NCT01833702

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 16, 2019

Status Verified

November 1, 2018

Enrollment Period

1.9 years

First QC Date

April 13, 2013

Last Update Submit

July 15, 2019

Conditions

Sickle Cell DiseaseChronic Pain

Keywords

Sickle cellPain

Outcome Measures

Primary Outcomes (1)

  • Usability

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

    42 days

Study Arms (2)

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

Eligibility Criteria

Age12 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients experiencing pain or patients with sickle cell disease

You may qualify if:

  • SCD, thalassemia, or history of experiencing pain

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Anemia, Sickle CellChronic PainPain

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jude Jonassaint, RN

    Duke University

    PRINCIPAL INVESTIGATOR

  • Laura De Castro, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Nirmish Shah, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2013

First Posted

April 17, 2013

Study Start

June 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 16, 2019

Record last verified: 2018-11

Locations

US(1)