Trial Outcomes & Findings for SMYLS: A Self-management Program for Youth Living With Sickle Cell Disease (NCT NCT04289311)
NCT ID: NCT04289311
Last Updated: 2024-08-16
Results Overview
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)
COMPLETED
NA
30 participants
6 months
2024-08-16
Participant Flow
Adolescents ages 11 - 17 were enrolled as a dyad with a parent or primary caregiver (n = 30 dyads). 15 young adults ages 18 - 25 were enrolled as individuals. 5 SCD healthcare providers were enrolled.
Participant milestones
| Measure |
Intervention Arm: Adolescents 11 - 17 Years
Single group study; all participants are in the intervention arm and receive the intervention. Arms are designated for adolescents 11 - 17, caregivers of adolescents, young adults 18 - 25, and healthcare providers.
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).
|
Intervention Arm: Caregivers
Single group study; all participants are in the intervention arm and receive the intervention. Arms are designated for adolescents 11 - 17, caregivers of adolescents, young adults 18 - 25, and healthcare providers.
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).
|
Intervention Arm: Young Adults 18 - 25 Years
Single group study; all participants are in the intervention arm and receive the intervention. Arms are designated for adolescents 11 - 17, caregivers of adolescents, young adults 18 - 25, and healthcare providers.
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).
|
Healthcare Providers
Single group study; all participants are in the intervention arm and receive the intervention. Arms are designated for adolescents 11 - 17, caregivers of adolescents, young adults 18 - 25, and healthcare providers.
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).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
15
|
5
|
|
Overall Study
Mid-intervention Assessment (6 Weeks)
|
25
|
25
|
15
|
5
|
|
Overall Study
End-of-intervention Assessment (12 Weeks)
|
26
|
26
|
15
|
5
|
|
Overall Study
Post-intervention Follow up (24 Weeks)
|
24
|
24
|
15
|
5
|
|
Overall Study
COMPLETED
|
24
|
24
|
15
|
5
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Healthcare providers were not assessed for this baseline measure.
Baseline characteristics by cohort
| Measure |
Intervention Arm: Adolescents 11-17 Years
n=30 Participants
Single group study; all participants are in the intervention arm and receive the intervention. Adolescents 11 - 17 years were enrolled as dyads with a parent/primary caregiver (n = 30), young adults were enrolled individually (n = 15), and 5 SCD healthcare providers were enrolled.
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).
|
Intervention Arm: Caregivers
n=30 Participants
Single group study; all participants are in the intervention arm and receive the intervention. Adolescents 11 - 17 years were enrolled as dyads with a parent/primary caregiver (n = 30), young adults were enrolled individually (n = 15), and 5 SCD healthcare providers were enrolled.
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).
|
Intervention Arm: Young Adults 18 - 25 Years
n=15 Participants
Single group study; all participants are in the intervention arm and receive the intervention. Adolescents 11 - 17 years were enrolled as dyads with a parent/primary caregiver (n = 30), young adults were enrolled individually (n = 15), and 5 SCD healthcare providers were enrolled.
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).
|
Healthcare Providers
n=5 Participants
Single group study; all participants are in the intervention arm and receive the intervention. Adolescents 11 - 17 years were enrolled as dyads with a parent/primary caregiver (n = 30), young adults were enrolled individually (n = 15), and 5 SCD healthcare providers were enrolled.
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).
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
0 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
0 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
30 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
28 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
15 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
43 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
2 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
0 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
2 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Age, Continuous
|
13.8 years
STANDARD_DEVIATION 4.7 • n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
42.6 years
STANDARD_DEVIATION 10.1 • n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
20 years
STANDARD_DEVIATION 2.1 • n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
26 years
STANDARD_DEVIATION 14.7 • n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Sex: Female, Male
Female
|
14 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
9 Participants
n=15 Participants
|
5 Participants
n=5 Participants
|
58 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
6 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
22 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
14 Participants
n=15 Participants
|
5 Participants
n=5 Participants
|
78 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=30 Participants
|
28 Participants
n=30 Participants
|
15 Participants
n=15 Participants
|
2 Participants
n=5 Participants
|
74 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=15 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=80 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=30 Participants
|
30 participants
n=30 Participants
|
15 participants
n=15 Participants
|
5 participants
n=5 Participants
|
80 participants
n=80 Participants
|
|
Parent/caregiver type
Mother
|
—
|
27 Participants
n=30 Participants • Healthcare providers, Adolescents, and Young Adults were not assessed for this baseline measure.
