Personal Health RecordNCT05036382
Factors to Affect the Provision of Health Data of Users Through PHR App
An observational study of Personal Health Record, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
An experiment to determine if the incentive message affects people's active health data sharing. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Personal Health Record
- What is being tested?
- Steps data observation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Aug 2021to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with smartphones that have no problems installing and using health applications
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Gyeonggi-do, Bundang-gu, Seongnam-si, 13620
About this study
Official title: A Study on Analysis of Factors to Affect the Provision of Health Data of Users Through the Personal Health Management Application
An experiment to determine if the incentive message affects people's active health data sharing.
Read the 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.
- Conditions
- Personal Health Record
- Being tested
- Steps data observation
- Keywords
- PHR, Incentive Mechanism, Token Economy, Data Sharing, Lifelog data, RCT, Personal Health Record, Health Mobile app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steps data observationBehavioural
Sending more step data from the experimental group that received the incentive message
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | A group that receives an incentive message one month after the start of the experiment Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
Percentage of participants with increased number of shares compared to baseline-term
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start25 Aug 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personal Health RecordStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036382
- Sponsor's protocol ID
- clinical trials_1
- Status last verified
- Jun 2021
- First submitted
- 30 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Analysis of Factors to Affect the Provision of Health Data of Users Through the Personal Health Management Application
- ClinicalTrials.gov ID
- NCT05036382
- Acronym / sponsor ID
- clinical trials_1
- Conditions
- Personal Health Record
- Keywords
- PHR, Incentive Mechanism, Token Economy, Data Sharing, Lifelog data, RCT, Personal Health Record, Health Mobile app
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 25 Aug 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Behavioral: Steps data observationA group that receives an incentive message one month after the start of the experiment |
| 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) |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with smartphones that have no problems installing and using health applications
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steps data observationSending more step data from the experimental group that received the incentive message | Behavioural | Experimental Group |
Primary outcome
Average number of data shares
Time frame: 3 months
The average number of steps data sharing between the experimental group and the control group according to the incentive message
1 secondary outcome
Percentage of participants with increased number of shares compared to baseline-term
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Personal Health Record, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of data shares (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.