SMART: Use of a Mobile-based App for SCD Patients

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT01833702
Collaborator
(none)
21
1
23
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    21 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Use of a Mobile-based Pain Assessment Application for SCD Patients
    Actual Study Start Date :
    Jun 1, 2012
    Actual Primary Completion Date :
    May 1, 2014
    Actual Study Completion Date :
    May 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Usability [42 days]

      Patients are able to use a mobile device to record daily symptoms, including pain, and interventions, including medication administration.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • SCD, thalassemia, or history of experiencing pain
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Medical Center Durham North Carolina United States 27710

    Sponsors and Collaborators

    • Duke University

    Investigators

    • Principal Investigator: Jude Jonassaint, RN, Duke University
    • Principal Investigator: Laura De Castro, MD, Duke University
    • Principal Investigator: Nirmish Shah, MD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT01833702
    Other Study ID Numbers:
    • Pro00037857
    First Posted:
    Apr 17, 2013
    Last Update Posted:
    Jul 16, 2019
    Last Verified:
    Nov 1, 2018
    Keywords provided by Duke University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 16, 2019