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

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ClinicalTrials.gov Identifier: NCT03585543
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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)

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: Voice Crisis Alert V2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Self-Management for Youth and Families Living With Sickle Cell Disease - SMYLS
Actual Study Start Date : March 16, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Voice Crisis Alert V2
    Intervention consists of a mHealth app delivered via smartphone


Primary Outcome Measures :
  1. Rates of recruitment [ Time Frame: 3 months ]
    Number of eligible participants approached, consented, and enrolled each week

  2. Participant adherence to intervention [ Time Frame: 12 weeks ]
    Number of days with symptoms recorded

  3. Acceptability of intervention [ Time Frame: 12 weeks ]
    Number of problems reported per week, types of problems reported

  4. Participant adherence to intervention [ Time Frame: 12 weeks ]
    number of times educational component of intervention accessed

  5. Participant adherence to intervention [ Time Frame: 12 weeks ]
    length of time in minutes educational component accessed

  6. Participant adherence to intervention [ Time Frame: 12 weeks ]
    number of messages to nurse


Secondary Outcome Measures :
  1. Number of participants with improved pain ratings [ Time Frame: baseline, 6 weeks, 12 weeks, 3 months post-intervention ]
    Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference Pediatric Short Form 8a: Change in score at 6 weeks minus baseline, 12 weeks minus baseline, and 12 weeks minus 6 weeks. Raw scores range from 0 - 32, with 0 being the lowest pain rating and 32 the highest pain rating. Any decrease in rating = improved

  2. Number of participants (caregivers) with improved self-efficacy rating [ Time Frame: baseline, 6 weeks, 12 weeks, 3 months post-intervention ]

    Patient Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for managing chronic conditions:

    Subscales: Self-efficacy for managing emotions 4a, Self-efficacy for managing symptoms 4a, Self-efficacy for managing daily activities 4a, Self-efficacy for managing social interactions 4a, Self-efficacy for managing medications and treatments 4a: Raw Scores for each subscale range from 4 - 20, with 4 being the lowest level of self-efficacy and 20 the highest level of self-efficacy. Change in score at 6 weeks minus baseline, 12 weeks minus baseline, and 12 weeks minus 6 weeks. Any increase in rating = improved


  3. Number of participants with improved quality of life rating [ Time Frame: baseline, 6 weeks, 12 weeks, 3 months post-intervention ]
    Pediatric Quality of Life Inventory (Peds QL) with SCD module: Scores are transformed on a scale from 0 - 100, with 0 indicating the highest possible problems with quality of life and 100 indicating the lowest possible problems with quality of life. Change in score at 6 weeks minus baseline, 12 weeks minus baseline, and 12 weeks minus 6 weeks. Any increase in rating = improved

  4. Number of participants with improved fatigue rating [ Time Frame: baseline, 6 weeks, 12 weeks, 3 months post-intervention ]
    Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Pediatric Short Form 10a: Raw Scores range from 0 - 40 with 0 being the least amount of fatigue and 40 the most fatigue. Change in score at 6 weeks minus baseline, 12 weeks minus baseline, and 12 weeks minus 6 weeks. Any decrease in rating = improved

  5. Number of participants with improved anxiety rating [ Time Frame: baseline, 6 weeks, 12 weeks, 3 months post-intervention ]
    Patient Reported Outcomes Measurement System (PROMIS) Pediatric Short Form Anxiety 8a: Raw Scores range from 0 - 32, with 0 being the lowest anxiety rating and 32 the highest anxiety rating. Change in score at 6 weeks minus baseline, 12 weeks minus baseline, and 12 weeks minus 6 weeks. Any decrease in rating = improved

  6. Number of participants with improved depressive symptoms rating [ Time Frame: baseline, 6 weeks, 12 weeks, 3 months post-intervention ]
    Patient Reported Outcomes Measurement System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Change in score at 6 weeks minus baseline, 12 weeks minus baseline, and 12 weeks minus 6 weeks. Any decrease in rating = improved

  7. Symptom monitoring and tracking [ Time Frame: 12 weeks ]
    number of days with recorded symptoms

  8. Clinic appointment attendance [ Time Frame: 12 weeks ]
    number of scheduled clinic appointments attended

  9. Home medication administration [ Time Frame: 12 weeks ]
    number of days daily medication administered, number of days PRN medications administered

  10. Symptom monitoring and tracking [ Time Frame: 12 weeks ]
    number of days with recorded treatments for symptoms

  11. Symptom monitoring and tracking [ Time Frame: 12 weeks ]
    types of recorded treatments for symptoms



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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585543


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03585543     History of Changes
Other Study ID Numbers: Pro00062837
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn