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Community Health Worker Support + mHealth for Sickle Cell Disease
N/A
Waitlist Available
Led By Kim Smith-Whitley, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have sickle cell disease, defined as those individuals with HbSS, HbSC, HbSβ0Thal, HbSβ+Thal genotypes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6months, 12 months, 18 months
Awards & highlights
Study Summary
This trial will compare two ways of helping people with sickle cell disease manage their health, through community health workers and mobile technology, to see which is more effective.
Who is the study for?
This trial is for males and females aged 17 or older with sickle cell disease (specifically HbSS, HbSC, HbSβ0Thal, or HbSβ+Thal genotypes) who are patients at a participating pediatric center and will transfer to an adult hematologist within a year. It's not for those with severe intellectual disabilities that prevent interaction with mobile/web programs or community health workers.Check my eligibility
What is being tested?
The study compares two self-management support methods: assistance from Community Health Workers (CHW) and using mobile health technology (mHealth), against the standard care practices. The goal is to see which improves life quality and reduces emergency care needs in young adults transitioning out of pediatric sickle cell disease care.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like support from health workers and use of mobile health apps, traditional side effects associated with medications are not applicable. However, participants may experience issues related to the usability of technology or personal interactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have sickle cell disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6months, 12 months, 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6months, 12 months, 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Health-Related Quality of Life (HRQOL)
Secondary outcome measures
Coping skills
Education and vocational planning
Medical Adherence Scale
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Peer Community Health WorkerExperimental Treatment1 Intervention
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
Group II: Mobile HealthExperimental Treatment1 Intervention
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.
Group III: Enhanced Usual CareActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Steven and Alexandra Cohen Children's Medical Center of Northwell HealthUNKNOWN
Patient-Centered Outcomes Research InstituteOTHER
549 Previous Clinical Trials
29,996,143 Total Patients Enrolled
Children's Hospital Medical Center, CincinnatiOTHER
815 Previous Clinical Trials
6,531,191 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 17 years old or older.I cannot use or interact with digital programs or have conversations, even with help.I am ready to be transferred to an adult blood specialist within a year.I have sickle cell disease.
Research Study Groups:
This trial has the following groups:- Group 1: Mobile Health
- Group 2: Enhanced Usual Care
- Group 3: Peer Community Health Worker
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it still possible to take part in this clinical experiment?
"A review of clinicaltrials.gov reveals that the trial, which was initially made available on January 15th 2019, is still actively searching for participants. The listings were last modified on July 14th 2022."
Answered by AI
How many healthcare facilities are participating in this trial?
"Currently, 5 locations are hosting this clinical trial; these include St. Christophers Hospital for Children in Philadelphia, Cohen's Children's Medical Center in New Hyde Park, and Connecticut Children's Medical Center in Hartford. Additionally, there are another five sites across the nation facilitating this study."
Answered by AI
How many individuals are actively engaged in this clinical experiment?
"A total of 450 eligible patients must be enrolled in this medical trial. Individuals can register to participate at St. Christopher's Hospital for Children in Philadelphia, Pennsylvania or Cohen’s Children’s Medical Center in New Hyde Park, New york."
Answered by AI
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