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Self-Management for Youth and Families Living With SCD - SMYLS

NCT ID: NCT03585543

Last Updated: 2020-11-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-16

Study Completion Date

2019-01-31

Brief Summary

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The purpose of this proposal is to integrate family-centered self-management strategies with mobile health (mHealth) technology to improve reach, self-management behaviors, and child and caregiver physical and psychosocial symptoms and quality of life. Specifically, the investigators propose to conduct feasibility testing of SMYLS, which has been adapted based on user feedback in the first phase of this study. First the investigators will work with the Medical University of South Carolina (MUSC) Pediatric Sickle Cell Clinic to identify and recruit families with children with sickle cell disease (SCD) in the community, statewide. Next, the investigators will test the feasibility of the intervention with 30 dyads of children ages 8 - 17 with sickle cell disease and their parent or primary caregiver, (N=60)

Detailed Description

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Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Single group intervention arm

Group Type EXPERIMENTAL

Voice Crisis Alert V2

Intervention Type BEHAVIORAL

Intervention consists of a mHealth app delivered via smartphone

Interventions

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Voice Crisis Alert V2

Intervention consists of a mHealth app delivered via smartphone

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* children ages 8 - 17 years and parent or primary caregiver 18 years or older
* child with sickle cell disease, as reported by clinician at MUSC Pediatric Sickle Cell Clinic

Exclusion Criteria

* Parent/caregiver or child with cognitive disability or delay that precludes ability to participate
* Lack of wi-fi access
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro00062837

Identifier Type: -

Identifier Source: org_study_id