Clinical trial NCT03648710: Community Health Workers and mHealth for Sickle Cell Disease Care
Official title: Community Health Workers and Mobile Health for Emerging Adults Transitioning Sickle Cell Disease Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Disease
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: St. Christopher's Hospital for Children
name: Children's Hospital Medical Center, Cincinnati
name: Steven and Alexandra Cohen Children's Medical Center
name: Connecticut Children's Medical Center
name: Patient-Centered Outcomes Research Institute
First posted: 2018-08-27
Enrollment: 405
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Health-Related Quality of Life (HRQOL)
timeFrame: Baseline, 6 months, 12months, and 18 months.
Secondary outcomes:
measure: Sickle cell disease knowledge
timeFrame: Baseline, 6months, 12 months, 18 months
measure: Transition Readiness
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Social Support
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Coping skills
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Education and vocational planning
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Quality of care received
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Medical Adherence Scale
timeFrame: Baseline, 6 months, 12 months, 18 months
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: New Hyde Park
country: United States
facility: Cohen's Children's Medical Center
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: St. Christophers Hospital for Children
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: David Rubin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cohen's Children Medical Center/Northwell Health
name: Sophia Jan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Kim Smith-Whitley, MD
role: PRINCIPAL_INVESTIGATOR
References: