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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289311
• Other study ID #: Pro00084400
• Status: Completed
• Phase: N/A
• Start date: July 13, 2020
• Est. completion date: December 17, 2021

Study information

• Verified date: December 2021
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 17, 2021
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Behavioral:
• Voice Crisis Alert V2
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).

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	Rate of recruitment	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)	6 months
Primary	Participant adherence to the intervention	Rate of participant use in number of times each component of the intervention is accessed over the study period	6 months
Primary	Acceptability of intervention to participants	Number of participants who report they are satisfied or very satisfied with the intervention during semi-structured, post-intervention interview, and number of problems with intervention reported to study staff over the study period	6 months
Primary	Consistency of intervention delivery	Number of participants to whom instructions on the intervention were provided as recorded in study logs, number of participant who have questions or require assistance with using the intervention as recorded in study logs	6 months
Primary	Projection of future adoption	Number of participants who report they are likely or very likely to continue using the intervention during post-intervention, semi-structured interviews, and the number of participants who use the intervention from the end-of-intervention (12 weeks) to 3 months post-intervention (6 months) as recorded in application back-end database	6 months
Primary	Self-management behaviors	Assessment of participant self-management behaviors, including symptom monitoring and tracking, adherence to clinic appointments, and medication adherence. Symptom monitoring and tracking measured through the application back-end database as number of times each participant accesses the symptom monitoring and symptom tracking components of the application. Adherence to appointments as assessed by study-specific questions asked during study visits at 6 weeks, 12 weeks, and 6 months. Questions ask whether any appointments were scheduled and missed or attended since the last study visit. Medication adherence measured as number of scheduled medication doses marked as "taken" in the application back-end database out of the total number of possible doses	6 months
Secondary	Change in child and caregiver symptoms (pain, fatigue, depressive symptoms, anxiety, self-efficacy, and sleep disturbance) from baseline to end-of-intervention	Assessed using the following scales: PROMIS Pediatric Pain Interference SF, Pediatric and Adult PROMIS Fatigue SF, Pediatric and Adolescent PROMIS Depressive Symptoms SF, Pediatric and Adolescent Anxiety SF, Sickle Cell Disease Self-Efficacy Scale, Adult PROMIS Sleep Disturbances SF, Adolescent Sleep Wake Scale. For all PROMIS measures, higher scores indicate more of the concept being studied. For the Sickle Cell Self-efficacy Scale, a higher score indicates greater self-efficacy. For the Adolescent Sleep Wake Scale, higher scores indicate better sleep quality.	6 months
Secondary	Change in health-related quality of life from baseline to end-of-intervention	Assessed using the Pediatric Quality of Life instrument, in which higher scores indicate greater quality of life, and the Sickle Cell Disease Module of the Pediatric Quality of Life instrument, in which higher scores indicate greater quality of life.	6 months
Secondary	Transition readiness and change in transition readiness from baseline to end-of-intervention	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	6 months
Secondary	Healthcare utilization	Assessed using study-specific items. Items ask whether the participant has had any appointments since the last study visit and whether the appointment was attended or missed. Items also ask whether the participant has had any emergency department visits since the last study visit.	6 months