|
—
|
—
|
27 Participants
n=30 Participants • Healthcare providers, Adolescents, and Young Adults were not assessed for this baseline measure.
|
|
Parent/caregiver type
Grandmother
|
—
|
1 Participants
n=30 Participants • Healthcare providers, Adolescents, and Young Adults were not assessed for this baseline measure.
|
—
|
—
|
1 Participants
n=30 Participants • Healthcare providers, Adolescents, and Young Adults were not assessed for this baseline measure.
|
|
Parent/caregiver type
missing
|
—
|
2 Participants
n=30 Participants • Healthcare providers, Adolescents, and Young Adults were not assessed for this baseline measure.
|
—
|
—
|
2 Participants
n=30 Participants • Healthcare providers, Adolescents, and Young Adults were not assessed for this baseline measure.
|
|
Employment status
Full-time
|
0 Participants
n=30 Participants
|
19 Participants
n=30 Participants
|
1 Participants
n=15 Participants
|
5 Participants
n=5 Participants
|
25 Participants
n=80 Participants
|
|
Employment status
Part-time
|
0 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=80 Participants
|
|
Employment status
Not employed
|
0 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
6 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=80 Participants
|
|
Employment status
Retired
|
0 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=80 Participants
|
|
Employment status
missing
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=80 Participants
|
|
Employment status
Student
|
30 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
33 Participants
n=80 Participants
|
|
Education level
8th grade or less
|
16 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
1 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
0 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
17 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Education level
Some high school
|
13 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
2 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
4 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
19 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Education level
High school graduate
|
0 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
6 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
7 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
13 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Education level
Some college
|
0 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
9 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
4 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
13 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Education level
College graduate
|
0 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
7 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
0 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
7 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Education level
Post graduate or higher level degree
|
0 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
4 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
0 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
4 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Education level
missing
|
1 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
1 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
0 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
2 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Marital status
Never married
|
30 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
16 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
13 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
59 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Marital status
Married
|
0 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
8 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
0 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
8 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Marital status
Widowed
|
0 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
1 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
0 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
1 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Marital status
Separated
|
0 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
1 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
0 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
1 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Marital status
Divorced
|
0 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
2 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
0 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
2 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Marital status
Prefer not to respond
|
0 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
1 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
1 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
2 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Marital status
Missing
|
0 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
1 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
0 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
1 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Marital status
Resides with SO
|
0 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
0 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
1 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
1 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Household size
1
|
1 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
1 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
0 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
2 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Household size
2
|
2 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
2 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
2 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
6 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Household size
3
|
8 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
8 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
2 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
18 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Household size
4
|
7 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
7 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
8 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
22 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Household size
5
|
8 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
8 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
1 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
17 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Household size
6
|
1 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
1 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
2 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
4 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Household size
7
|
1 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
1 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
0 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
2 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Household size
Prefer not to respond
|
1 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
1 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
0 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
2 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Household size
Missing
|
1 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
1 Participants
n=30 Participants • Healthcare providers were not assessed for this baseline measure.
|
0 Participants
n=15 Participants • Healthcare providers were not assessed for this baseline measure.
|
—
|
2 Participants
n=75 Participants • Healthcare providers were not assessed for this baseline measure.
|
|
Type of licensed provider
Nurse Practitioner
|
—
|
—
|
—
|
2 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
2 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
|
Type of licensed provider
Medical Doctor
|
—
|
—
|
—
|
2 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
2 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
|
Type of licensed provider
Physician Assistant
|
—
|
—
|
—
|
1 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
1 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
|
Primary specialty or subspecialty
Hematology
|
—
|
—
|
—
|
3 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
3 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
|
Primary specialty or subspecialty
Hematology/Oncology
|
—
|
—
|
—
|
2 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
2 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
|
Years' experience caring for individuals with SCD
Less than 10 years
|
—
|
—
|
—
|
1 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
1 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
|
Years' experience caring for individuals with SCD
10 - 20 years
|
—
|
—
|
—
|
1 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
1 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
|
Years' experience caring for individuals with SCD
20 or more years
|
—
|
—
|
—
|
3 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
3 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
|
Number of individual children (<18 years) with SCD seen in the past 12 months
Less than 200
|
—
|
—
|
—
|
1 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
1 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
|
Number of individual children (<18 years) with SCD seen in the past 12 months
200 - 300
|
—
|
—
|
—
|
2 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
2 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
|
Number of individual children (<18 years) with SCD seen in the past 12 months
More than 300
|
—
|
—
|
—
|
2 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
2 Participants
n=5 Participants • Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure.
