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Use of a Mobile-based App for SCD Patients (SMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01833702
Recruitment Status : Completed
First Posted : April 17, 2013
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date April 13, 2013
First Posted Date April 17, 2013
Last Update Posted Date July 16, 2019
Actual Study Start Date June 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 13, 2013)
Usability [ Time Frame: 42 days ]
Patients are able to use a mobile device to record daily symptoms, including pain, and interventions, including medication administration.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Use of a Mobile-based App for SCD Patients
Official Title Use of a Mobile-based Pain Assessment Application for SCD Patients
Brief 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.

Detailed 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients experiencing pain or patients with sickle cell disease
Condition
  • Sickle Cell Disease
  • Chronic Pain
Intervention Not Provided
Study Groups/Cohorts
  • Automated response
    Canned responses are provided at the end of daily entries
  • No automated feedback
    Canned responses are not provided at the end of daily entries
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 15, 2019)
21
Original Estimated Enrollment
 (submitted: April 13, 2013)
100
Actual Study Completion Date May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • SCD, thalassemia, or history of experiencing pain

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01833702
Other Study ID Numbers Pro00037857
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Duke University
Original Responsible Party Jude C. Jonassaint, Duke University, RN
Current Study Sponsor Duke University
Original Study Sponsor Jude C. Jonassaint
Collaborators Not Provided
Investigators
Principal Investigator: Jude Jonassaint, RN Duke University
Principal Investigator: Laura De Castro, MD Duke University
Principal Investigator: Nirmish Shah, MD Duke University
PRS Account Duke University
Verification Date November 2018