Use of a Mobile-based App for SCD Patients

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Chronic Pain Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

SCD, thalassemia, or history of experiencing pain

Exclusion criteria

none

Treatment and study plan

Primary outcomes

Usability

Time frame: 42 days

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Use of a Mobile-based Pain Assessment Application for SCD Patients

Acronym: SMART

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Apr 17, 2013
Registry last updated: Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed