Self-Management for Youth and Families Living With SCD - SMYLS
- Conditions
- Sickle Cell Disease
- Interventions
- Behavioral: Voice Crisis Alert V2
- Registration Number
- NCT03585543
- Lead Sponsor
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- Parent/caregiver or child with cognitive disability or delay that precludes ability to participate
- Lack of wi-fi access
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single group intervention arm Voice Crisis Alert V2 -
- Primary Outcome Measures
Name Time Method Rates of Recruitment 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.
Participant Adherence to Intervention baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months number of participants who sent messages to nurse practitioner
Acceptability of Intervention 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.
- Secondary Outcome Measures
Name Time Method Difference in Mean Scores for Anxiety From Baseline to End-of-intervention 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
Difference in Mean Pain Score Rating From Baseline to End-of-intervention 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
Difference in Mean Caregiver Self-efficacy Score From Baseline to End-of-intervention 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
Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-intervention 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
Difference in Mean Scores for Fatigue From Baseline to End-of-intervention 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
Differences in Mean Scores for Pain Intensity From Baseline to End-of-intervention 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
Home Medication Administration 12 weeks Adherence to home medications, measured by number of medications marked as taken in the app database.
Differences in Mean Scores for Quality of Life From Baseline to End-of-intervention 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
Differences in Mean Scores for Disease-related Quality of Life From Baseline to End-of-intervention 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
Clinic Appointment Attendance 12 weeks Number of missed clinic appointments at baseline compared to 12 weeks
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States