Community Health Workers and mHealth for Sickle Cell Disease Care

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Sickle Cell Disease

Treatments: Other: Mobile Health; Other: Peer Community Health Worker

Study type: Interventional

Funder types: Other

Identifiers

NCT03648710

18-015106

Details and patient eligibility

About

This study will compare the effectiveness of two self-management support interventions-Community Health Workers (CHW) and mobile health (mHealth)-versus enhanced usual care to improve health-related quality of life and acute care use for transitioning youth with sickle cell disease (SCD), and identify and quantify mediators and moderators of intervention treatment effects.

Full description

Emerging adults with sickle cell disease (SCD) experience a seven-fold increase in mortality rates during the transition period (16-25 years of age). This staggering increase in mortality and acute care utilization during this vulnerable period is partly due to difficulty coordinating care during the transition to adult care. Critical psychosocial issues further compound the vulnerability of emerging adults with SCD during the transition from pediatric to adult care9. Unfortunately, none of these transition intervention studies included adolescents or young adults with SCD. Patients, parents, and providers of those with SCD agree that the ability to independently perform chronic disease self-management is critical to staying healthy during this turbulent transition period.

Self-management support is a key component of the Chronic Care Model. Community health worker (CHW) programs are increasingly popular and have efficacy on chronic disease self-management and system navigation. Mobile health platforms are equally popular, and have efficacy on self-management and adherence. Unfortunately, the effectiveness of mHealth and tailored texting among emerging adults with SCD is still unknown. Furthermore, also unknown is the comparative effectiveness of CHW programs and mHealth.

The purpose of the study is to determine the comparative effectiveness of CHW programs and mHealth among emerging adults with SCD during transition versus enhanced usual care to improve health-related quality of life and acute care use for transitioning youth with SCD.

The primary objective of this study is to compare the effectiveness of two self-management support interventions (community health workers and mobile health) versus enhanced usual care to improve health-related quality of life and acute care use for transitioning youth with SCD. The secondary objectives are to:

• Identify and quantify whether patient activation, self-management behaviors, biologic markers, and transfer to adult care are mediators of intervention treatment effects.
• Identify individual and family factors that moderate intervention treatment effects

The exploratory aim is to:

•Explore the association of enhancements to usual care on pediatric and adult acute utilization

The study population will consist of all patients with SCD who are 17 or older and are appropriate for transfer to an adult hematologist within 12 months. Excluded are 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).

Enrollment: 405 patients

Sex: All

Ages: 17+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males or females age 17 years or older
• Have sickle cell disease, defined as those individuals with HbSS, HbSC, HbSβ0Thal, HbSβ+Thal genotypes
• Receive care at a participating pediatric sickle cell disease center.
• Appropriate for transfer to an adult hematologist within 12 months

Exclusion criteria

• 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). Individuals without access to a mobile device, tablet or computer.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

405 participants in 3 patient groups

Enhanced Usual Care

No Intervention group

Description:

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.

Peer Community Health Worker

Experimental group

Description:

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

Treatment:

Other: Peer Community Health Worker

Mobile Health

Experimental group

Description:

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.

Treatment:

Other: Mobile Health