Sickle Cell Disease
Conditions
Brief 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.
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).
Interventions
BEHAVIORALVoice 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).
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Recruitment: Dyads | 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 | 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 | 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 | 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 | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Mean Scores for Condition-Specific Quality of Life From Baseline to End-of-Intervention | baseline, 12 weeks | 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. |
| Difference in Mean Pain Score Rating From Baseline to End-of-Intervention | baseline, 12 weeks | 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 |
| Difference in Mean Scores for Self-Efficacy From Baseline to End-of-Intervention | baseline, 12 weeks | 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 |
| Difference in Mean Scores for Transition Readiness From Baseline to End-of-intervention | baseline, 12 weeks | 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 |
| Difference in Mean Scores for Anxiety From Baseline to End-of-Intervention | baseline, 12 weeks | 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 |
| Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-Intervention | baseline, 12 weeks | 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 |
| Differences in Mean Scores for Pain Intensity From Baseline to End-of-interention | baseline, 12 weeks | 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. |
| Difference in Mean Scores for Fatigue From Baseline to End-of-Intervention | baseline, 12 weeks | 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 |
| Differences in Mean Scores for Quality of Life From Baseline to End-of-Intervention | baseline, 12 weeks | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm: Adolescents 11-17 Years 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). | 30 |
| Intervention Arm: Caregivers 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). | 30 |
| Intervention Arm: Young Adults 18 - 25 Years 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). | 15 |
| Healthcare Providers 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). | 5 |
| Total | 80 |
Baseline characteristics
| Characteristic | Total | Intervention Arm: Adolescents 11-17 Years | Intervention Arm: Caregivers | Intervention Arm: Young Adults 18 - 25 Years | Healthcare Providers |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 30 Participants | 0 Participants | 0 Participants | — |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 43 Participants | 0 Participants | 28 Participants | 15 Participants | — |
| Age, Continuous | 26 years STANDARD_DEVIATION 14.7 | 13.8 years STANDARD_DEVIATION 4.7 | 42.6 years STANDARD_DEVIATION 10.1 | 20 years STANDARD_DEVIATION 2.1 | — |
| Education level 8th grade or less | 17 Participants | 16 Participants | 1 Participants | 0 Participants | — |
| Education level College graduate | 7 Participants | 0 Participants | 7 Participants | 0 Participants | — |
| Education level High school graduate | 13 Participants | 0 Participants | 6 Participants | 7 Participants | — |
| Education level missing | 2 Participants | 1 Participants | 1 Participants | 0 Participants | — |
| Education level Post graduate or higher level degree | 4 Participants | 0 Participants | 4 Participants | 0 Participants | — |
| Education level Some college | 13 Participants | 0 Participants | 9 Participants | 4 Participants | — |
| Education level Some high school | 19 Participants | 13 Participants | 2 Participants | 4 Participants | — |
| Employment status Full-time | 25 Participants | 0 Participants | 19 Participants | 1 Participants | 5 Participants |
| Employment status missing | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Employment status Not employed | 10 Participants | 0 Participants | 4 Participants | 6 Participants | 0 Participants |
| Employment status Part-time | 8 Participants | 0 Participants | 4 Participants | 4 Participants | 0 Participants |
| Employment status Retired | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Employment status Student | 33 Participants | 30 Participants | 0 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 78 Participants | 29 Participants | 30 Participants | 14 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Household size 1 | 2 Participants | 1 Participants | 1 Participants | 0 Participants | — |
| Household size 2 | 6 Participants | 2 Participants | 2 Participants | 2 Participants | — |
| Household size 3 | 18 Participants | 8 Participants | 8 Participants | 2 Participants | — |
| Household size 4 | 22 Participants | 7 Participants | 7 Participants | 8 Participants | — |
| Household size 5 | 17 Participants | 8 Participants | 8 Participants | 1 Participants | — |
| Household size 6 | 4 Participants | 1 Participants | 1 Participants | 2 Participants | — |
| Household size 7 | 2 Participants | 1 Participants | 1 Participants | 0 Participants | — |
| Household size Missing | 2 Participants | 1 Participants | 1 Participants | 0 Participants | — |
