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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Single group study; all participants are in the intervention arm and receive the intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voice Crisis Alert V2 | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 months |
| Participant Adherence to the Intervention | Number of participants (adolescent/caregiver dyads and young adults) using the app from baseline to 6 weeks | baseline to 6 weeks |
| Consistency of Intervention Delivery | Number of participants (adolescent/caregiver dyads and young adults) to whom instructions on the intervention were provided as recorded in study logs | 24 weeks |
| Projection of Future Adoption | Number of participants (adolescent/caregiver dyads and individual young adults) who report they are likely or very likely to continue using the intervention during post-intervention, semi-structured interviews | 12 weeks |
| Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 6 Weeks to 12 Weeks | Number of participants (adolescent/caregiver dyads and young adults) who used the intervention from week 6 to week 12 | 6 weeks to 12 weeks |
| Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 12 Weeks to 24 Weeks | Number of participants (adolescent/caregiver dyads and young adults) who used the intervention from week 12 to week 24 | 12 weeks to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| FG002 | 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). |
| FG003 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Healthcare providers were not assessed for this baseline measure. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Healthcare providers: Variable not assessed | Posted | Number | dyads recruited and enrolled/week | 6 months |
|
Duration of study participation: 24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adolescents | Adolescents ages 11 - 17 years receiving intervention | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for vasoocclusive episode | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vasoocclusive episode without hospitalization | Blood and lymphatic system disorders | Non-systematic Assessment |
Limitations of this feasibility study included measurement issues with the clinic appointment attendance. We were unable to assess this outcome measure with accuracy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shannon Phillips, PhD, RN, Associate Professor | Medical University of South Carolina | 843-792-9379 | phillipss@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 14, 2021 | Jun 30, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 25, 2020 | Jun 30, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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|
| 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). |
| 6 months |
| baseline, 12 weeks |
| Difference in Mean Scores for Transition Readiness From Baseline to End-of-intervention | Adolescents and Young Adults: Assessed using the STARx, in which higher scores indicate greater readiness for transition and the Parent and Youth Sickle Cell Responsibility Scales. Items on the Sickle Cell Responsibility Scales indicate whether parents or children are taking responsibility for health care treatments and are analyzed in conjunction to determine the level of child treatment responsibility, and agreement between the youth and parent for responsibilities. Each item is scored individually and is worth 1 to 5 points. There are 3 subdomains; subdomain scores are summed for the total score, which ranges from 0 - 90 points. Higher scores = improvement | baseline, 12 weeks |
| Difference in Mean Scores for Anxiety From Baseline to End-of-Intervention | Adolescents: Patient Reported Outcomes Measurement System (PROMIS) Pediatric Short Form Anxiety 8a: Raw Scores range from 0 - 32 with 0 being the lowest anxiety rating and 32 the highest anxiety rating. Change in score at 12 weeks minus baseline. Any decrease difference in mean scores = improved Young adults: Patient Reported Outcomes Measurement System (PROMIS) Short Form Anxiety 8a: Raw Scores range from 8 - 40 with 8 being the lowest anxiety rating and 40 the highest anxiety rating. Change in score at 12 weeks minus baseline. Any decrease difference in mean scores = improved Caregivers: Patient Reported Outcomes Measurement System (PROMIS) Short Form Anxiety 4a: Raw scores range from 4 - 20 with 4 being the lowest anxiety rating and 20 the highest anxiety rating. Change in score at 12 weeks minus baseline. Any decrease difference in mean scores = improved | baseline, 12 weeks |
| Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-Intervention | Adolescents: Patient Reported Outcomes Measurement System (PROMIS) Pediatric short form depression 8a: Raw scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Change in score at 12 weeks minus baseline. Any decrease in differences in mean scores = improved Young Adults: Patient Reported Outcomes Measurement System (PROMIS) short form depression 8a: Raw scores range from 8 - 40, with 8 being the lowest depression rating and 40 the highest depression rating. Change in score at 12 weeks minus baseline. Any decrease in differences in mean scores = improved Caregivers: Patient Reported Outcomes Measurement System (PROMIS) depression 4a: Raw scores range from 4 - 20, with 4 being the lowest depression rating and 20 the highest depression rating. Change in score at 12 weeks minus baseline. Any decrease in differences in mean scores = improved | baseline, 12 weeks |
| Differences in Mean Scores for Pain Intensity From Baseline to End-of-interention | Adolescents: Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity Pediatric 3a. Raw scores range from 3 - 15, with 3 being the lowest pain intensity rating and 15 being the highest pain intensity rating. Change in score at 12 weeks minus baseline. Any decrease in mean difference between scores = improved. Young adults: Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity v2 3a. Raw scores range from 3 - 15, with 3 being the lowest pain intensity rating and 15 being the highest pain intensity rating. Change in score at 12 weeks minus baseline. Any decrease in mean difference between scores = improved. | baseline, 12 weeks |
| Difference in Mean Scores for Fatigue From Baseline to End-of-Intervention | Adolescents: Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Pediatric Short Form 10a: Raw scores range from 0 - 40 with 0 being the least amount of fatigue and 40 the most fatigue. Difference in mean scores at 12 weeks minus baseline. Any decrease in rating = improved Young Adults: Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a: Raw scores range from 8 - 40 with 8 being the least amount of fatigue and 40 the most fatigue. Difference in mean scores at 12 weeks minus baseline. Any decrease in rating = improved Caregivers: Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 4a: Raw scores range from 4 - 20 with 4 being the least amount of fatigue and 20 the most fatigue. Difference in mean scores at 12 weeks minus baseline. Any decrease in rating = improved | baseline, 12 weeks |
