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Completed

NCT Number: NCT04289311

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

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.

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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

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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).

Primary outcomes

  1. Rate of Recruitment: Dyads

    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)

  2. Participant Adherence to the Intervention

    Time frame: baseline to 6 weeks

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

  3. Consistency of Intervention Delivery

    Time frame: 24 weeks

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

  4. Projection of Future Adoption

    Time frame: 12 weeks

    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

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

    Time frame: 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. Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 12 Weeks to 24 Weeks

    Time frame: 12 weeks to 24 weeks

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

  7. Rate of Recruitment: Young Adults

    Time frame: 6 months

    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).

Secondary outcomes

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

    Time frame: baseline, 12 weeks

    Adolescents: 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 Young adults: Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form 8a: Change in score at 12 weeks minus baseline. Raw scores range from 8 - 40 with 8 being the lowest pain rating and 40 the highest pain rating. Any decrease in mean difference between scores = improved

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

    Time frame: baseline, 12 weeks

    Adolescents and Young Adults: 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. Each item is scored individually and is worth 1 to 5 points. There are 3 subdomains; subdomain scores are summed for the total score, which ranges from 0 - 90 points. Higher scores = improvement

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

    Time frame: baseline, 12 weeks

    Adolescents: 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 Young adults: Patient Reported Outcomes Measurement System (PROMIS) Short Form Anxiety 8a: Raw Scores range from 8 - 40 with 8 being the lowest anxiety rating and 40 the highest anxiety rating. Change in score at 12 weeks minus baseline. Any decrease difference in mean scores = improved Caregivers: Patient Reported Outcomes Measurement System (PROMIS) Short Form Anxiety 4a: Raw scores range from 4 - 20 with 4 being the lowest anxiety rating and 20 the highest anxiety rating. Change in score at 12 weeks minus baseline. Any decrease difference in mean scores = improved

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

    Time frame: baseline, 12 weeks

    Adolescents: 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 Young Adults: Patient Reported Outcomes Measurement System (PROMIS) short form depression 8a: Raw scores range from 8 - 40, with 8 being the lowest depression rating and 40 the highest depression rating. Change in score at 12 weeks minus baseline. Any decrease in differences in mean scores = improved Caregivers: Patient Reported Outcomes Measurement System (PROMIS) depression 4a: Raw scores range from 4 - 20, with 4 being the lowest depression rating and 20 the highest depression rating. Change in score at 12 weeks minus baseline. Any decrease in differences in mean scores = improved

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

    Time frame: baseline, 12 weeks

    Adolescents: 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.

    Young adults: Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity v2 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.

  6. Difference in Mean Scores for Fatigue From Baseline to End-of-Intervention

    Time frame: baseline, 12 weeks

    Adolescents: 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 Young Adults: Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a: Raw scores range from 8 - 40 with 8 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 Caregivers: Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 4a: Raw scores range from 4 - 20 with 4 being the least amount of fatigue and 20 the most fatigue. Difference in mean scores at 12 weeks minus baseline. Any decrease in rating = improved

  7. Differences in Mean Scores for Quality of Life From Baseline to End-of-Intervention

    Time frame: baseline, 12 weeks

    Adolescents: 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.

    Caregivers: Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Physical: Raw scores range from 4 - 20 with 4 being the lowest global physical health and 20 the highest global physical health. Difference in mean scores at 12 weeks minus baseline. Any increase in rating = improved

  8. Differences in Mean Scores for Condition-Specific Quality of Life From Baseline to End-of-Intervention

    Time frame: baseline, 12 weeks

    Adolescents: Pediatric Quality of Life Inventory (PedsQL) 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 in means scores = improved.

    Young Adults: Adult Sickle Cell Disease Quality of Life Information System (ASCQ-Me): Raw scores for each scale (emotional impact, social impact, sleep impact, stiffness impact, pain impact) range from 5 to 25 with 5 being the lowest health-related quality of life score for each and 25 the highest. Change in score at 12 weeks minus baseline. Any increase in difference in means scores = improved.

  9. Difference in Mean Scores for Self-Efficacy From Baseline to End-of-Intervention

    Time frame: baseline, 12 weeks

    Adolescents and Young Adults: Sickle Cell Self-Efficacy Scale: Raw scores range from 9 to 45, with 9 being the lowest self-efficacy rating and 45 the highest. Change in score at 12 weeks minus baseline. Any increase in scores = improved

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 28, 2020
Registry last updated
Aug 16, 2024

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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