Pediatric and Adult PROMIS Fatigue SF, Pediatric and Adolescent PROMIS Depressive Symptoms SF, Pediatric and Adolescent Anxiety SF, Sickle Cell Disease Self-Efficacy Scale, Adult PROMIS Sleep Disturbances SF, Adolescent Sleep Wake Scale. For all PROMIS measures, higher scores indicate more of the concept being studied. For the Sickle Cell Self-efficacy Scale, a higher score indicates greater self-efficacy. For the Adolescent Sleep Wake Scale, higher scores indicate better sleep quality.
  • Change in health-related quality of life from baseline to end-of-intervention [ Time Frame: 6 months ]
    Assessed using the Pediatric Quality of Life instrument, in which higher scores indicate greater quality of life, and the Sickle Cell Disease Module of the Pediatric Quality of Life instrument, in which higher scores indicate greater quality of life.
  • Transition readiness and change in transition readiness from baseline to end-of-intervention [ Time Frame: 6 months ]
    Assessed using the STARx, in which higher scores indicate greater readiness for transition and the Parent and Youth Sickle Cell Responsibility Scales. Items on the Sickle Cell Responsibility Scales indicate whether parents or children are taking responsibility for health care treatments and are analyzed in conjunction to determine the level of child treatment responsibility, and agreement between the youth and parent for responsibilities
  • Healthcare utilization [ Time Frame: 6 months ]
    Assessed using study-specific items. Items ask whether the participant has had any appointments since the last study visit and whether the appointment was attended or missed. Items also ask whether the participant has had any emergency department visits since the last study visit.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SMYLS: A Self-management Program for Youth Living With Sickle Cell Disease
Official Title  ICMJE SMYLS: A Self-management Program for Youth Living With Sickle Cell Disease
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.
Detailed Description The purpose of the proposed study is to test the feasibility of SMYLS, an mHealth intervention designed to facilitate self-management behaviors in children and adolescents with sickle cell disease (SCD). Specifically, the investigators propose to test the feasibility of the intervention for improving transition from parent-managed to adolescent self-managed care. In addition, the investigators will evaluate the communication that takes place via the intervention between adolescents, their parents/caregivers, and healthcare providers. The investigators will work with the MUSC Pediatric Sickle Cell Clinic to identify and recruit 5 healthcare providers of children with SCD and 30 dyads of adolescents ages 11 - 17 SCD and their parent/caregiver (n = 60).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE Behavioral: Voice Crisis Alert V2
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).
Study Arms  ICMJE Experimental: Intervention arm
Single group study; all participants are in the intervention arm and receive the intervention
Intervention: Behavioral: Voice Crisis Alert V2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 26, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 19, 2021
Estimated Primary Completion Date May 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04289311
Other Study ID Numbers  ICMJE Pro00084400
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shannon Phillips, Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of South Carolina
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP