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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

Study Description
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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
Sickle Cell Disease Chronic Pain

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
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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 : June 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Usability [ Time Frame: 42 days ]
    Patients are able to use a mobile device to record daily symptoms, including pain, and interventions, including medication administration.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients experiencing pain or patients with sickle cell disease
Criteria

Inclusion Criteria:

  • SCD, thalassemia, or history of experiencing pain

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833702


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Jude Jonassaint, RN Duke University
Principal Investigator: Laura De Castro, MD Duke University
Principal Investigator: Nirmish Shah, MD Duke University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01833702    
Other Study ID Numbers: Pro00037857
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: November 2018
Keywords provided by Duke University:
Sickle cell
Pain
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Chronic Pain
Pain
Neurologic Manifestations
Anemia, Hemolytic, Congenital
 Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn