Improving Self-Management in Adolescents With Sickle Cell Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SCThrive

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

Group Type OTHER

SCThrive Intervention for Adolescents with SCD

Intervention Type BEHAVIORAL

Chronic Disease Self-Management Program

Attention Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SCThrive Intervention for Adolescents with SCD

Chronic Disease Self-Management Program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No