SMYLS: A Self-management Program for Youth Living With Sickle Cell Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04289311|
Recruitment Status : Active, not recruiting
First Posted : February 28, 2020
Last Update Posted : January 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease||Behavioral: Voice Crisis Alert V2||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||SMYLS: A Self-management Program for Youth Living With Sickle Cell Disease|
|Actual Study Start Date :||July 13, 2020|
|Estimated Primary Completion Date :||May 19, 2021|
|Estimated Study Completion Date :||May 19, 2021|
Experimental: Intervention arm
Single group study; all participants are in the intervention arm and receive the 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).
- Rate of recruitment [ Time Frame: 6 months ]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)
- Participant adherence to the intervention [ Time Frame: 6 months ]Rate of participant use in number of times each component of the intervention is accessed over the study period
- Acceptability of intervention to participants [ Time Frame: 6 months ]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
- Consistency of intervention delivery [ Time Frame: 6 months ]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
- Projection of future adoption [ Time Frame: 6 months ]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
- Self-management behaviors [ Time Frame: 6 months ]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
- 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 ]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.
- Change in health-related quality of life from baseline to end-of-intervention [ Time Frame: 6 months ]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.
- Transition readiness and change in transition readiness from baseline to end-of-intervention [ Time Frame: 6 months ]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
- Healthcare utilization [ Time Frame: 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04289311
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|