| Household size Prefer not to respond | 2 Participants | 1 Participants | 1 Participants | 0 Participants | — |
| Marital status Divorced | 2 Participants | 0 Participants | 2 Participants | 0 Participants | — |
| Marital status Married | 8 Participants | 0 Participants | 8 Participants | 0 Participants | — |
| Marital status Missing | 1 Participants | 0 Participants | 1 Participants | 0 Participants | — |
| Marital status Never married | 59 Participants | 30 Participants | 16 Participants | 13 Participants | — |
| Marital status Prefer not to respond | 2 Participants | 0 Participants | 1 Participants | 1 Participants | — |
| Marital status Resides with SO | 1 Participants | 0 Participants | 0 Participants | 1 Participants | — |
| Marital status Separated | 1 Participants | 0 Participants | 1 Participants | 0 Participants | — |
| Marital status Widowed | 1 Participants | 0 Participants | 1 Participants | 0 Participants | — |
| Number of individual children (<18 years) with SCD seen in the past 12 months 200 - 300 | 2 Participants | — | — | — | 2 Participants |
| Number of individual children (<18 years) with SCD seen in the past 12 months Less than 200 | 1 Participants | — | — | — | 1 Participants |
| Number of individual children (<18 years) with SCD seen in the past 12 months More than 300 | 2 Participants | — | — | — | 2 Participants |
| Parent/caregiver type Grandmother | 1 Participants | — | 1 Participants | — | — |
| Parent/caregiver type missing | 2 Participants | — | 2 Participants | — | — |
| Parent/caregiver type Mother | 27 Participants | — | 27 Participants | — | — |
| Primary specialty or subspecialty Hematology | 3 Participants | — | — | — | 3 Participants |
| Primary specialty or subspecialty Hematology/Oncology | 2 Participants | — | — | — | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 74 Participants | 29 Participants | 28 Participants | 15 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Region of Enrollment United States | 80 participants | 30 participants | 30 participants | 15 participants | 5 participants |
| Sex: Female, Male Female | 58 Participants | 14 Participants | 30 Participants | 9 Participants | 5 Participants |
| Sex: Female, Male Male | 22 Participants | 16 Participants | 0 Participants | 6 Participants | 0 Participants |
| Type of licensed provider Medical Doctor | 2 Participants | — | — | — | 2 Participants |
| Type of licensed provider Nurse Practitioner | 2 Participants | — | — | — | 2 Participants |
| Type of licensed provider Physician Assistant | 1 Participants | — | — | — | 1 Participants |
| Years' experience caring for individuals with SCD 10 - 20 years | 1 Participants | — | — | — | 1 Participants |
| Years' experience caring for individuals with SCD 20 or more years | 3 Participants | — | — | — | 3 Participants |
| Years' experience caring for individuals with SCD Less than 10 years | 1 Participants | — | — | — | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 15 | 0 / 5 |
| other Total, other adverse events | 1 / 30 | 0 / 30 | 0 / 15 | 0 / 5 |
| serious Total, serious adverse events | 5 / 30 | 0 / 30 | 0 / 15 | 0 / 5 |
Outcome results
Primary
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
Time frame: 24 weeks
Population: Healthcare providers did not receive the intervention and are not included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adolescent/Caregiver Dyads | Consistency of Intervention Delivery | 30 Participants |
| Young Adults | Consistency of Intervention Delivery | 15 Participants |
Primary
Participant Adherence to the Intervention
Number of participants (adolescent/caregiver dyads and young adults) using the app from baseline to 6 weeks
Time frame: baseline to 6 weeks
Population: Healthcare providers did not receive the intervention and are not included in this variable
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adolescent/Caregiver Dyads | Participant Adherence to the Intervention | 24 Participants |
| Young Adults | Participant Adherence to the Intervention | 12 Participants |
Primary
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
Time frame: 12 weeks to 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adolescent/Caregiver Dyads | Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 12 Weeks to 24 Weeks | 12 Participants |
| Young Adults | Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 12 Weeks to 24 Weeks | 4 Participants |
Primary
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
Time frame: 6 weeks to 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adolescent/Caregiver Dyads | Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 6 Weeks to 12 Weeks | 16 Participants |
| Young Adults | Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 6 Weeks to 12 Weeks | 8 Participants |
Primary
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
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adolescent/Caregiver Dyads | Projection of Future Adoption | 12 Participants |
| Young Adults | Projection of Future Adoption | 9 Participants |
Primary
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)
Time frame: 6 months
Population: Healthcare providers: Variable not assessed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adolescent/Caregiver Dyads | Rate of Recruitment: Dyads | 2 dyads recruited and enrolled/week |
Primary
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).
