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MHealth System for Chronic Health Conditions
N/A
Recruiting
Led By Andi Saptono, Ph.D.
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
12 years or older
Have a diagnosis of a chronic and complex condition such as Spina Bifida, Spinal Cord Injury, Cerebral Palsy, and Traumatic Brain Injury, etc.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year.
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the outcomes of people with chronic health conditions who use a mobile health system to those who receive standard care.
Who is the study for?
This trial is for individuals aged 12 or older with chronic conditions like Spinal Cord Injury, Cerebral Palsy, Spina Bifida, or Traumatic Brain Injury. They must be able to use a smartphone and live outside of care facilities. Those with severe intellectual disabilities or persistent psychiatric illnesses cannot participate.
What is being tested?
The study tests a mobile health (mHealth) system designed to help people with complex health conditions manage their wellness better compared to standard care. It aims to improve self-management skills through the use of technology.
What are the potential side effects?
Since this trial involves using a mobile app for health management, there are no direct medical side effects. However, participants may experience frustration or stress if they find the technology challenging.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 12 years old or older.
Select...
I have a chronic condition like Spina Bifida or Cerebral Palsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Medical Outcomes-Improvements in Frequency of Health Care Utilization based on Medical Record Review and Questionnaire.
Medical Outcomes-Improvements in Length of Health Care Utilization based on Medical Record Review
Medical Outcomes-Improvements in Preventable Conditions based on Medical Record Review
+5 moreSecondary study objectives
Change of Participants' experience using the mHealth system over time as assessed by questionnaire
Cost of care
Usage of the system as assessed by questionnaire and record review of the system usage (a built-in function in the system)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MHealth GroupExperimental Treatment1 Intervention
Participants randomized into this group will use the mHealth system throughout the study in conjunction with their standard of care
Group II: ControlActive Control1 Intervention
Participants randomized into this group will not use the mHealth system throughout the study, but will continue with their standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MHealth
2022
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,789 Previous Clinical Trials
16,359,463 Total Patients Enrolled
Department of Health and Human ServicesFED
232 Previous Clinical Trials
935,543 Total Patients Enrolled
Brad E. Dicianno, M.D.Study DirectorUniversity of Pittsburgh
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