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Standard of care for Sickle Cell Disease (SCAWECARE Trial)

N/A
Waitlist Available
Led By Arvin Garg, MD MPH
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

SCAWECARE Trial Summary

This trial will test a previously successful intervention for screening and referral for social determinants of health in a pediatric hematology outpatient setting. They will also qualitatively assess how the intervention affects child health, and use that information to plan a larger clinical trial.

Eligible Conditions
  • Sickle Cell Disease

SCAWECARE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Emergency Department (ED)/Acute Care Visits
Parental Enrollment in Community Resources
Secondary outcome measures
Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months
Hemoglobin Values Related to Medication Adherence
Mean Corpuscular Volume Values Related to Medication Adherence
+4 more

Side effects data

From 2007 Phase 4 trial • 552 Patients • NCT00110890
7%
Diarrhoea
7%
Vomiting
3%
Nausea
3%
Nasopharyngitis
3%
Muscle spasms
1%
Shunt thrombosis
1%
Pancreatic carcinoma
1%
Angina pectoris
1%
Myocardial infarction
1%
Pericarditis
1%
Jaundice
1%
Shunt occlusion
1%
Gastroenteritis
1%
Hernia
1%
Chest discomfort
1%
Arteriovenous fistula thrombosis
1%
Skin ulcer
1%
Fluid retention
1%
Hypovolaemia
1%
Hypertensive crisis
1%
Cognitive disorder
1%
Joint dislocation
1%
Joint injury
1%
Blood potassium increased
1%
Catheter placement
1%
Arteriovenous fistula occlusion
1%
Orthostatic hypotension
1%
Cardiac arrest
1%
Chest pain
1%
Pyrexia
1%
Cholecystitis
1%
Arthritis bacterial
1%
Bacterial sepsis
1%
Fall
1%
Back pain
1%
Pain in extremity
1%
Dyspnoea
1%
Nephrectomy
1%
Hypotension
1%
Peripheral ischaemia
1%
Atrial flutter
1%
Cardiac asthma
1%
Abdominal pain
1%
Sudden cardiac death
1%
Transplant rejection
1%
Perianal abscess
1%
Pneumonia
1%
Urinary tract infection
1%
Ankle fracture
1%
Arteriovenous fistula site complication
1%
Rib fracture
1%
Cerebral infarction
1%
Gastrointestinal haemorrhage
1%
Catheter related infection
1%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Care
Cinacalcet

SCAWECARE Trial Design

2Treatment groups
Experimental Treatment
Group I: Intervention-WE CAREExperimental Treatment2 Interventions
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).
Group II: Control-Standard of CareExperimental Treatment1 Intervention
Standard of care for pediatric patients with sickle cell anemia will be delivered.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
WE CARE SDoH Screening Survey
2021
N/A
~120
Family Resource Book
2021
N/A
~120

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor
382 Previous Clinical Trials
869,287 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,384 Total Patients Enrolled
Arvin Garg, MD MPHPrincipal InvestigatorUniversity of Massachusetts Medical School, Worcester
1 Previous Clinical Trials
1,205 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies left for participants in this trial?

"The data hosted on clinicaltrials.gov reveals that the recruitment period for this trial has ended; it was first posted on January 21st 2021 and most recently updated on September 20th 2022. Nonetheless, there are still 198 other clinical trials seeking patients at present."

Answered by AI

What is the purpose of this experiment?

"This clinical trial's primary outcome, which will be evaluated throughout a Baseline and 3, 6, 9, and 12 month timeline is the rate of Emergency Department Rely (EDR). Secondary outcomes encompass Vaso-occlusive episodes data collected from electronic health records (EHRs), changes in Personal Health Questionnaire Depression Scale scores determined by self-reported 4-point Likert scales with higher numbers indicating more severity, as well as baseline PedsQL + Sickle cell Disease Module assessments composed of 42 items graded on 5-point Likert systems where higher values suggest fewer issues."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Sickle Cell Anemia WE CARE
2021. "Sickle Cell Anemia WE CARE". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03716726.
~26 spots leftby Apr 2025
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