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The objective of this study is to determine the feasibility and acceptability of SCThrive, a an innovative, technology-enhanced, group self-management intervention that uses a mixed in-person and online format and supported by a tailored mHealth tool, iManage. The study will also evaluate the initial efficacy of SCThrive for increasing behavioral activation (BA) in adolescents with Sickle Cell Disease (SCD) ages 13 to 21. The investigators hypothesize that participants in the SCThrive group will show greater BA (primary outcome) at post-treatment than the attention control group, and that participants in the SCThrive group will continue to show significantly greater BA at the six week follow-up compared to the attention control group. Investigators will also explore whether SCThrive is associated with greater improvements in self-management behaviors and quality of life (secondary outcome) compared to attention control at the six-week follow-up assessment.
The objective of this study is to determine the feasibility and acceptability of SCThrive, a an innovative, technology-enhanced, group self-management intervention that uses a mixed in-person and online format and supported by a tailored mHealth tool, iManage. The study will also evaluate the initial efficacy of SCThrive for increasing behavioral activation (BA) in adolescents with Sickle Cell Disease (SCD) ages 13 to 21.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCThrive | Other | SCThrive Intervention for Adolescents with SCD - 6 week self-management group |
|
| Attention Control | No Intervention | 6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCThrive Intervention for Adolescents with SCD | Behavioral | Chronic Disease Self-Management Program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment) | Participants complete the Patient Activation Measure (PAM-13), which is a 13 item measure on skills, knowledge, confidence and readiness for self-management developed by Hibbard et al., 2005. Items are rated on a 4-point Likert scale of 1 = "Disagree Strongly" to 3 = "Strongly Agree." Raw scores range from 13 to 52 and are converted to scores that range from 0 to 100. This score was then divided into four levels of activation, which reflect a developmental progression from being passive with regard to one's health to being proactive: Level 1 (score of 0.0 - 47.0), Level 2 (47.1 - 55.1), Level 3 (55.2 - 72.4), and Level 4 (72.5 - 100). Higher scores indicate more behavioral activation. | baseline, 6 weeks (post-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment) | Participants complete the Transition Readiness Assessment Questionnaire (TRAQ-5), which is a well-validated 20-item questionnaire that measures the skills needed to manage a chronic condition independently. Items are rated on a 5-point Likert scale of 1 = "No, I do not know how" to 5 = "Yes, I always do this when I need to" and divided into 5 subscales: Managing Medication, Appointment Keeping, Tracking Health Issues, Talking with Providers, and Managing Daily Activities. Overall and subscale scores are calculated by averaging the scores of answered items. Mean scores range from 1 to 5 with higher scores indicating better self-management. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lori E Crosby, PsyD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19636266 | Background | Crosby LE, Modi AC, Lemanek KL, Guilfoyle SM, Kalinyak KA, Mitchell MJ. Perceived barriers to clinic appointments for adolescents with sickle cell disease. J Pediatr Hematol Oncol. 2009 Aug;31(8):571-6. doi: 10.1097/MPH.0b013e3181acd889. | |
| 26275975 | Background | Crosby LE, Joffe NE, Reynolds N, Peugh JL, Manegold E, Pai AL. Psychometric Properties of the Psychosocial Assessment Tool-General in Adolescents and Young Adults With Sickle Cell Disease. J Pediatr Psychol. 2016 May;41(4):397-405. doi: 10.1093/jpepsy/jsv073. Epub 2015 Aug 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SCThrive | SCThrive Intervention for Adolescents with SCD - 6 week self-management group SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program |
| FG001 | Attention Control | 6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SCThrive | SCThrive Intervention for Adolescents with SCD - 6 week self-management group SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program |
| BG001 | Attention Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One participant in SC Thrive did not complete the intervention due to a cognitive issue (n=1). Four participants in Attention Control did not complete the intervention and were lost to follow-up (n=4). |
| 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 | Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment) | Participants complete the Patient Activation Measure (PAM-13), which is a 13 item measure on skills, knowledge, confidence and readiness for self-management developed by Hibbard et al., 2005. Items are rated on a 4-point Likert scale of 1 = "Disagree Strongly" to 3 = "Strongly Agree." Raw scores range from 13 to 52 and are converted to scores that range from 0 to 100. This score was then divided into four levels of activation, which reflect a developmental progression from being passive with regard to one's health to being proactive: Level 1 (score of 0.0 - 47.0), Level 2 (47.1 - 55.1), Level 3 (55.2 - 72.4), and Level 4 (72.5 - 100). Higher scores indicate more behavioral activation. | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 weeks (post-treatment) |
|
baseline, 6 weeks (post-treatment)
Monthly meetings to monitor the progress of the study, the integrity of the treatment and safety monitoring, including a review of any adverse events. If adverse events, investigators followed-up and provided referral or treatment until the event subsided. Investigators were available 24 hours via pager. The PI reported any significant study-related or unanticipated adverse events to the Institutional Review Board and study sponsor based upon institutional and sponsor guidelines.
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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 | SCThrive | SCThrive Intervention for Adolescents with SCD - 6 week self-management group SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lori Crosby | Cincinnati Children's Hospital Medical Center | 513-636-5380 | Lori.Crosby@cchmc.org |
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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 | Mar 19, 2017 | Nov 30, 2020 | Prot_SAP_000.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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| baseline, 6 weeks (post-treatment) |
| Total Scores on the UNC TRxANSITION Scale at Baseline and 6 Weeks Post-Treatment | Participants complete the UNC TRxANSITION Scale, an interview administered by trained independent evaluators to measure the skills of youth with chronic conditions. For this study, we administered 6 of the 10 possible subscales: Type of Chronic Health Condition, Medications, Adherence, Nutrition, Self-Management Skills, and New Health Care Providers. Each item is scored individually as either 1 (adequate knowledge/skill mastery), 0.5 (some knowledge/skill attainment), or 0 (no knowledge/skill attainment). Higher scores indicate better self-management. Subscale scores are calculated by dividing the patient's score by the total possible subscale score. Subscale scores are then combined to create a total score, ranging from 0 to 10, but since we only used 6 scales, 0 to 6. Total and subscale proportion scores were used in analyses. | baseline, 6 weeks (post-treatment) |
| 25414599 | Background | Crosby LE, Joffe NE, Dunseath LA, Lee R. Design Joins the Battle Against Sickle-cell Disease. Des Manage Rev. 2013 Summer;24(2):48-53. doi: 10.1111/drev.10241. No abstract available. |
| 32697889 | Result | Crosby LE, Hood A, Kidwell K, Nwankwo C, Peugh J, Strong H, Quinn C, Britto MT. Improving self-management in adolescents with sickle cell disease. Pediatr Blood Cancer. 2020 Oct;67(10):e28492. doi: 10.1002/pbc.28492. Epub 2020 Jul 22. |
6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | One participant in SC Thrive did not complete the intervention due to a cognitive issue (n=1). Four participants in Attention Control did not complete the intervention and were lost to follow-up (n=4). | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | One participant in SC Thrive did not complete the intervention due to a cognitive issue (n=1). Four participants in Attention Control did not complete the intervention and were lost to follow-up (n=4). | Count of Participants | Participants |
|
| Race (NIH/OMB) | One participant in SC Thrive did not complete the intervention due to a cognitive issue (n=1). Four participants in Attention Control did not complete the intervention and were lost to follow-up (n=4). | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Attention Control | 6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm. |
|
|
|
| Secondary | Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment) | Participants complete the Transition Readiness Assessment Questionnaire (TRAQ-5), which is a well-validated 20-item questionnaire that measures the skills needed to manage a chronic condition independently. Items are rated on a 5-point Likert scale of 1 = "No, I do not know how" to 5 = "Yes, I always do this when I need to" and divided into 5 subscales: Managing Medication, Appointment Keeping, Tracking Health Issues, Talking with Providers, and Managing Daily Activities. Overall and subscale scores are calculated by averaging the scores of answered items. Mean scores range from 1 to 5 with higher scores indicating better self-management. | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 weeks (post-treatment) |
|
|
|
|
| Secondary | Total Scores on the UNC TRxANSITION Scale at Baseline and 6 Weeks Post-Treatment | Participants complete the UNC TRxANSITION Scale, an interview administered by trained independent evaluators to measure the skills of youth with chronic conditions. For this study, we administered 6 of the 10 possible subscales: Type of Chronic Health Condition, Medications, Adherence, Nutrition, Self-Management Skills, and New Health Care Providers. Each item is scored individually as either 1 (adequate knowledge/skill mastery), 0.5 (some knowledge/skill attainment), or 0 (no knowledge/skill attainment). Higher scores indicate better self-management. Subscale scores are calculated by dividing the patient's score by the total possible subscale score. Subscale scores are then combined to create a total score, ranging from 0 to 10, but since we only used 6 scales, 0 to 6. Total and subscale proportion scores were used in analyses. | Data assessing transition readiness (UNC TRxANSITION Scale) were only collected from adolescents and and young adults completing SCThrive (N=16). | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 weeks (post-treatment) |
|
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Attention Control | 6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm. | 0 | 27 | 0 | 27 | 0 | 27 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|