Time frame: 6 months
Population: Healthcare providers: variable not assessed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Young Adults | Rate of Recruitment: Young Adults | 4 young adults recruited and enrolled/week |
Secondary
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
Time frame: baseline, 12 weeks
Population: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adolescent/Caregiver Dyads | Difference in Mean Pain Score Rating From Baseline to End-of-Intervention | -8.5 scores on scale |
| Young Adults | Difference in Mean Pain Score Rating From Baseline to End-of-Intervention | -6.8 scores on scale |
Secondary
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
Time frame: baseline, 12 weeks
Population: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adolescent/Caregiver Dyads | Difference in Mean Scores for Anxiety From Baseline to End-of-Intervention | -1.5 scores on scale |
| Young Adults | Difference in Mean Scores for Anxiety From Baseline to End-of-Intervention | 2.3 scores on scale |
| Caregivers | Difference in Mean Scores for Anxiety From Baseline to End-of-Intervention | -0.2 scores on scale |
Secondary
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
Time frame: baseline, 12 weeks
Population: Healthcare providers: Variable not assessed
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adolescent/Caregiver Dyads | Difference in Mean Scores for Fatigue From Baseline to End-of-Intervention | -0.7 score on a scale |
| Young Adults | Difference in Mean Scores for Fatigue From Baseline to End-of-Intervention | -5.2 score on a scale |
| Caregivers | Difference in Mean Scores for Fatigue From Baseline to End-of-Intervention | 2.3 score on a scale |
Secondary
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
Time frame: baseline, 12 weeks
Population: Caregivers: variable not assessed Healthcare providers: variable not assessed
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adolescent/Caregiver Dyads | Difference in Mean Scores for Self-Efficacy From Baseline to End-of-Intervention | -0.6 score on a scale |
| Young Adults | Difference in Mean Scores for Self-Efficacy From Baseline to End-of-Intervention | 0.4 score on a scale |
Secondary
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
Time frame: baseline, 12 weeks
Population: Caregivers: variable not assessed Healthcare providers: variable not assessed
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adolescent/Caregiver Dyads | Difference in Mean Scores for Transition Readiness From Baseline to End-of-intervention | 0.6 score on a scale |
| Young Adults | Difference in Mean Scores for Transition Readiness From Baseline to End-of-intervention | 1.2 score on a scale |
Secondary
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.
Time frame: baseline, 12 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Adolescent/Caregiver Dyads | 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 |
| Young Adults | 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 |
| Young Adults | 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 |
| Young Adults | 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 |
| Young Adults | 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 |
| Young Adults | 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 |
Secondary
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.
Time frame: baseline, 12 weeks
Population: Caregivers: Variable not assessed Healthcare providers: Variable not assessed
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adolescent/Caregiver Dyads | Differences in Mean Scores for Pain Intensity From Baseline to End-of-interention | -2.7 score on a scale |
| Young Adults | Differences in Mean Scores for Pain Intensity From Baseline to End-of-interention | -3.8 score on a scale |
Secondary
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
Time frame: baseline, 12 weeks
Population: Young Adults: Only condition-specific health-related quality of life was assessed and is reported in outcome number 14.~Healthcare providers: variable not assessed
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adolescent/Caregiver Dyads | Differences in Mean Scores for Quality of Life From Baseline to End-of-Intervention | 0.9 score on a scale |
| Young Adults | Differences in Mean Scores for Quality of Life From Baseline to End-of-Intervention | -3.4 score on a scale |
Secondary
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
Time frame: baseline, 12 weeks
Population: Healthcare providers: Variable not assessed
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adolescent/Caregiver Dyads | Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-Intervention | -1.4 score on a scale |
| Young Adults | Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-Intervention | -2.2 score on a scale |
| Caregivers | Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-Intervention | 0.8 score on a scale |