Use of a Mobile-based App for SCD Patients | NCT01833702

Studies
Use of a Mobile-based App for SCD Patients

NCT01833702

Sponsor

Duke University

Status

Completed

Last Update Posted

Jul 16, 2019Actual

Enrollment

21Actual

Phase

Not provided

Conditions

Sickle Cell Disease
Chronic Pain

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012Actual

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Apr 13, 2013

First Submission Date that Met QC Criteria

Apr 13, 2013

First Posted Date

Apr 17, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2019

Last Update Posted Date

Jul 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Usability	Patients are able to use a mobile device to record daily symptoms, including pain, and interventions, including medication administration.	42 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

SCD, thalassemia, or history of experiencing pain

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients experiencing pain or patients with sickle cell disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jude Jonassaint, RN	Duke University	Principal Investigator
Laura De Castro, MD	Duke University	Principal Investigator
Nirmish Shah, MD	Duke University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Medical Center		Durham	North Carolina	27710	United States

Condition Browse Module

MeSH Terms

ID	Term
D000755	Anemia, Sickle Cell
D059350	Chronic Pain
D010146	Pain

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided