- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03716726
Sickle Cell Anemia WE CARE (SCAWECARE)
Understanding and Addressing the Social Determinants of Health for Families of Children With Sickle Cell Anemia Within Pediatric Hematology
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult parents of children with SCA (0-12 years of age) who take a daily medication (penicillin or hydroxyurea)to
- English or Spanish speaking
Exclusion Criteria:
- Foster parents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control-Standard of Care
Standard of care for pediatric patients with sickle cell anemia will be delivered.
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Usual outpatient care for pediatric patients with sickle cell anemia will be provided.
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Experimental: Intervention-WE CARE
The WE CARE SDoH Screening Survey will be given at all visits by the front desk staff to all parents of Sickle Cell Anemia patients who present to the pediatric hematology clinic. They will also be provided the Family Resource Book. Clinical team members (i.e. medical assistants and providers) will be trained to review the WE CARE Social Determinants of Health survey at visits and to provide community resource information sheets to parents with needs. The completed surveys will be scanned into the electronic health record (EHR). |
The survey will be given at all visits by the front desk staff to all parents of SCA patients.
It consists of 12 questions designed to: (1) briefly identify 6 unmet material needs (e.g., childcare, employment, food security, household heat, housing inadequate education) by self-report and (2) using a family-centered approach, determine whether parents would like assistance with each problem Parents wanting help will receive a resource referral.
Clinical team members will be trained to review the WE CARE SDoH survey at visits and to provide community resource information sheets to parents with needs.
Completed surveys will be scanned into the EHR
The Family Resource book will contain one-page information sheets listing community resources (e.g., food pantries) and their contact information (i.e.
telephone number) for each specific material need (e.g., food insecurity).
Information sheets will be specific to each site and written at, or below, the 8th grade level.
For parents with an identified need, providers will be instructed to give an information sheet.
The book will contain six separate tabs, one for each unmet need, and will contain multiple copies of the information sheets.
The Family Resource Book will be made available in each exam room.
The investigators will work with each practice to create a Family Resource Book prior to study initiation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Emergency Department (ED)/Acute Care Visits
Time Frame: 12 months
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Data on number of ED visits and acute care visits abstracted from the EHR.
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12 months
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Parental Enrollment in Community Resources
Time Frame: 12 months
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Self-reported enrollment in a new community resource, where "yes" indicates enrollment in a new resource, and "no" indicates no enrollment in a new resource.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Personal Health Questionnaire Depression Scale (PHQ-8)
Time Frame: 12 months
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Patient Health Questionnaire depression scale (PHQ-8) is an 8 item instrument with possible responses for each item of 0=Not at all, 1=Several days 2= More than half the days, 3=Nearly every day.
The range of scores is 0 to 24.
A score of 10 or greater is considered major depression, 20 or more is severe major depression.
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12 months
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Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months
Time Frame: 12 months
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Self-reported measure of effective and ineffective ways to cope with a stressful life event.
28 total items (list of coping behaviors) scored on a 4-point Likert scale from 1 (I haven't been doing this at all) to 4 (I've been doing this a lot).
There are 14 coping behaviors for the 28 items and scores for each of the 14 can range from 1-8.
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12 months
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Vaso-occlusive Episodes
Time Frame: 12 months
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Number of painful vaso-occlusive episodes (VOE) requiring an ED or acute care clinic visit
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12 months
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Prescriptions for Sickle Cell Disease
Time Frame: 12 months
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Data on prescriptions written and filled for hydroxyurea and penicillin will be collected through EHR review. .
Number of days covered by prescriptions will be reported
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12 months
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Hemoglobin Values Related to Medication Adherence
Time Frame: 12 months
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Laboratory markers commonly affected by hydroxyurea medication from the CBC (complete blood count) include hemoglobin and hemoglobin F levels, white blood cell and absolute neutrophil counts, and mean corpuscular volume.
Each wil be abstracted from the medical records.
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12 months
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White Blood Cell and Absolute Neutrophil Counts Related to Medication Adherence
Time Frame: 12 months
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Laboratory markers commonly affected by hydroxyurea medication from the CBC (complete blood count) including hemoglobin and hemoglobin F levels, white blood cell and absolute neutrophil counts, and mean corpuscular volume.
Each will be abstracted from medical records.
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12 months
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Mean Corpuscular Volume Values Related to Medication Adherence
Time Frame: 12 months
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Laboratory markers commonly affected by hydroxyurea medication from the CBC (complete blood count) including hemoglobin and hemoglobin F levels, white blood cell and absolute neutrophil counts, and mean corpuscular volume (MCV) will be abstracted from medical records.
MCV is a measure of the average volume of a red blood corpuscle (or red blood cell).
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Arvin Garg, MD MPH, University of Massachusetts Medical School, Worcester
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-38214
- 1R01HL141774-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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