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Healthcare providers: Variable not assessed
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)
Outcome measures
| Measure |
Adolescent/Caregiver Dyads
n=30 Participants
Adolescent/caregiver dyads receiving intervention
|
Young Adults
Individual young adults receiving intervention
|
Caregivers
Caregivers participating as a dyad with adolescent
|
|---|---|---|---|
|
Rate of Recruitment: Dyads
|
2 dyads recruited and enrolled/week
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline to 6 weeksPopulation: Healthcare providers did not receive the intervention and are not included in this variable
Number of participants (adolescent/caregiver dyads and young adults) using the app from baseline to 6 weeks
Outcome measures
| Measure |
Adolescent/Caregiver Dyads
n=30 Participants
Adolescent/caregiver dyads receiving intervention
|
Young Adults
n=15 Participants
Individual young adults receiving intervention
|
Caregivers
Caregivers participating as a dyad with adolescent
|
|---|---|---|---|
|
Participant Adherence to the Intervention
|
24 Participants
|
12 Participants
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Healthcare providers did not receive the intervention and are not included.
Number of participants (adolescent/caregiver dyads and young adults) to whom instructions on the intervention were provided as recorded in study logs
Outcome measures
| Measure |
Adolescent/Caregiver Dyads
n=30 Participants
Adolescent/caregiver dyads receiving intervention
|
Young Adults
n=15 Participants
Individual young adults receiving intervention
|
Caregivers
Caregivers participating as a dyad with adolescent
|
|---|---|---|---|
|
Consistency of Intervention Delivery
|
30 Participants
|
15 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 12 dyads who completed end-of-intervention interview 10 young adults who completed end-of-intervention interview Healthcare providers did not receive the intervention and are not included.
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
Outcome measures
| Measure |
Adolescent/Caregiver Dyads
n=12 Participants
Adolescent/caregiver dyads receiving intervention
|
Young Adults
n=10 Participants
Individual young adults receiving intervention
|
Caregivers
Caregivers participating as a dyad with adolescent
|
|---|---|---|---|
|
Projection of Future Adoption
|
12 Participants
|
9 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 weeks to 12 weeksNumber of participants (adolescent/caregiver dyads and young adults) who used the intervention from week 6 to week 12
Outcome measures
| Measure |
Adolescent/Caregiver Dyads
n=30 Participants
Adolescent/caregiver dyads receiving intervention
|
Young Adults
n=15 Participants
Individual young adults receiving intervention
|
Caregivers
Caregivers participating as a dyad with adolescent
|
|---|---|---|---|
|
Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 6 Weeks to 12 Weeks
|
16 Participants
|
8 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 weeks to 24 weeksNumber of participants (adolescent/caregiver dyads and young adults) who used the intervention from week 12 to week 24
Outcome measures
| Measure |
Adolescent/Caregiver Dyads
n=30 Participants
Adolescent/caregiver dyads receiving intervention
|
Young Adults
n=15 Participants
Individual young adults receiving intervention
|
Caregivers
Caregivers participating as a dyad with adolescent
|
|---|---|---|---|
|
Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 12 Weeks to 24 Weeks
|
12 Participants
|
4 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Healthcare providers: variable not assessed
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).
