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Completed

NCT Number: NCT03585543

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

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)

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Voice Crisis Alert V2

Behavioral

Intervention consists of a mHealth app delivered via smartphone

Primary outcomes

  1. Rates of Recruitment

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

    Number of weeks required to recruit 30 participants.

  2. Participant Adherence to Intervention

    Time frame: baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months

    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.

  3. Acceptability of Intervention

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

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

  4. Participant Adherence to Intervention

    Time frame: baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months

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

  5. Participant Adherence to Intervention

    Time frame: baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months

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

  6. Participant Adherence to Intervention

    Time frame: baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months

    number of participants who sent messages to nurse practitioner

Secondary outcomes

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

    Time frame: baseline, 12 weeks

    Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference Pediatric Short Form 8a: Change in score at 12 weeks minus baseline. Raw scores range from 0 - 32, with 0 being the lowest pain rating and 32 the highest pain rating. Any decrease in mean difference between scores = improved

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

    Time frame: baseline, 12 weeks

    Self-efficacy for Managing Chronic Disease 6-item scale. Scores for each item range from 1 - 10 with 1 indicating lower confidence/self-efficacy and 10 indicating higher confidence/self-efficacy. Scores for each item are averaged for the mean total score. Change in score at 12 weeks minus baseline. Any increase in difference in mean scores = improved

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

    Time frame: baseline, 12 weeks

    Pediatric Quality of Life Inventory (Peds QL): 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 12 weeks minus baseline. Any increase in difference between mean scores = improved

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

    Time frame: baseline, 12 weeks

    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. Difference in mean scores at 12 weeks minus baseline. Any decrease in rating = improved

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

    Time frame: baseline, 12 weeks

    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 12 weeks minus baseline. Any decrease difference in mean scores = improved

  6. Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-intervention

    Time frame: baseline,12 weeks

    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 12 weeks minus baseline. Any decrease in differences in mean scores = improved

  7. Differences in Mean Scores for Pain Intensity From Baseline to End-of-intervention

    Time frame: baseline, 12 weeks

    Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity Pediatric 3a. Raw scores range from 3 - 15, with 3 being the lowest pain intensity rating and 15 being the highest pain intensity rating. Change in score at 12 weeks minus baseline. Any decrease in mean difference between scores = improved

  8. Differences in Mean Scores for Disease-related Quality of Life From Baseline to End-of-intervention

    Time frame: baseline, 12 weeks

    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 12 weeks minus baseline. Any increase in difference between mean scores = improved

  9. Clinic Appointment Attendance

    Time frame: 12 weeks

    Number of missed clinic appointments at baseline compared to 12 weeks

  10. Home Medication Administration

    Time frame: 12 weeks

    Adherence to home medications, measured by number of medications marked as taken in the app database.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Self-Management for Youth and Families Living With Sickle Cell Disease - SMYLS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 13, 2018
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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