Hemophilia Mobile App Usability Pilot

NCT03168685 | Unknown FDA Device

• 1 other identifier: Pro00021564
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the utility and user experience of a smart phone app for people with medical conditions, used in conjunction with an ActiGraph wearable device and a connected scale.

Conditions

Hemophilia

Keywords

smartphones; clinical trials; weight; actigraph; tracking; hemophilia

Outcome Measures

Primary Outcomes (2)

• Usage of the SureSource Engage application as assessed by ActiLife software

  128 days

• Device usability as assessed by the System Usability Scale (SUS)

  128 days

Study Arms (1)

Experimental

EXPERIMENTAL

Multiple device intervention 1. SureSource Engage mobile application 2. ActiGraph Link 3. weight scale

Device: SureSource Engage application

Interventions

SureSource Engage application DEVICE

Eligible patients who choose to participate in the study will be asked to wear an actigraphy device \[ActiGraph GT9X Link "Actigraph Link"\] on their wrist continuously during both 4-week study phases. The ActiGraph Link is a small (3.5 X 3.5 X 1 cm) wristwatch like device weighing approximately 14 grams that measures indicators of the wearer's activity and sleep patterns, including: acceleration, energy expenditure, steps, basal metabolic rate, activity intensity, sleep time, sleep efficiency, sleep latency, and body position. The application being utilized is SureSource Engage application from Clinical Ink. The application is compatible to most Android and iOS devices. Participants will also use a basic Bluetooth-enabled weight scale that syncs with the application.

Also known as: ActiGraph GT9X Link, weight scale

Experimental

Eligibility Criteria

• Age: 18 Years - 63 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• You own an iPhone or a Samsung (S5 or higher) smartphone
• Your age is between 18 and 63 years
• You reside in the New York metropolitan area
• You are able to read, write, and speak English
• You have participated in a concluded clinical trial in the past two years

You may not qualify if:

• You do not own an iPhone or a Samsung (S5 or higher) smartphone
• Your age is not between 18 and 63 years
• You do not reside in the New York metropolitan area
• You are not able to read, write, and speak English
• You have not participated in a concluded clinical trial in the past two years

Sponsors & Collaborators

• Healthcare Innovation Technology Lab: lead
• Bayer: collaborator

Study Sites (1)

Healthcare Innovation and Technology Lab

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Hemophilia A; Body Weight

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stan Kachnowski, PhD, MPA

  Healthcare Innovation Technology Lab

  PRINCIPAL INVESTIGATOR

• Ryan Dammerman, MD

  Healthcare Innovation Technology Lab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 30, 2017
• Study Start: May 22, 2017
• Primary Completion: May 11, 2018
• Study Completion: May 11, 2018
• Last Updated: April 19, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)