Improving Self-Management in Adolescents With Sickle Cell Disease

NCT02851615 | Completed Results

• 1 other identifier: 1R21HD084810-01A1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

Anemia, Sickle Cell; Self Care; Adolescent; Young Adult; Disease Management; Behavioral Activation; Peer Communication

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment)

  baseline, 6 weeks (post-treatment)

• Total Scores on the UNC TRxANSITION Scale at Baseline and 6 Weeks Post-Treatment

  baseline, 6 weeks (post-treatment)

Study Arms (2)

SCThrive

OTHER

SCThrive Intervention for Adolescents with SCD - 6 week self-management group

Behavioral: SCThrive Intervention for Adolescents with SCD

Attention Control

NO INTERVENTION

6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.

Interventions

SCThrive Intervention for Adolescents with SCD BEHAVIORAL

Chronic Disease Self-Management Program

SCThrive

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient of CCHMC Sickle Cell Clinic.
• Confirmed diagnosis of SCD with SS, SB0Thal or SC genotype.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (4)

• 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.

  PMID: 19636266 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.

  PMID: 26275975 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.

  PMID: 25414599 BACKGROUND

• 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.

  PMID: 32697889 RESULT

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Lori Crosby
• Organization: Cincinnati Children's Hospital Medical Center

Lori.Crosby@cchmc.org

513-636-5380

Study Officials

• Lori E Crosby, PsyD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 1, 2016
• Study Start: March 31, 2016
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: March 4, 2024
• Results First Posted: March 17, 2021

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)