Factors to Affect the Provision of Health Data of Users T... | NCT05036382

Studies
Factors to Affect the Provision of Health Data of Users Through PHR App

NCT05036382

Sponsor

Seoul National University Bundang Hospital

Status

Unknown status

Last Update Posted

Sep 5, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Personal Health Record

Interventions

Steps data observation

Countries

South Korea

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

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 25, 2021Estimated

Primary Completion Date

Sep 2021Estimated

Completion Date

Oct 2021Estimated

First Submitted Date

Aug 30, 2021

First Submission Date that Met QC Criteria

Aug 30, 2021

First Posted Date

Sep 5, 2021Actual

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

Aug 30, 2021

Last Update Posted Date

Sep 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

An experiment to determine if the incentive message affects people's active health data sharing.

Detailed Description

Researchers send a weekly message to participants asking them to share their step data on their personal health records(PHR) applications. (4months in total)

(Baseline, 1month) For the first month, researchers send the same data request message to both counties.

term, 1 month) The researchers added a message saying, 'Incentives are provided for data sharing' only to the experimental group.
term, 1 month) Excludes incentive message for both groups
term, 1 month) The researchers added a message saying, 'Incentives are provided for data sharing' only to the control group.
- For equity in both groups, an incentive message was provided to the control group in the last month under the same conditions as the experimental group.
- Only the first 3 months of data were used for the study.

Hypothesis

In 1-term, the number of data sharing in the experimental group is higher than that in the control group.
In 1-term, the number of data sharing in the experimental group is more active than baseline period.
In 2-term, the number of data sharing in the experimental group is still higher than in the baseline period.
Over the next 1 month, the number of sharing in the experimental group was maintained, which was still higher than that of the control group.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Group		A group that receives an incentive message one month after the start of the experiment	Behavioral: Steps data observation
Control Group		A group that does not receive an incentive message (for equity, incentive messages will be sent in the last month of the experiment)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Steps data observation	Behavioral	Sending more step data from the experimental group that received the incentive message	Experimental Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average number of data shares	The average number of steps data sharing between the experimental group and the control group according to the incentive message	3 months

Secondary Outcomes

Measure	Description	Time Frame
Percentage of participants with increased number of shares compared to baseline-term		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults aged 19 to 70
A person who has no difficulty in installing and using PHR app under study
A person who has expressed his/her willingness to participate voluntarily

Exclusion Criteria:

Children/Adolescents under the age of 18 or Seniors over 71 years of age
Those who do not have a smartphone or who are not proficient in using a smartphone
Persons who are uncooperative and difficult to understand the research method due to cognitive decline

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

People with smartphones that have no problems installing and using health applications

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Gyeonggi-do	Bundang-gu, Seongnam-si	13620	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided