Improving Self-Management in Adolescents With Sickle Cell Disease

Not Applicable

Completed

Conditions: Sickle Cell Disease

Interventions: Behavioral: SCThrive Intervention for Adolescents with SCD

Registration Number: NCT02851615

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 66

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment)	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.

Secondary Outcome Measures

Name	Time	Method
Total Scores on the UNC TRxANSITION Scale at Baseline and 6 Weeks Post-Treatment	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.
Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment)	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.