An interventional study of Voice Crisis Alert V2 in Sickle Cell Disease, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-11-19.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Supportive care
The purpose of this proposal is to integrate family-centered self-management strategies with mobile health (mHealth) technology to improve reach, self-management behaviors, and child and caregiver physical and psychosocial symptoms and quality of life. Specifically, the investigators propose to conduct feasibility testing of SMYLS, which has been adapted based on user feedback in the first phase of this study. First the investigators will work with the Medical University of South Carolina (MUSC) Pediatric Sickle Cell Clinic to identify and recruit families with children with sickle cell disease (SCD) in the community, statewide. Next, the investigators will test the feasibility of the intervention with 30 dyads of children ages 8 - 17 with sickle cell disease and their parent or primary caregiver, (N=60)
1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Voice Crisis Alert V2
Intervention consists of a mHealth app delivered via smartphone
Rates of Recruitment
Number of weeks required to recruit 30 participants.
Time frame: Assessed each week over a period of 6 months, cumulative data up to 6 months is reported.
Participant Adherence to Intervention
Number of participants who used the intervention (mHealth application) from baseline to mid-intervention, from mid-intervention to end-of-intervention, and from end-of-intervention to follow-up, assessed by number of participants who logged into and used the app, stored in the app's back end database.
Time frame: baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months
Acceptability of Intervention
Number of participants reporting problems with the intervention (mHealth app) per week.
Time frame: Assessed each week over a period of 6 months, cumulative data up to 6 months is reported.
Participant Adherence to Intervention
number of participants who accessed the educational component of intervention, assessed using back end app use database
Time frame: baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months
Participant Adherence to Intervention
Number of participants who accessed the symptom monitoring component of the intervention, assessed using the app back end database
Time frame: baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months
Participant Adherence to Intervention
number of participants who sent messages to nurse practitioner
Time frame: baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months
Difference in Mean Pain Score Rating From Baseline to End-of-intervention
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
Time frame: baseline, 12 weeks
Difference in Mean Caregiver Self-efficacy Score From Baseline to End-of-intervention
Self-efficacy for Managing Chronic Disease 6-item scale. Scores for each item range from 1 - 10 with 1 indicating lower confidence/self-efficacy and 10 indicating higher confidence/self-efficacy. Scores for each item are averaged for the mean total score. Change in score at 12 weeks minus baseline. Any increase in difference in mean scores = improved
Time frame: baseline, 12 weeks
Differences in Mean Scores for Quality of Life From Baseline to End-of-intervention
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
Time frame: baseline, 12 weeks
Difference in Mean Scores for Fatigue From Baseline to End-of-intervention
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
Time frame: baseline, 12 weeks
Difference in Mean Scores for Anxiety From Baseline to End-of-intervention
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
Time frame: baseline, 12 weeks
Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-intervention
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
Time frame: baseline,12 weeks
Differences in Mean Scores for Pain Intensity From Baseline to End-of-intervention
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
Time frame: baseline, 12 weeks
Differences in Mean Scores for Disease-related Quality of Life From Baseline to End-of-intervention
Pediatric Quality of Life Inventory (Peds QL) 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 between mean scores = improved
Time frame: baseline, 12 weeks
Clinic Appointment Attendance
Number of missed clinic appointments at baseline compared to 12 weeks
Time frame: 12 weeks
Home Medication Administration
Adherence to home medications, measured by number of medications marked as taken in the app database.
Time frame: 12 weeks
| Milestone | Group Receiving mHealth Intervention |
|---|---|
| Started | 30 |
| Mid-intervention assessment (6-weeks) | 25 |
| End-of-intervention assessment (12 weeks | 22 |
| 3-month post-intervention follow-up (6 m | 15 |
| Completed | 15 |
| Not completed | 15 |
Number of weeks required to recruit 30 participants.
| weeks | Intervention Group |
|---|---|
| Rates of Recruitment | 14 |
Number of participants who used the intervention (mHealth application) from baseline to mid-intervention, from mid-intervention to end-of-intervention, and from end-of-intervention to follow-up, assessed by number of participants who logged into and used the app, stored in the app's back end database.
| participants | Intervention Group |
|---|---|
| Number who used from baseline to 6 weeks | 30 |
| Number who used from 6 weeks to 12 weeks | 15 |
| Number who used from 12 weeks to 6 months | 10 |
Number of participants reporting problems with the intervention (mHealth app) per week.
| Participants | Intervention Group |
|---|---|
| Acceptability of Intervention | 4 |
number of participants who accessed the educational component of intervention, assessed using back end app use database
| participants | Intervention Group |
|---|---|
| Number who used from baseline to 6 weeks | 28 |
| Number who used from 6 weeks to 12 weeks | 7 |
| Number who used from 12 weeks to 6 months | 4 |
Number of participants who accessed the symptom monitoring component of the intervention, assessed using the app back end database
| participants | Intervention Group |
|---|---|
| Number who used from baseline to 6 weeks | 29 |
| Number who used from 6 weeks to 12 weeks | 15 |
| Number who used from 12 weeks to 6 months | 10 |
number of participants who sent messages to nurse practitioner
| participants | Intervention Group |
|---|---|
| Number who used from baseline to 6 weeks | 12 |
| Number who used from 6 weeks to 12 weeks | 2 |
| Number who used from 12 weeks to 6 months | 1 |
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
| scores on scale | Group Receiving mHealth Intervention |
|---|---|
| Difference in Mean Pain Score Rating From Baseline to End-of-intervention | -9.0 (-15.0 to -3.0) |
Self-efficacy for Managing Chronic Disease 6-item scale. Scores for each item range from 1 - 10 with 1 indicating lower confidence/self-efficacy and 10 indicating higher confidence/self-efficacy. Scores for each item are averaged for the mean total score. Change in score at 12 weeks minus baseline. Any increase in difference in mean scores = improved
| scores on scale | Group Receiving mHealth Intervention |
|---|---|
| Difference in Mean Caregiver Self-efficacy Score From Baseline to End-of-intervention | 0.2 (-0.5 to 0.9) |
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
| scores on scale | Group Receiving mHealth Intervention |
|---|---|
| Differences in Mean Scores for Quality of Life From Baseline to End-of-intervention | 10.9 (4.3 to 17.4) |
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
| scores on scale | Group Receiving mHealth Intervention |
|---|---|
| Difference in Mean Scores for Fatigue From Baseline to End-of-intervention | -7.9 (-12.9 to -2.9) |
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
| scores on scale | Group Receiving mHealth Intervention |
|---|---|
| Difference in Mean Scores for Anxiety From Baseline to End-of-intervention | 1.6 (-3.7 to 6.8) |
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
| scores on scale | Group Receiving mHealth Intervention |
|---|---|
| Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-intervention | -3.1 (-7.3 to 1.1) |
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
| scores on scale | Group Receiving mHealth Intervention |
|---|---|
| Differences in Mean Scores for Pain Intensity From Baseline to End-of-intervention | -1.9 (-4.4 to 0.6) |
Pediatric Quality of Life Inventory (Peds QL) 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 between mean scores = improved
| scores on scale | Group Receiving mHealth Intervention |
|---|---|
| Differences in Mean Scores for Disease-related Quality of Life From Baseline to End-of-intervention | 12.5 (7.1 to 17.9) |
Number of missed clinic appointments at baseline compared to 12 weeks
No measurements were reported for this outcome.
Adherence to home medications, measured by number of medications marked as taken in the app database.
No measurements were reported for this outcome.
Collected over The duration of study participation; 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 0/30 (0%) | 2/30 (6.7%) | 0/30 (0%) |
| Event | Intervention Group |
|---|---|
| Vaso-occlusive crisisBlood and lymphatic system disorders | 2/30 |
| Age, Continuous(years) | Intervention Group |
|---|---|
| Mean | 11.8 ± 2.9 |
| Sex: Female, Male(Participants) | Intervention Group |
|---|---|
| Female | 14 |
| Male | 16 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Group |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 30 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Intervention Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 30 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Intervention Group |
|---|---|
| United States | 30 |
| Parent/caregiver type(Participants) | Intervention Group |
|---|---|
| mother | 27 |
| father | 1 |
| grandmother | 2 |
| Parent/caregiver employment status(Participants) | Intervention Group |
|---|---|
| employed | 21 |
| caregiver/stay-at-home parent | 2 |
| unemployed | 3 |
| student | 0 |
| disabled | 0 |
| unknown/no response | 4 |
| Parent/caregiver education level(Participants) | Intervention Group |
|---|---|
| 9 - 12 grade or less | 3 |
| high school graduate or GED | 5 |
| some college or certification course | 13 |
| college graduate or above | 9 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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Medical University of South Carolina