Sickle Cell Disease
Conditions
Keywords
Sickle Cell Disease
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).
Interventions
OTHERPeer Community Health Worker
Participants will be communicating with their CHWs on a weekly basis, which is consistent with other successful community health worker protocols with published efficacy. Community Health Workers will be peers with sickle cell disease, who have successfully transitioned and are under 30 years of age.
OTHERMobile Health
A mobile health application created as a resource for young adults transitioning.
Sponsors
St. Christopher's Hospital for Children
Children's Hospital Medical Center, Cincinnati
Steven and Alexandra Cohen Children's Medical Center
Connecticut Children's Medical Center
Patient-Centered Outcomes Research Institute
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health-Related Quality of Life (HRQOL) | Baseline, 6 months, 12months, and 18 months. | Health-Related Quality of life will be assessed with the PedsQL Sickle Cell Disease (SCD) Module. The PedsQL Sickle Cell Disease Module is a well-validated for use in adolescents and young adults with chronic disease and use a Likert response scale, with higher scores indicating better HRQOL and lower SCD symptoms and problems. The PedsQL SCD Module is a 43-item that measures nine scales: Pain and Hurt (9 items), Pain Impact (10 items), Pain Management and Control (2 items), Worry I (5 items), Worry II (2 items), Emotions (2 items), Treatment (7 items), Communication I (3 items), and Communication II (3 items). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transition Readiness | Baseline, 6 months, 12 months, 18 months | Measured using the Transition Readiness Assessment Questionnaire (TRAQ). TRAQ is a 20 item survey of transition readiness. Answer choices are based on stages of change and are on a 5-point scale. |
| Social Support | Baseline, 6 months, 12 months, 18 months | Measured using the Medical Outcomes Study Social Support Survey (MOS-SSS). The MOS-SSS is a 19-item survey. Answer choices are on a 5-point Likert scale ranging from none of the time to all of the time. |
| Coping skills | Baseline, 6 months, 12 months, 18 months | Coping strategies using the Coping Strategies Questionnaire (Brief COPE). The Brief COPE is a 28-item survey with answer choices on a 4-point Likert scale, ranging from I haven't been doing this at all to I've been doing this a lot. |
| Sickle cell disease knowledge | Baseline, 6months, 12 months, 18 months | Measured using the Sickle Cell Disease Knowledge Questionnaire (SCDKQ). SCDKQ is a 20-item survey. All questions have answer choices of true or false. |
| Quality of care received | Baseline, 6 months, 12 months, 18 months | Using the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) measure. The quality of care received subscale is from the ASCQ-Me. The subscale is 27 multiple choice questions. |
| Medical Adherence Scale | Baseline, 6 months, 12 months, 18 months | Medication adherence will be measured using the Medical Adherence Measure (MAM). The MAM is a 17 question multiple choice survey. |
| Education and vocational planning | Baseline, 6 months, 12 months, 18 months | Using the Transition Intervention Program - Readiness for Transition (TIPS-RFT) sub scale to measure education and vocational planning. The educational and vocational planning subscale of the TIPS-RFT is a 4 question subscale. |
Countries
United States
Outcome results
None listed