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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

Study 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.Check my eligibility

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.See study design

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 below

Select...

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

Secondary outcome measures

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)

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,722 Previous Clinical Trials

16,342,786 Total Patients Enrolled

Department of Health and Human ServicesFED

226 Previous Clinical Trials

928,789 Total Patients Enrolled

Andi Saptono, Ph.D.Principal Investigator - University of Pittsburgh

University of Pittsburgh

Frequently Asked Questions

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

How many people have enrolled in the research project thus far?

"Indeed, clinicaltrials.gov stipulates that this study is actively recruiting patients. Having been first posted on October 1st 2015 and last updated at September 6th 2022, the trial requires 160 participants from a single centre."

Answered by AI

Are there any vacancies for participants in this medical trial?

"Yes, the clinicaltrials.gov website indicates that this study is actively recruiting volunteers; it was initially posted on October 1st 2015 and has been recently updated on September 6th 2022. 160 participants must be recruited from a single site for successful completion of the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions

Andi Saptono 2015. "Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02592291.

All > Spina Bifida > Cerebral Palsy