- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04289311
SMYLS: A Self-management Program for Youth Living With Sickle Cell Disease
December 17, 2021 updated by: Shannon Phillips, Medical University of South Carolina
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention arm
Single group study; all participants are in the intervention arm and receive the intervention
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of recruitment
Time Frame: 6 months
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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)
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6 months
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Participant adherence to the intervention
Time Frame: 6 months
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Rate of participant use in number of times each component of the intervention is accessed over the study period
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6 months
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Acceptability of intervention to participants
Time Frame: 6 months
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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
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6 months
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Consistency of intervention delivery
Time Frame: 6 months
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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
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6 months
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Projection of future adoption
Time Frame: 6 months
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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
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6 months
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Self-management behaviors
Time Frame: 6 months
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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
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in child and caregiver symptoms (pain, fatigue, depressive symptoms, anxiety, self-efficacy, and sleep disturbance) from baseline to end-of-intervention
Time Frame: 6 months
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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.
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6 months
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Change in health-related quality of life from baseline to end-of-intervention
Time Frame: 6 months
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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.
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6 months
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Transition readiness and change in transition readiness from baseline to end-of-intervention
Time Frame: 6 months
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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
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6 months
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Healthcare utilization
Time Frame: 6 months
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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.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 13, 2020
Primary Completion (Actual)
May 11, 2021
Study Completion (Actual)
December 17, 2021
Study Registration Dates
First Submitted
February 7, 2020
First Submitted That Met QC Criteria
February 26, 2020
First Posted (Actual)
February 28, 2020
Study Record Updates
Last Update Posted (Actual)
December 20, 2021
Last Update Submitted That Met QC Criteria
December 17, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00084400
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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