Sickle Cell DiseaseNCT04289311
SMYLS: A Self-management Program for Youth Living With Sickle Cell Disease
A study testing Voice Crisis Alert V2 in people with Sickle Cell Disease, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Voice Crisis Alert V2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2020to 17 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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.
Read the 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).
- Conditions
- Sickle Cell Disease
- Being tested
- Voice Crisis Alert V2
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice Crisis Alert V2Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Single group study; all participants are in the intervention arm and receive the intervention Receives: Behavioral: Voice Crisis Alert V2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Recruitment: Dyads
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)
Measured: 6 months
Participant Adherence to the Intervention
Number of participants (adolescent/caregiver dyads and young adults) using the app from baseline to 6 weeks
Measured: baseline to 6 weeks
Consistency of Intervention Delivery
Number of participants (adolescent/caregiver dyads and young adults) to whom instructions on the intervention were provided as recorded in study logs
Measured: 24 weeks
Projection of Future Adoption
Number of participants (adolescent/caregiver dyads and individual young adults) who report they are likely or very likely to continue using the intervention during post-intervention, semi-structured interviews
Measured: 12 weeks
Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 6 Weeks to 12 Weeks
Number of participants (adolescent/caregiver dyads and young adults) who used the intervention from week 6 to week 12
Measured: 6 weeks to 12 weeks
Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 12 Weeks to 24 Weeks
Number of participants (adolescent/caregiver dyads and young adults) who used the intervention from week 12 to week 24
Measured: 12 weeks to 24 weeks
Rate of Recruitment: Young Adults
Number of young adult participants recruited and enrolled per week. (Benchmark is 2 young adults recruited per week to reach a sample size of 15).
Measured: 6 months
Secondary outcomes (9)
Difference in Mean Pain Score Rating From Baseline to End-of-Intervention
Adolescents: Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference Pediatric Short Form 8a: Change in score at 12 weeks minus baseline. Raw scores range from 0 - 32 with 0 being the lowest pain rating and 32 the highest pain rating. Any decrease in mean difference between scores = improved Young adults: Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form 8a: Change in score at 12 weeks minus baseline. Raw scores range from 8 - 40 with 8 being the lowest pain rating and 40 the highest pain rating. Any decrease in mean difference between scores = improved
Measured: baseline, 12 weeks
Difference in Mean Scores for Transition Readiness From Baseline to End-of-intervention
Adolescents and Young Adults: 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. Each item is scored individually and is worth 1 to 5 points. There are 3 subdomains; subdomain scores are summed for the total score, which ranges from 0 - 90 points. Higher scores = improvement
Measured: baseline, 12 weeks
Difference in Mean Scores for Anxiety From Baseline to End-of-Intervention
Adolescents: Patient Reported Outcomes Measurement System (PROMIS) Pediatric Short Form Anxiety 8a: Raw Scores range from 0 - 32 with 0 being the lowest anxiety rating and 32 the highest anxiety rating. Change in score at 12 weeks minus baseline. Any decrease difference in mean scores = improved Young adults: Patient Reported Outcomes Measurement System (PROMIS) Short Form Anxiety 8a: Raw Scores range from 8 - 40 with 8 being the lowest anxiety rating and 40 the highest anxiety rating. Change in score at 12 weeks minus baseline. Any decrease difference in mean scores = improved Caregivers: Patient Reported Outcomes Measurement System (PROMIS) Short Form Anxiety 4a: Raw scores range from 4 - 20 with 4 being the lowest anxiety rating and 20 the highest anxiety rating. Change in score at 12 weeks minus baseline. Any decrease difference in mean scores = improved
Measured: baseline, 12 weeks
Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-Intervention
Adolescents: Patient Reported Outcomes Measurement System (PROMIS) Pediatric short form depression 8a: Raw scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Change in score at 12 weeks minus baseline. Any decrease in differences in mean scores = improved Young Adults: Patient Reported Outcomes Measurement System (PROMIS) short form depression 8a: Raw scores range from 8 - 40, with 8 being the lowest depression rating and 40 the highest depression rating. Change in score at 12 weeks minus baseline. Any decrease in differences in mean scores = improved Caregivers: Patient Reported Outcomes Measurement System (PROMIS) depression 4a: Raw scores range from 4 - 20, with 4 being the lowest depression rating and 20 the highest depression rating. Change in score at 12 weeks minus baseline. Any decrease in differences in mean scores = improved
Measured: baseline, 12 weeks
Differences in Mean Scores for Pain Intensity From Baseline to End-of-interention
Adolescents: Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity Pediatric 3a. Raw scores range from 3 - 15, with 3 being the lowest pain intensity rating and 15 being the highest pain intensity rating. Change in score at 12 weeks minus baseline. Any decrease in mean difference between scores = improved.
Young adults: Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity v2 3a. Raw scores range from 3 - 15, with 3 being the lowest pain intensity rating and 15 being the highest pain intensity rating. Change in score at 12 weeks minus baseline. Any decrease in mean difference between scores = improved.
