Use of a Mobile-based App for SCD Patients

Chronic Pain Clinical Trial

— SMART  

Official title:

Use of a Mobile-based Pain Assessment Application for SCD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833702
• Other study ID #: Pro00037857
• Status: Completed
• Start date: June 2012
• Est. completion date: May 2014

Study information

• Verified date: November 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study will seek to enroll 100 sickle cell or thalassemia patients who are age 12 or older who have access to a smartphone or tablet with Internet access daily.

The study will evaluate patient-reported comfort level with using a mobile device to record their pain levels, as well as adherence to recording these levels daily.

The study will track patients' assessment of their pain, actions taken, and outcomes related to pain management and provider involvement.

This study will attempt to collect information about differences in the use of two traditional pain assessment modes (verbal scale and paper) versus the use of a pain assessment tool on a mobile device in the form of a smartphone, tablet, or iPad with an Android or iOS operating system.

Description:

The study will evaluate patient-reported comfort level with using a mobile device to record their pain levels, as well as adherence to recording these levels daily. The study will track patients' assessment of their pain, actions taken, and outcomes related to pain management and provider involvement. This study will attempt to collect information about differences in the use of two traditional pain assessment modes (verbal scale and paper) versus the use of a pain assessment tool on a mobile device in the form of a smartphone, tablet, or iPad with an Android or iOS operating system. The study will seek to enroll 100 sickle cell or thalassemia patients who are age 12 or older who have access to a smartphone or tablet with Internet access daily. Patients enrolled in this study will be ask to use a mobile device such as a smartphone or a tablet with Android or iOS operating system to record daily pain level and related information once daily or more frequently for a period of forty-two days. A 1:1 randomization assignment will be made to have patients receive automated "canned" provider feedback or not.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 100 Years

Eligibility

Inclusion Criteria:

• SCD, thalassemia, or history of experiencing pain

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Chronic Pain
• Sickle Cell Disease

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability	Patients are able to use a mobile device to record daily symptoms, including pain, and interventions, including medication administration.	42 days