Improving Self-Management in Adolescents With Sickle Cell Disease (SCThrive)

• ClinicalTrials.gov Identifier: NCT02851615
• Recruitment Status: Completed
• First Posted: August 1, 2016
• Results First Posted: March 17, 2021
• Last Update Posted: March 17, 2021
• Sponsor: Children's Hospital Medical Center, Cincinnati
• Information provided by (Responsible Party): Children's Hospital Medical Center, Cincinnati

Tracking Information

• First Submitted Date: July 28, 2016
• First Posted Date: August 1, 2016
• Results First Submitted Date: December 18, 2020
• Results First Posted Date: March 17, 2021
• Last Update Posted Date: March 17, 2021
• Actual Study Start Date: March 31, 2016
• Actual Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 12, 2021)

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.

Original Primary Outcome Measures (submitted: July 28, 2016)

Change from baseline on behavioral activation measure at 6 weeks [ Time Frame: baseline, 6 weeks (post-intervention ]

Participants complete a 13 item measure on skills, knowledge, confidence and readiness for self-management developed by Hibbard et al., 2005.

Current Secondary Outcome Measures (submitted: March 12, 2021)

• 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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Improving Self-Management in Adolescents With Sickle Cell Disease
• Official Title: SCThrive: Improving Self-Management in Adolescents With Sickle Cell Disease
• Brief Summary: 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.
• Detailed Description: 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Sickle Cell Disease

Intervention

Behavioral: SCThrive Intervention for Adolescents with SCD

Chronic Disease Self-Management Program

Study Arms

• SCThrive
  SCThrive Intervention for Adolescents with SCD - 6 week self-management group
  Intervention: Behavioral: SCThrive Intervention for Adolescents with SCD
• No Intervention: Attention Control
  6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.

Publications *

• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 12, 2021): 66
• Original Estimated Enrollment (submitted: July 28, 2016): 64
• Actual Study Completion Date: March 31, 2018
• Actual Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years to 21 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02851615
• Other Study ID Numbers: 1R21HD084810-01A1( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Children's Hospital Medical Center, Cincinnati
• Original Responsible Party: Same as current
• Current Study Sponsor: Children's Hospital Medical Center, Cincinnati
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lori E Crosby, PsyD; Children's Hospital Medical Center, Cincinnati

• PRS Account: Children's Hospital Medical Center, Cincinnati
• Verification Date: March 2021