SMYLS Multi-site Trial
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Study participants randomized to receive the 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.
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| Active Comparator: Control Study participants randomized to receive enhanced usual care (control). |
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- Self-management behaviors [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.
Secondary Outcome Measures
- Engagement in intervention/control (categorical) [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.
- Engagement in intervention/control (continuous) [Ongoing]
Number of times the application is accessed (intervention = full application; control = educational component only).
- Health-related quality of life [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.
- Number of attended SCD clinic visits [baseline and 1, 3, 6, 9, and 12 months]
Number of attended SCD clinic visits documented in the medical record
- Number of ED visits [baseline and 1, 3, 6, 9, and 12 months]
Number of ED visits documented in the medical record
- Number of hospitalizations [baseline and 1, 3, 6, 9, and 12 months]
Number of hospitalizations documented in the medical record
- Pain interference [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.
- Transition readiness [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.
Other Outcome Measures
- Patient activation [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.
- Neurocognitive/executive functioning [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.
- Social resources and conditions [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).
- Depressive symptoms [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.
- Anxiety [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.
- Fatigue [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.
- Family functioning [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.
- Health literacy [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.
- Perceived stigma [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.
- Sleep disturbance [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.
- Perceived discrimination [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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documentation in the electronic health record of any type of SCD
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owns mobile device compatible with the intervention
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access to the internet
Exclusion Criteria:
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Plans to relocate outside of study site area in the next 12 months
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Plans to transition to adult care in 12 months or less
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Parent/caregiver or provider report of neurocognitive impairment that precludes ability to use intervention and participate in study
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non-English speaking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
Sponsors and Collaborators
- Medical University of South Carolina
- National Institute of Nursing Research (NINR)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00127137
- 1R01NR020606-01