Measured: baseline, 12 weeks
Difference in Mean Scores for Fatigue From Baseline to End-of-Intervention
Adolescents: Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Pediatric Short Form 10a: Raw scores range from 0 - 40 with 0 being the least amount of fatigue and 40 the most fatigue. Difference in mean scores at 12 weeks minus baseline. Any decrease in rating = improved Young Adults: Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a: Raw scores range from 8 - 40 with 8 being the least amount of fatigue and 40 the most fatigue. Difference in mean scores at 12 weeks minus baseline. Any decrease in rating = improved Caregivers: Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 4a: Raw scores range from 4 - 20 with 4 being the least amount of fatigue and 20 the most fatigue. Difference in mean scores at 12 weeks minus baseline. Any decrease in rating = improved
Measured: baseline, 12 weeks
Differences in Mean Scores for Quality of Life From Baseline to End-of-Intervention
Adolescents: Pediatric Quality of Life Inventory (Peds QL): Scores are transformed on a scale from 0 - 100, with 0 indicating the highest possible problems with quality of life and 100 indicating the lowest possible problems with quality of life. Change in score at 12 weeks minus baseline. Any increase in difference between mean scores = improved.
Caregivers: Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Physical: Raw scores range from 4 - 20 with 4 being the lowest global physical health and 20 the highest global physical health. Difference in mean scores at 12 weeks minus baseline. Any increase in rating = improved
Measured: baseline, 12 weeks
Differences in Mean Scores for Condition-Specific Quality of Life From Baseline to End-of-Intervention
Adolescents: Pediatric Quality of Life Inventory (PedsQL) with SCD module: Scores are transformed on a scale from 0 - 100, with 0 indicating the highest possible problems with quality of life and 100 indicating the lowest possible problems with quality of life. Change in score at 12 weeks minus baseline. Any increase in difference in means scores = improved.
Young Adults: Adult Sickle Cell Disease Quality of Life Information System (ASCQ-Me): Raw scores for each scale (emotional impact, social impact, sleep impact, stiffness impact, pain impact) range from 5 to 25 with 5 being the lowest health-related quality of life score for each and 25 the highest. Change in score at 12 weeks minus baseline. Any increase in difference in means scores = improved.
Measured: baseline, 12 weeks
Difference in Mean Scores for Self-Efficacy From Baseline to End-of-Intervention
Adolescents and Young Adults: Sickle Cell Self-Efficacy Scale: Raw scores range from 9 to 45, with 9 being the lowest self-efficacy rating and 45 the highest. Change in score at 12 weeks minus baseline. Any increase in scores = improved
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start13 Jul 2020
- Primary completion11 May 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shannon Phillips, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289311
- Sponsor's protocol ID
- Pro00084400
- Status last verified
- Mar 2024
- First submitted
- 7 Feb 2020
- Last updated
- 16 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMYLS: A Self-management Program for Youth Living With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT04289311
- Acronym / sponsor ID
- Pro00084400
- Conditions
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Posted 16 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Voice Crisis Alert V2Single group study; all participants are in the intervention arm and receive the intervention |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice Crisis Alert V2An 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). | Behavioural | Intervention arm |
Primary outcome
Rate of Recruitment: Dyads
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: baseline to 6 weeks
Number of participants (adolescent/caregiver dyads and young adults) using the app from baseline to 6 weeks
Consistency of Intervention Delivery
Time frame: 24 weeks
Number of participants (adolescent/caregiver dyads and young adults) to whom instructions on the intervention were provided as recorded in study logs
Projection of Future Adoption
Time frame: 12 weeks
Number of participants (adolescent/caregiver dyads and individual young adults) who report they are likely or very likely to continue using the intervention during post-intervention, semi-structured interviews
Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 6 Weeks to 12 Weeks
Time frame: 6 weeks to 12 weeks
Number of participants (adolescent/caregiver dyads and young adults) who used the intervention from week 6 to week 12
Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 12 Weeks to 24 Weeks
Time frame: 12 weeks to 24 weeks
Number of participants (adolescent/caregiver dyads and young adults) who used the intervention from week 12 to week 24
Rate of Recruitment: Young Adults
Time frame: 6 months
Number of young adult participants recruited and enrolled per week. (Benchmark is 2 young adults recruited per week to reach a sample size of 15).
9 secondary outcomes
Difference in Mean Pain Score Rating From Baseline to End-of-Intervention
Time frame: baseline, 12 weeks
Difference in Mean Scores for Transition Readiness From Baseline to End-of-intervention
Time frame: baseline, 12 weeks
Difference in Mean Scores for Anxiety From Baseline to End-of-Intervention
Time frame: baseline, 12 weeks
Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-Intervention
Time frame: baseline, 12 weeks
Differences in Mean Scores for Pain Intensity From Baseline to End-of-interention
Time frame: baseline, 12 weeks
Difference in Mean Scores for Fatigue From Baseline to End-of-Intervention
Time frame: baseline, 12 weeks
Differences in Mean Scores for Quality of Life From Baseline to End-of-Intervention
Time frame: baseline, 12 weeks
Differences in Mean Scores for Condition-Specific Quality of Life From Baseline to End-of-Intervention
Time frame: baseline, 12 weeks
Difference in Mean Scores for Self-Efficacy From Baseline to End-of-Intervention
Time frame: baseline, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice Crisis Alert V2 in people with Sickle Cell Disease, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Recruitment: Dyads (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.