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NCT02851615: SCThrive

Improving Self-Management in Adolescents With Sickle Cell Disease

Completed NA Results posted Last updated 4 March 2024
What this trial tests

NA trial testing SCThrive Intervention for Adolescents with SCD in Sickle Cell Disease in 66 participants. Completed in 31 March 2018.

Timeline
31 March 2016
Primary endpoint
31 March 2018
31 March 2018

Quick facts

Lead sponsorChildren's Hospital Medical Center, Cincinnati
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment66
Start date31 March 2016
Primary completion31 March 2018
Estimated completion31 March 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

Adults 13 to 21, any sex, with Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment) Primary · 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

Baseline Scores
GroupValue95% CI
SCThrive68.48± 15.47
Attention Control69.13± 20.75
Post- Treatment Scores
GroupValue95% CI
SCThrive76.57± 15.04
Attention Control68.82± 18.18
Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment) Secondary · 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 hi

Baseline Scores
GroupValue95% CI
SCThrive3.46± .83
Attention Control3.54± .81
Post-Treatment Scores
GroupValue95% CI
SCThrive3.68± .81
Attention Control3.53± .79
Total Scores on the UNC TRxANSITION Scale at Baseline and 6 Weeks Post-Treatment Secondary · 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

Baseline Score
GroupValue95% CI
SCThrive1.19± .13
Post-Treatment Score
GroupValue95% CI
SCThrive1.15± .11

Sponsor's own 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. 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Mobile health use predicts self-efficacy and self-management in adolescents with sickle cell disease.
    Hood AM, Nwankwo C, Walton A, McTate E, et al · · 2021 · cited 18× · PMID 33949674 · DOI 10.1093/tbm/ibab041
  2. Allocation of Treatment Responsibility and Adherence to Hydroxyurea Among Adolescents With Sickle Cell Disease.
    Creary SE, Modi AC, Stanek JR, Chisolm DJ, et al · · 2019 · cited 8× · PMID 31403687 · DOI 10.1093/jpepsy/jsz061

Verify or expand the search:

Other recruiting trials for Sickle Cell Disease

Currently open trials in the same condition.

Other Children's Hospital Medical Center, Cincinnati trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02851615.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing