Improving Self-Management in Adolescents With Sickle Cell Disease (SCThrive)
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|ClinicalTrials.gov Identifier: NCT02851615|
Recruitment Status : Completed
First Posted : August 1, 2016
Results First Posted : March 17, 2021
Last Update Posted : March 17, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease||Behavioral: SCThrive Intervention for Adolescents with SCD||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||SCThrive: Improving Self-Management in Adolescents With Sickle Cell Disease|
|Actual Study Start Date :||March 31, 2016|
|Actual Primary Completion Date :||March 31, 2018|
|Actual Study Completion Date :||March 31, 2018|
SCThrive Intervention for Adolescents with SCD - 6 week self-management group
Behavioral: SCThrive Intervention for Adolescents with SCD
Chronic Disease Self-Management Program
No Intervention: Attention Control
6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
- Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment) [ Time Frame: baseline, 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.
- Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment) [ Time Frame: baseline, 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.
- Total Scores on the UNC TRxANSITION Scale at Baseline and 6 Weeks Post-Treatment [ Time Frame: baseline, 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.
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|Ages Eligible for Study:||13 Years to 21 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patient of CCHMC Sickle Cell Clinic.
- Confirmed diagnosis of SCD with SS, SB0Thal or SC genotype.
- 13-21 years of age.
- On or eligible for disease-modifying therapies.
- Caregiver (or AYA > 18 years) consent that the participant will be the sole user of the tablet, report immediately if it is damaged or lost, return it at the end of the study, and log on to sessions from a private location.
- another chronic disease (which would complicate measurement of behavioral activation)
- Non-English-speaking (<5% of the target population); or
- cognitive or psychiatric disorder that the physician or study therapists believe would impair study participation. Patients who desire participation but are not eligible will be referred to the SCD Clinic social worker for assistance with self-management as this is the usual procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02851615
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Lori E Crosby, PsyD||Children's Hospital Medical Center, Cincinnati|
Documents provided by Children's Hospital Medical Center, Cincinnati:
|Responsible Party:||Children's Hospital Medical Center, Cincinnati|
|Other Study ID Numbers:||
1R21HD084810-01A1 ( U.S. NIH Grant/Contract )
|First Posted:||August 1, 2016 Key Record Dates|
|Results First Posted:||March 17, 2021|
|Last Update Posted:||March 17, 2021|
|Last Verified:||March 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Anemia, Sickle Cell
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn