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Mobile Technology for Pain Management
N/A
Recruiting
Led By Nirmish Shah
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Currently admitted to the hospital
Any patient 8-80 years old with a past medical history for a chronic disease (such as sickle cell disease), cancer (solid tumor, lymphoma, brain tumor), or currently undergoing bone marrow transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
Study Summary
This trial is testing whether mobile technology can help manage pain in patients with chronic diseases.
Who is the study for?
The TRU-PAIN trial is for hospitalized patients aged 8-80 with chronic diseases like sickle cell, cancer, or those undergoing bone marrow transplant and experiencing pain. It's not for ICU patients or those who can't use a mobile device independently.Check my eligibility
What is being tested?
This study tests if using a SMART app wearable to monitor heart rate, sleep, and movement helps manage pain better than standard care. Patients will be randomly assigned to either the technology-enhanced monitoring or regular treatment after initial feedback.See study design
What are the potential side effects?
Since this trial involves non-invasive mobile technology rather than medication, traditional side effects are not expected. However, there may be discomfort from wearing the device or privacy concerns related to data collection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently in the hospital.
Select...
I am between 8 and 80 years old with a chronic disease, cancer, or am undergoing a bone marrow transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
P-Chloroamphetamine
Secondary outcome measures
magnitude of change in pain scores
patient/family satisfaction scores as measured by feasibility survey
time of movement during hospitalization
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SMART app wearable deviceExperimental Treatment1 Intervention
Patients will be given a wearable such as a Microsoft Band accelerometer to track movement, heart rate, galvanic skin response and sleep, which will be collected in combination with the data from the SMART visual dashboard. Data will be sent to the SMART dashboard as well as stored on the iPad/iPod touch via software from the manufacturer. Participants having a "wearable device" will receive the education intervention (such as haptic prompted texts that state 'try and walk today', 'have you had enough water today', 'make sure to take deep breaths').
Group II: Standard of CareActive Control1 Intervention
Patients will continue with their normal Standard of Care for their condition
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,360 Previous Clinical Trials
3,420,230 Total Patients Enrolled
25 Trials studying Pain
8,741 Patients Enrolled for Pain
Nirmish ShahPrincipal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently in the hospital.I am at least 8 years old.I am between 8 and 80 years old with a chronic disease, cancer, or am undergoing a bone marrow transplant.I am currently being treated for pain related to my condition.I signed up for the trial within 2 days of being admitted.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: SMART app wearable device
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.
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