Outcome measures
| Measure |
Adolescent/Caregiver Dyads
Adolescent/caregiver dyads receiving intervention
|
Young Adults
n=15 Participants
Individual young adults receiving intervention
|
Caregivers
Caregivers participating as a dyad with adolescent
|
|---|---|---|---|
|
Rate of Recruitment: Young Adults
|
—
|
4 young adults recruited and enrolled/week
|
—
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: Adolescents: 26 participants retained to 12 weeks (end-of-intervention) for analysis Young adults: 15 participants retained to 12 weeks (end-of-intervention) for analysis Caregivers: Variable not assessed Healthcare providers: Variable not assessed
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
Outcome measures
| Measure |
Adolescent/Caregiver Dyads
n=26 Participants
Adolescent/caregiver dyads receiving intervention
|
Young Adults
n=15 Participants
Individual young adults receiving intervention
|
Caregivers
Caregivers participating as a dyad with adolescent
|
|---|---|---|---|
|
Difference in Mean Pain Score Rating From Baseline to End-of-Intervention
|
-8.5 scores on scale
Interval -13.9 to -3.2
|
-6.8 scores on scale
Interval -11.5 to -2.1
|
—
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: Caregivers: variable not assessed Healthcare providers: variable not assessed
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
Outcome measures
| Measure |
Adolescent/Caregiver Dyads
n=26 Participants
Adolescent/caregiver dyads receiving intervention
|
Young Adults
n=15 Participants
Individual young adults receiving intervention
|
Caregivers
Caregivers participating as a dyad with adolescent
|
|---|---|---|---|
|
Difference in Mean Scores for Transition Readiness From Baseline to End-of-intervention
|
0.6 score on a scale
Interval -2.8 to 4.0
|
1.2 score on a scale
Interval -2.2 to 4.6
|
—
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: Adolescents and caregivers: 26 dyads retained to 12 weeks and included in the analysis Young adults: 15 participants retained to 12 weeks and included in the analysis Healthcare providers: Variable not assessed
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
Outcome measures
| Measure |
Adolescent/Caregiver Dyads
n=26 Participants
Adolescent/caregiver dyads receiving intervention
|
Young Adults
n=15 Participants
Individual young adults receiving intervention
|
Caregivers
n=26 Participants
Caregivers participating as a dyad with adolescent
|
|---|---|---|---|
|
Difference in Mean Scores for Anxiety From Baseline to End-of-Intervention
|
-1.5 scores on scale
Interval -5.7 to 2.8
|
2.3 scores on scale
Interval -1.8 to 6.4
|
-0.2 scores on scale
Interval -4.8 to 4.4
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: Healthcare providers: Variable not assessed
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
Outcome measures
| Measure |
Adolescent/Caregiver Dyads
n=26 Participants
Adolescent/caregiver dyads receiving intervention
|
Young Adults
n=15 Participants
Individual young adults receiving intervention
|
Caregivers
n=26 Participants
Caregivers participating as a dyad with adolescent
|
|---|---|---|---|
|
Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-Intervention
|
-1.4 score on a scale
Interval -5.4 to 2.6
|
-2.2 score on a scale
Interval -7.5 to 3.1
|
0.8 score on a scale
Interval -2.1 to 3.8
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: Caregivers: Variable not assessed Healthcare providers: Variable not assessed
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.
Outcome measures
| Measure |
Adolescent/Caregiver Dyads
n=26 Participants
Adolescent/caregiver dyads receiving intervention
|
Young Adults
n=15 Participants
Individual young adults receiving intervention
|
Caregivers
Caregivers participating as a dyad with adolescent
|
|---|---|---|---|
|
Differences in Mean Scores for Pain Intensity From Baseline to End-of-interention
|
-2.7 score on a scale
Interval -7.1 to 1.8
|
-3.8 score on a scale
Interval -9.0 to 1.5
|
—
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: Healthcare providers: Variable not assessed
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
Outcome measures
| Measure |
Adolescent/Caregiver Dyads
n=26 Participants
Adolescent/caregiver dyads receiving intervention
|
Young Adults
n=15 Participants
Individual young adults receiving intervention
|
Caregivers
n=26 Participants
Caregivers participating as a dyad with adolescent
|
|---|---|---|---|
|
Difference in Mean Scores for Fatigue From Baseline to End-of-Intervention
|
-0.7 score on a scale
Interval -3.8 to 2.5
|
-5.2 score on a scale
Interval -9.8 to -0.6
|
2.3 score on a scale
Interval -1.1 to 5.8
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: Young Adults: Only condition-specific health-related quality of life was assessed and is reported in outcome number 14. Healthcare providers: variable not assessed
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
Outcome measures
| Measure |
Adolescent/Caregiver Dyads
n=26 Participants
Adolescent/caregiver dyads receiving intervention
|
Young Adults
n=26 Participants
Individual young adults receiving intervention
|
Caregivers
Caregivers participating as a dyad with adolescent
|
|---|---|---|---|
|
Differences in Mean Scores for Quality of Life From Baseline to End-of-Intervention
|
0.9 score on a scale
Interval -4.1 to 6.0
|
-3.4 score on a scale
Interval -6.2 to -0.6
|
—
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: Caregivers: variable not assessed Healthcare providers: variable not assessed Young adults were not assessed with the PedsQL SCDM and adolescents were not assessed with the ASCQ-Me.
