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

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

Study Overview

• Status: Completed
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Behavioral: Voice Crisis Alert V2

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single group intervention arm	Behavioral: Voice Crisis Alert V2; Intervention consists of a mHealth app delivered via smartphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of Recruitment	Number of weeks required to recruit 30 participants.	Assessed each week over a period of 6 months, cumulative data up to 6 months is reported.
Participant Adherence to Intervention	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.	baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months
Acceptability of Intervention	Number of participants reporting problems with the intervention (mHealth app) per week.	Assessed each week over a period of 6 months, cumulative data up to 6 months is reported.
Participant Adherence to Intervention	number of participants who accessed the educational component of intervention, assessed using back end app use database	baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months
Participant Adherence to Intervention	Number of participants who accessed the symptom monitoring component of the intervention, assessed using the app back end database	baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months
Participant Adherence to Intervention	number of participants who sent messages to nurse practitioner	baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Mean Pain Score Rating From Baseline to End-of-intervention	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	baseline, 12 weeks
Difference in Mean Caregiver Self-efficacy Score From Baseline to End-of-intervention	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	baseline, 12 weeks
Differences in Mean Scores for Quality of Life From Baseline to End-of-intervention	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	baseline, 12 weeks
Difference in Mean Scores for Fatigue From Baseline to End-of-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. Difference in mean scores at 12 weeks minus baseline. Any decrease in rating = improved	baseline, 12 weeks
Difference in Mean Scores for Anxiety From Baseline to End-of-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 12 weeks minus baseline. Any decrease difference in mean scores = improved	baseline, 12 weeks
Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-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 12 weeks minus baseline. Any decrease in differences in mean scores = improved	baseline,12 weeks
Differences in Mean Scores for Pain Intensity From Baseline to End-of-intervention	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	baseline, 12 weeks
Differences in Mean Scores for Disease-related Quality of Life From Baseline to End-of-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 12 weeks minus baseline. Any increase in difference between mean scores = improved	baseline, 12 weeks
Clinic Appointment Attendance	Number of missed clinic appointments at baseline compared to 12 weeks	12 weeks
Home Medication Administration	Adherence to home medications, measured by number of medications marked as taken in the app database.	12 weeks

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: Pro00062837

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No