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Community Health Worker Support + mHealth for Sickle Cell Disease

N/A

Waitlist Available

Led By Kim Smith-Whitley, MD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have sickle cell disease, defined as those individuals with HbSS, HbSC, HbSβ0Thal, HbSβ+Thal genotypes

Must not have

Individuals with an intellectual disability that is severe enough that the individual would not have the capacity to interact with a mobile or web-based program even with assistance or have a conversation with a community health worker (i.e. non-verbal)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6months, 12 months, 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two ways of helping people with sickle cell disease manage their health, through community health workers and mobile technology, to see which is more effective.

Who is the study for?

This trial is for males and females aged 17 or older with sickle cell disease (specifically HbSS, HbSC, HbSβ0Thal, or HbSβ+Thal genotypes) who are patients at a participating pediatric center and will transfer to an adult hematologist within a year. It's not for those with severe intellectual disabilities that prevent interaction with mobile/web programs or community health workers.

What is being tested?

The study compares two self-management support methods: assistance from Community Health Workers (CHW) and using mobile health technology (mHealth), against the standard care practices. The goal is to see which improves life quality and reduces emergency care needs in young adults transitioning out of pediatric sickle cell disease care.

What are the potential side effects?

Since this trial involves non-medical interventions like support from health workers and use of mobile health apps, traditional side effects associated with medications are not applicable. However, participants may experience issues related to the usability of technology or personal interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have sickle cell disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot use or interact with digital programs or have conversations, even with help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6months, 12 months, 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6months, 12 months, 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6months, 12 months, 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Health-Related Quality of Life (HRQOL)

Secondary study objectives

Coping skills

Education and vocational planning

Medical Adherence Scale

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Peer Community Health WorkerExperimental Treatment1 Intervention

The CHW program will primarily be modeled after the highly successful IMPaCT Program developed by the Penn Center for Community Health Workers and CHOP's Youth CHW Program for Pediatric to Adult Transitions developed by our research team, which were both developed with high levels of patient input. SCD specific content and expertise from the CHW Program through the Sickle Cell Disease Association of American Philadelphia Delaware Valley Chapter and other published models will be included. Components will include: 1) development of patient-centered goals and individualized action plan around self-care, symptom tracking, and transition to adult care; 2) provision of information, skills, and tips; and 3) tailored peer support using telephone calls and/or visits

Group II: Mobile HealthExperimental Treatment1 Intervention

All participants enrolled in the mHealth arm will download an enhanced version of iManage, which was developed by Co-Investigator Lori Crosby at and adolescents and young adult patients with SCD. Components include: 1) development of patient-centered goals around self-care, symptom tracking, and transition to adult care; 2) provision of information, skills, and tips; 3) virtual peer support where users can encourage others to complete goals, forms teams, and interact with other youth with SCD; and 4) daily symptom tracking and visual tracking of goal completion. Investigators will add with daily tailored texting.

Group III: Enhanced Usual CareActive Control1 Intervention

Enhanced usual care will be standardized across sites with transition/transfer of care checklists that will be used at all sites. Enhanced usual care will minimally include (1) patient seen by the pediatric provider with the parent outside the examination room, (2) a social work consult to screen and address sociodemographic risk factors, (3) information on health insurance adequacy provided to patient, (4) adult hematologist identified, (5) adult primary care provider identified, (6) medical release signed, and (7) medical record viewable or sent to adult provider.

0 / 2Eligibility criteria met