- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06035939
SMYLS Multi-site Trial
April 25, 2024 updated by: Shannon Phillips, Medical University of South Carolina
Self-Management for Youth Living With Sickle Cell Disease: SMYLS Multi-site Trial
The purpose of this study is to find out whether a web-based intervention using a mobile app is helpful for teens and young adults with sickle cell disease (SCD) in learning how to care for and manage their symptoms.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to test the effectiveness of and identify barriers and facilitators to the implementation of SMYLS, an mHealth intervention designed to facilitate self-management behaviors in adolescents and young adults (AYA) with sickle cell disease (SCD).
Specifically, the investigators propose to determine the effect of the intervention on the primary outcome of self-management behaviors and the secondary outcomes of quality of life, transition readiness, healthcare utilization, and pain interference.
In addition, the investigators will explore how patient activation moderates development of self-management behaviors and systemic, structural, and social variables that moderate relationships between patient activation, the primary outcome, and secondary outcomes.
Study Type
Interventional
Enrollment (Estimated)
272
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 Contact
- Name: Shannon Phillips, PhD, RN
- Phone Number: 843-792-9379
- Email: phillipss@musc.edu
Study Contact Backup
- Name: Margie Prentice, MBA
- Phone Number: 843-792-4771
- Email: prenticm@musc.edu
Study Locations
-
-
South Carolina
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Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina
-
Contact:
- Shannon Phillips, PhD, RN
- Phone Number: 843-792-9379
- Email: phillipss@musc.edu
-
Contact:
- Mohan Madisetti
- Phone Number: 843-792-2059
- Email: madisett@musc.edu
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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
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- documentation in the electronic health record of any type of SCD
- owns mobile device compatible with the intervention
- access to the internet
Exclusion Criteria:
- Plans to relocate outside of study site area in the next 12 months
- Plans to transition to adult care in 12 months or less
- Parent/caregiver or provider report of neurocognitive impairment that precludes ability to use intervention and participate in study
- non-English speaking
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Study participants randomized to receive the intervention.
|
The mHealth self-management intervention consists of the following components: 1) condition-specific electronic educational materials; 2) pain/symptom monitoring and tracking; 3) health history information documentation; 4) medication tracking; 5) secure messaging with a provider; 6) functioning monitoring and tracking; and 7) transmission of health information (graphs with recorded pain and functioning histories) to a provider.
|
Active Comparator: Control
Study participants randomized to receive enhanced usual care (control).
|
The control arm will receive enhanced usual care, which will consist of usual educational materials distributed at the clinic plus a version of the intervention (Voice Crisis Alert V2) that only includes the electronic educational materials.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-management behaviors
Time Frame: baseline and 1, 3, 6, 9, 12 months
|
Adolescent and young adult self-report using the Transition Readiness Assessment Questionnaire 5th version (TRAQ-5; 20 items).
The instrument consists of 5 scales.
Individual item scores range from 1 - 5. Scale scores are determined by calculating the average of the item scores within each scale.
Higher scores indicate greater transition readiness and self-management behaviors.
|
baseline and 1, 3, 6, 9, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engagement in intervention/control (categorical)
Time Frame: baseline and 1, 3, 6, 9, 12 months
|
Categorized into none, low, moderate and high.
For intervention arm, categories are based on scope (number of components), duration (number of weeks), and frequency (number of times per week).
For control arm, categories are based on duration and frequency as for intervention group parameters.
|
baseline and 1, 3, 6, 9, 12 months
|
Engagement in intervention/control (continuous)
Time Frame: Ongoing
|
Number of times the application is accessed (intervention = full application; control = educational component only).
|
Ongoing
|
Health-related quality of life
Time Frame: baseline and 1, 3, 6, 9, and 12 months
|
Adolescent and young adult self report using the Pediatric Quality of Life Inventory (PedsQL) with Sickle Cell Disease Module (43 items).
Items are scaled from 0 (Never) to 4 (Almost always).
Scores are reverse scored and linearly transformed to a 0 - 100 scale.
Higher scores indicate better health-related quality of life.
|
baseline and 1, 3, 6, 9, and 12 months
|
Number of attended SCD clinic visits
Time Frame: baseline and 1, 3, 6, 9, and 12 months
|
Number of attended SCD clinic visits documented in the medical record
|
baseline and 1, 3, 6, 9, and 12 months
|
Number of ED visits
Time Frame: baseline and 1, 3, 6, 9, and 12 months
|
Number of ED visits documented in the medical record
|
baseline and 1, 3, 6, 9, and 12 months
|
Number of hospitalizations
Time Frame: baseline and 1, 3, 6, 9, and 12 months
|
Number of hospitalizations documented in the medical record
|
baseline and 1, 3, 6, 9, and 12 months
|
Pain interference
Time Frame: baseline and 1, 3, 6, 9, and 12, months
|
Adolescent and young adult self report using the Patient Reported Outcomes Measurement Inventory System (PROMIS) Pain Interference v2 Pediatric Short Form (8 items).
