Hemophilia Mobile App Usability Pilot

NCT ID: NCT03168685

Last Updated: 2018-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-22

Study Completion Date

2018-05-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

HITLAB will conduct a segmented rapid user acceptance study ("rapid UX study") of a smart phone app and an actigraphy device with a connected scale. During the first segment, of one month's duration, subjects will use the app, actigraphy device, and scale. Next, over an interphase period of up to 6 weeks, subjects will only use the app. During this time, the app will be modified based on data collected during the first segment. Finally, during the second period, also of one month's duration, subjects will use the modified app, actigraphy device, and scale.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemophilia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

Multiple device intervention

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

Group Type EXPERIMENTAL

SureSource Engage application

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SureSource Engage application

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ActiGraph GT9X Link weight scale

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

63 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role collaborator

Healthcare Innovation Technology Lab

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stan Kachnowski, PhD, MPA

Role: PRINCIPAL_INVESTIGATOR

Healthcare Innovation Technology Lab

Ryan Dammerman, MD

Role: PRINCIPAL_INVESTIGATOR

Healthcare Innovation Technology Lab

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Healthcare Innovation and Technology Lab

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00021564

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hemlibra in Mild Hemophilia A
NCT04567511 RECRUITING PHASE4
ATHN 2: Factor Switching Study
NCT02546622 COMPLETED