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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585543
• Other study ID #: Pro00062837
• Status: Completed
• Phase: N/A
• Start date: March 16, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: October 2020
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

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

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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.
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Clinic Appointment Attendance	Number of missed clinic appointments at baseline compared to 12 weeks	12 weeks
Secondary	Home Medication Administration	Adherence to home medications, measured by number of medications marked as taken in the app database.	12 weeks