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.
Outcome measures
| Measure |
Adolescent/Caregiver Dyads
n=26 Participants
Adolescent/caregiver dyads receiving intervention
|
Young Adults
n=15 Participants
Individual young adults receiving intervention
|
Caregivers
Caregivers participating as a dyad with adolescent
|
|---|---|---|---|
|
Differences in Mean Scores for Condition-Specific Quality of Life From Baseline to End-of-Intervention
ASCQ-Me Stiffness Impact
|
—
|
3.1 score on a scale
Interval -1.9 to 8.0
|
—
|
|
Differences in Mean Scores for Condition-Specific Quality of Life From Baseline to End-of-Intervention
ASCQ-Me Pain Impact
|
—
|
6.1 score on a scale
Interval 1.7 to 10.5
|
—
|
|
Differences in Mean Scores for Condition-Specific Quality of Life From Baseline to End-of-Intervention
PedsQL SCDM Total score
|
7.2 score on a scale
Interval 2.6 to 11.9
|
—
|
—
|
|
Differences in Mean Scores for Condition-Specific Quality of Life From Baseline to End-of-Intervention
ASCQ-Me Emotional Impact
|
—
|
2.2 score on a scale
Interval 0.0 to 4.3
|
—
|
|
Differences in Mean Scores for Condition-Specific Quality of Life From Baseline to End-of-Intervention
ASCQ-Me Social Impact
|
—
|
7.4 score on a scale
Interval 2.3 to 12.4
|
—
|
|
Differences in Mean Scores for Condition-Specific Quality of Life From Baseline to End-of-Intervention
ASCQ-Me Sleep Impact
|
—
|
2.7 score on a scale
Interval -1.0 to 6.4
|
—
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: Caregivers: variable not assessed Healthcare providers: variable not assessed
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
Outcome measures
| Measure |
Adolescent/Caregiver Dyads
n=26 Participants
Adolescent/caregiver dyads receiving intervention
|
Young Adults
n=15 Participants
Individual young adults receiving intervention
|
Caregivers
Caregivers participating as a dyad with adolescent
|
|---|---|---|---|
|
Difference in Mean Scores for Self-Efficacy From Baseline to End-of-Intervention
|
-0.6 score on a scale
Interval -4.4 to 3.1
|
0.4 score on a scale
Interval -4.2 to 5.0
|
—
|
Adverse Events
Adolescents
Caregivers
Young Adults
Healthcare Providers
Serious adverse events
| Measure |
Adolescents
n=30 participants at risk
Adolescents ages 11 - 17 years receiving intervention
|
Caregivers
n=30 participants at risk
Caregivers of adolescents participating as a dyad
|
Young Adults
n=15 participants at risk
Young adults ages 18 - 25 receiving intervention
|
Healthcare Providers
n=5 participants at risk
Healthcare providers participating in study
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hospitalization for vasoocclusive episode
|
16.7%
5/30 • Number of events 7 • Duration of study participation: 24 weeks
|
0.00%
0/30 • Duration of study participation: 24 weeks
|
0.00%
0/15 • Duration of study participation: 24 weeks
|
0.00%
0/5 • Duration of study participation: 24 weeks
|
Other adverse events
| Measure |
Adolescents
n=30 participants at risk
Adolescents ages 11 - 17 years receiving intervention
|
Caregivers
n=30 participants at risk
Caregivers of adolescents participating as a dyad
|
Young Adults
n=15 participants at risk
Young adults ages 18 - 25 receiving intervention
|
Healthcare Providers
n=5 participants at risk
Healthcare providers participating in study
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Vasoocclusive episode without hospitalization
|
3.3%
1/30 • Number of events 2 • Duration of study participation: 24 weeks
|
0.00%
0/30 • Duration of study participation: 24 weeks
|
0.00%
0/15 • Duration of study participation: 24 weeks
|
0.00%
0/5 • Duration of study participation: 24 weeks
|
Additional Information
Shannon Phillips, PhD, RN, Associate Professor
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place