| Differences in Mean Scores for Quality of Life From Baseline to End-of-Intervention | Adolescents: Pediatric Quality of Life Inventory (Peds QL): Scores are transformed on a scale from 0 - 100, with 0 indicating the highest possible problems with quality of life and 100 indicating the lowest possible problems with quality of life. Change in score at 12 weeks minus baseline. Any increase in difference between mean scores = improved. Caregivers: Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Physical: Raw scores range from 4 - 20 with 4 being the lowest global physical health and 20 the highest global physical health. Difference in mean scores at 12 weeks minus baseline. Any increase in rating = improved | baseline, 12 weeks |
| Differences in Mean Scores for Condition-Specific Quality of Life From Baseline to End-of-Intervention | Adolescents: Pediatric Quality of Life Inventory (PedsQL) with SCD module: Scores are transformed on a scale from 0 - 100, with 0 indicating the highest possible problems with quality of life and 100 indicating the lowest possible problems with quality of life. Change in score at 12 weeks minus baseline. Any increase in difference in means scores = improved. Young Adults: Adult Sickle Cell Disease Quality of Life Information System (ASCQ-Me): Raw scores for each scale (emotional impact, social impact, sleep impact, stiffness impact, pain impact) range from 5 to 25 with 5 being the lowest health-related quality of life score for each and 25 the highest. Change in score at 12 weeks minus baseline. Any increase in difference in means scores = improved. | baseline, 12 weeks |
| Difference in Mean Scores for Self-Efficacy From Baseline to End-of-Intervention | Adolescents and Young Adults: Sickle Cell Self-Efficacy Scale: Raw scores range from 9 to 45, with 9 being the lowest self-efficacy rating and 45 the highest. Change in score at 12 weeks minus baseline. Any increase in scores = improved | baseline, 12 weeks |
| BG001 | 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). |
| BG002 | 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). |
| BG003 | 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). |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Healthcare providers were not assessed for this baseline measure. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Parent/caregiver type | Healthcare providers, Adolescents, and Young Adults were not assessed for this baseline measure. | Count of Participants | Participants |
|
| Employment status | Count of Participants | Participants |
|
| Education level | Healthcare providers were not assessed for this baseline measure. | Count of Participants | Participants |
|
| Marital status | Healthcare providers were not assessed for this baseline measure. | Count of Participants | Participants |
|
| Household size | Healthcare providers were not assessed for this baseline measure. | Count of Participants | Participants |
|
| Type of licensed provider | Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure. | Count of Participants | Participants |
|
| Primary specialty or subspecialty | Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure. | Count of Participants | Participants |
|
| Years' experience caring for individuals with SCD | Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure. | Count of Participants | Participants |
|
| Number of individual children (<18 years) with SCD seen in the past 12 months | Adolescents, Caregivers, and Young Adults were not assessed for this baseline measure. | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Participant Adherence to the Intervention | Number of participants (adolescent/caregiver dyads and young adults) using the app from baseline to 6 weeks | Healthcare providers did not receive the intervention and are not included in this variable | Posted | Count of Participants | Participants | baseline to 6 weeks |
|
|
|
| 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 | Healthcare providers did not receive the intervention and are not included. | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| 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 | Posted | Count of Participants | Participants | 6 weeks to 12 weeks |
|
|
|
| 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 | Posted | Count of Participants | Participants | 12 weeks to 24 weeks |
|
|
|
| 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). | Healthcare providers: variable not assessed | Posted | Number | young adults recruited and enrolled/week | 6 months |
|
|
|
| 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 | 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 | Posted | Mean | 95% Confidence Interval | scores on scale | baseline, 12 weeks |
|
|
|
| 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 | Caregivers: variable not assessed Healthcare providers: variable not assessed | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 12 weeks |
|
|
|
| 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 | 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 | Posted | Mean | 95% Confidence Interval | scores on scale | baseline, 12 weeks |
|
|
|
| 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 | Healthcare providers: Variable not assessed | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 12 weeks |
|
|
|
| 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. | Caregivers: Variable not assessed Healthcare providers: Variable not assessed | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 12 weeks |
|
|
|
| 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 | Healthcare providers: Variable not assessed | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 12 weeks |
|
|
|
| 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 | Young Adults: Only condition-specific health-related quality of life was assessed and is reported in outcome number 14. Healthcare providers: variable not assessed | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 12 weeks |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 12 weeks |
|
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| 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 | Caregivers: variable not assessed Healthcare providers: variable not assessed | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 12 weeks |
|
|
|
| 30 |
| 5 |
| 30 |
| 1 |
| 30 |
| EG001 | Caregivers | Caregivers of adolescents participating as a dyad | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Young Adults | Young adults ages 18 - 25 receiving intervention | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | Healthcare Providers | Healthcare providers participating in study | 0 | 5 | 0 | 5 | 0 | 5 |
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Not provided
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| missing |
|
| Part-time |
|
| Not employed |
|
| Retired |
|
| missing |
|
| Student |
|
| Some high school |
|
| High school graduate |
|
| Some college |
|
| College graduate |
|
| Post graduate or higher level degree |
|
| missing |
|
| Married |
|
| Widowed |
|
| Separated |
|
| Divorced |
|
| Prefer not to respond |
|
| Missing |
|
| Resides with SO |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| Prefer not to respond |
|
| Missing |
|
| Physician Assistant |
|
| 20 or more years |
|
| More than 300 |
|
| ASCQ-Me Emotional Impact |
|
|
| ASCQ-Me Social Impact |
|
|
| ASCQ-Me Sleep Impact |
|
|
| ASCQ-Me Stiffness Impact |
|
|
| ASCQ-Me Pain Impact |
|
|