SMYLS Multi-site Trial

Sickle Cell Disease Clinical Trial

Official title:

Self-Management for Youth Living With Sickle Cell Disease: SMYLS Multi-site Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035939
• Other study ID #: Pro00127137
• Secondary ID: 1R01NR020606-01
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2024
• Est. completion date: January 31, 2028

Study information

• Verified date: April 2024
• Source: Medical University of South Carolina
• Contact: Shannon Phillips, PhD, RN
• Phone: 843-792-9379
• Email: phillipss[@]musc.edu
• 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 app is helpful for teens and young adults with sickle cell disease (SCD) in learning how to care for and manage their symptoms.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 272
• Est. completion date: January 31, 2028
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Behavioral:
• Voice Crisis Alert V2
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.
• Electronic educational materials
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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient activation	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
Other	Neurocognitive/executive functioning	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
Other	Social resources and conditions	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
Other	Depressive symptoms	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.	baseline, 9 months
Other	Anxiety	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
Other	Fatigue	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
Other	Family functioning	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
Other	Health literacy	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.	baseline, 9 months
Other	Perceived stigma	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
Other	Sleep disturbance	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
Other	Perceived discrimination	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
Primary	Self-management behaviors	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	Engagement in intervention/control (categorical)	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
Secondary	Engagement in intervention/control (continuous)	Number of times the application is accessed (intervention = full application; control = educational component only).	Ongoing
Secondary	Health-related quality of life	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
Secondary	Number of attended SCD clinic visits	Number of attended SCD clinic visits documented in the medical record	baseline and 1, 3, 6, 9, and 12 months
Secondary	Number of ED visits	Number of ED visits documented in the medical record	baseline and 1, 3, 6, 9, and 12 months
Secondary	Number of hospitalizations	Number of hospitalizations documented in the medical record	baseline and 1, 3, 6, 9, and 12 months
Secondary	Pain interference	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
Secondary	Transition readiness	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