Raw scores range from 0 - 32 with higher scores indicating greater pain interference.
|
baseline and 1, 3, 6, 9, and 12, months
|
Transition readiness
Time Frame: baseline and 1, 3, 6, 9, and 12 months
|
Adolescent and young adult self report using the Transition Intervention Program - Readiness for Transition (TIP-RFT; 22 items).
Scores for each item range from 0 - 4, with a total possible summed score ranging from 0 - 88. Lower scores indicate higher transition readiness.
|
baseline and 1, 3, 6, 9, and 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient activation
Time Frame: baseline and 1, 3, 6, 9, and 12 months
|
Moderator variable; adolescent and young adult self-report using the Patient Activation Measure (PAM-13).
Raw scores are transformed to a scale of 0 - 100 with 100 being the highest activation level.
|
baseline and 1, 3, 6, 9, and 12 months
|
Neurocognitive/executive functioning
Time Frame: baseline, 9 months
|
Moderator variable; adolescent's parent/caregiver report using the Behavior Rating Inventory of Executive Function, 2nd ed.
(BRIEF-2; 12 items).
Raw scale scores are transformed to T scores.
T scores from 60-64 are mildly elevated problems with executive functioning, T scores from 65-69 are considered potentially clinically elevated problems with executive functioning, and T scores at or above 70 are considered clinically elevated problems with executive functioning.
|
baseline, 9 months
|
Social resources and conditions
Time Frame: baseline, 9 months
|
Moderator variable; based on residential address using the Child Opportunity Index (COI).
9-month measurement will assess change in address and change in COI.
All United States neighborhoods are scored and ranked from lowest to highest opportunity.
Five levels of opportunity are used (very low, low, moderate, high, very high) and scores range from 1 (lowest opportunity) to 100 (highest opportunity).
|
baseline, 9 months
|
Depressive symptoms
Time Frame: baseline, 9 months
|
Moderator variable; adolescent and young adult self report using the Patient Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms v2 Pediatric Short Form (8 items).
Raw scores range from 0 - 32 with higher scores indicating greater depressive symptoms.
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baseline, 9 months
|
Anxiety
Time Frame: baseline, 9 months
|
Moderator variable; adolescent and young adult self report using the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety v2 Pediatric Short Form (8 items).
Raw scores range from 0 - 32 with higher scores indicating greater anxiety.
|
baseline, 9 months
|
Fatigue
Time Frame: baseline, 9 months
|
Moderator variable; adolescent and young adult self report using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue v2 Pediatric Short Form (10 items).
Raw scores range from 0 - 40 with higher scores indicating greater fatigue.
|
baseline, 9 months
|
Family functioning
Time Frame: baseline, 9 months
|
Moderator variable; parent/caregiver of adolescent report using the McMaster Family Functioning Assessment Device (12 items).
Items response options range from 1 (strongly agree) to 4 (strongly disagree).
All odd items are reverse scored.
After reverse scoring, all items are summed.
Lower total scores indicate higher levels of family functioning.
|
baseline, 9 months
|
Health literacy
Time Frame: baseline, 9 months
|
Moderator variable; adolescent and young adult self report using the Newest Vital Sign (NVS; 6 items).
Items are scored from 0 - 6 and summed.
Total scores of 0 - 1 indicate a high likelihood of limited literacy, 2 - 3 a possibility of limited literacy, and 4 - 6 adequate literacy.
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baseline, 9 months
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Perceived stigma
Time Frame: baseline, 9 months
|
Moderator variable; adolescent and young adult self report using the Child Stigma Scale (8 items).
Each item is rated from from 0 (Never) to 4 (Very often).
Higher scores indicate greater perceived stigma.
|
baseline, 9 months
|
Sleep disturbance
Time Frame: baseline, 9 months
|
Moderator variable; adolescent and young adult self report using the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance v1 Pediatric Short Form (4 items).
Raw scores range from 0 - 16 with higher scores indicating greater sleep disturbance.
|
baseline, 9 months
|
Perceived discrimination
Time Frame: baseline, 9 months
|
Moderator variable; adolescent and young adult self report using the Discrimination subscale of the Interpersonal Processes of Care instrument (2 items).
Response options range from 1 (Never) to 5 (Always).
Total score is calculated as the mean of responses, with higher scores indicating higher frequency of discrimination.
|
baseline, 9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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)
April 4, 2024
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
January 31, 2028
Study Registration Dates
First Submitted
August 29, 2023
First Submitted That Met QC Criteria
September 6, 2023
First Posted (Actual)
September 13, 2023
Study Record Updates
Last Update Posted (Estimated)
April 26, 2024
Last Update Submitted That Met QC Criteria
April 25, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00127137
- 1R01NR020606-01 (U.S. NIH Grant/Contract)
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
product manufactured in and exported from the U.S.
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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