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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01833702
First received: April 13, 2013
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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
Sickle Cell Disease
Chronic Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of a Mobile-based Pain Assessment Application for SCD Patients

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Usability [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Patients are able to use a mobile device to record daily symptoms, including pain, and interventions, including medication administration.


Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833702

Contacts
Contact: Christle cameron, LPN 9196846464 christle.cameron@dm.duke.edu
Contact: Jude Jonassaint, RN 9196686035 jude.jonassaint@dm.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Jude Jonassaint, RN    919-668-6035    jude.jonassaint@dm.duke.edu   
Contact: Laura De Castro, MD    9196846464    laura.decastro@dm.duke.edu   
Principal Investigator: Jude Jonassaint, RN         
Sub-Investigator: Laura De Castro, MD         
Sub-Investigator: Nirmish Shah, MD         
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
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01833702     History of Changes
Other Study ID Numbers: Pro00037857
Study First Received: April 13, 2013
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Sickle cell
Pain

Additional relevant MeSH terms:
Anemia, Sickle Cell
Chronic Pain
Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014