GastrectomyNCT03569332
Effect of the Mobile Self-input Tool of Incentive Spirometer (RCT)
A study testing Alarm and Nurse's dashboard in people with Gastrectomy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study evaluates the effectiveness of the mobile self-input tool providing alarm and visual motivation, how much more it can encourage practicing of incentive spirometer undergoing post-operative patients under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrectomy
- What is being tested?
- Alarm and Nurse's dashboard
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Apr 2018to 10 Jul 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject undergoing total gastrectomy or subtotal gastrectomy by robotic surgery, laparoscopic surgery or open surgery
- A subject who got surgery under general anesthesia
- A Subject receiving a prescription of using incentive spirometer
- A subject who voluntarily agrees and signs
Who cannot join
- Disorientation
- Unscheduled emergency surgery
- a subject who has difficulty in active breathing exercise due to problems such as heart disease, brain disease, chronic lung disease, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Mobile Self-input Tool of Incentive Spirometer on Its Usage by Patients : a Randomized Clinical Trial
This study evaluates the effectiveness of the mobile self-input tool providing alarm and visual motivation, how much more it can encourage practicing of incentive spirometer undergoing post-operative patients under general anesthesia. Half of participants will receive the mobile self-input tool providing alarm, and their practicing rate will be sent to Nurse's Dashboard. While the other half will receive the mobile self-input tool, but it won't contain alarm function and their practicing rate won't be sent to Nurse's Dashboard, either.
Read the detailed description
- Background : Active respiratory therapy like incentive spirometer is needed to prevent pulmonary complications for patients undergoing post-operative under general anesthesia. But in many cases, patients don't practicing it for their pain, or they just forget doing it. And medical staffs are having difficulties in checking how well the patients follow the directions for doing incentive spirometer. Insufficient practicing incentive spirometer and deep breathing cause delay their health recovery. Therefore, we want to make some tools which can encourage the patients' practicing for incentive spirometer and also supply the objective achievement of patients to medical staffs.
- Objective : This study evaluates the effectiveness of the mobile self-input tool providing alarm and visual motivation, how much more it can encourage practicing of incentive spirometer undergoing post-operative patients under general anesthesia.
- Design: RCT (randomized controlled trial)
- Setting: In the Department of Gastrointestinal Surgery at the Samsung Medical Center
- Enrollment : 44 patients undergoing gastrectomy.
- Intervention 6-1) For study group : participants on study group are received self-input tool with alarm system on tablet. Alarm is provided only if insufficient practice (less than 10 times/hour) from 9am to 9pm. The practicing rate is sent to Nurse's Dashboard. 6-2) For control group : participants on control group are received self-input tool without alarm on tablet. Their practicing rate is not sent to Nurse's Dashboard.
- Scoring by practicing incentive spirometer from 9 am to 9 pm. (Only when a subject practiced more than 10 times per hour, the subject get 10 points) (Full score 240)
- Study period : for 48hrs from one day to 3rd day after patient's operation
- Satisfaction survey (SUS) after study(3rd day after operation)
- Conditions
- Gastrectomy
- Being tested
- Alarm, Nurse's dashboard
- Keywords
- Incentive Spirometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlarmOther
- Alarm is provided from 9am to 9pm.
- Alarm is active every 50 minutes if the exercise goal(10 times/hour) hasn't satisfied.
Nurse's dashboardOther
- Wireless data transmission system
- The practicing rate of participants on study group is sent to Nurse's Dashboard.
- It is only to display.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Participants will receive the mobile self-input tool providing alarm on tablet, and their practicing rate will be sent to Nurse's Dashboard. Receives: Other: Alarm; Other: Nurse's dashboard |
| Control Group | No intervention | Participants will receive the mobile self-input tool on tablet (to compare the rate with Test group). But it won't contain alarm function and their practicing rate won't be sent to Nurse's Dashboard, either. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of practicing incentive spirometer that subjects input by themselves on the mobile self-input tool and scoring by practicing incentive spirometer from 9 am to 9 pm.
Only when a subject practiced more than 10 times per hour, the subject get 10 points
Measured: Only collecting the numbers of practicing between 9 am and 9 pm for two days, from 1st day to 3rd day after operation.
Secondary outcomes (2)
Collecting subject's medical records related to pulmonary complication
such as body temperature, laboratory results and Chest X-ray.
Measured: From one day after subject's operation to the date the subject leaves(discharges) the hospital. (Average duration is for 4~5days)
Satisfaction Survey for mobile self-input tool
Scoring by the answers of the Questionnaire of Satisfaction (SUS)
Measured: 3rd day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start16 Apr 2018
- Primary completion17 May 2018
- Study completion10 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastrectomyStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Electronics
- Responsible party
- Sponsor
- Investigators
- Wonchul Cha, Doctoral, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569332
- Sponsor's protocol ID
- 2018-02-135
- Status last verified
- Jun 2018
- First submitted
- 25 May 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Soh JY, Lee SU, Lee I, Yoon KS, Song C, Kim NH, Sohn TS, Bae JM, Chang DK, Cha WC. A Mobile Phone-Based Self-Monitoring Tool for Perioperative Gastric Cancer Patients With Incentive Spirometer: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Feb 19;7(2):e12204. doi: 10.2196/12204.
PubMed 30777844
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Mobile Self-input Tool of Incentive Spirometer on Its Usage by Patients : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03569332
- Acronym / sponsor ID
- 2018-02-135
- Conditions
- Gastrectomy
- Keywords
- Incentive Spirometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Samsung Electronics
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 17 May 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 26 Jun 2018 (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.
This study evaluates the effectiveness of the mobile self-input tool providing alarm and visual motivation, how much more it can encourage practicing of incentive spirometer undergoing post-operative patients under general anesthesia. Half of participants will receive the mobile self-input tool providing alarm, and their practicing rate will be sent to Nurse's Dashboard. While the other half will receive the mobile self-input tool, but it won't contain alarm function and their practicing rate won't be sent to Nurse's Dashboard, either.
Detailed description
- Background : Active respiratory therapy like incentive spirometer is needed to prevent pulmonary complications for patients undergoing post-operative under general anesthesia. But in many cases, patients don't practicing it for their pain, or they just forget doing it. And medical staffs are having difficulties in checking how well the patients follow the directions for doing incentive spirometer. Insufficient practicing incentive spirometer and deep breathing cause delay their health recovery. Therefore, we want to make some tools which can encourage the patients' practicing for incentive spirometer and also supply the objective achievement of patients to medical staffs.
- Objective : This study evaluates the effectiveness of the mobile self-input tool providing alarm and visual motivation, how much more it can encourage practicing of incentive spirometer undergoing post-operative patients under general anesthesia.
- Design: RCT (randomized controlled trial)
- Setting: In the Department of Gastrointestinal Surgery at the Samsung Medical Center
- Enrollment : 44 patients undergoing gastrectomy.
- Intervention 6-1) For study group : participants on study group are received self-input tool with alarm system on tablet. Alarm is provided only if insufficient practice (less than 10 times/hour) from 9am to 9pm. The practicing rate is sent to Nurse's Dashboard. 6-2) For control group : participants on control group are received self-input tool without alarm on tablet. Their practicing rate is not sent to Nurse's Dashboard.
- Scoring by practicing incentive spirometer from 9 am to 9 pm. (Only when a subject practiced more than 10 times per hour, the subject get 10 points) (Full score 240)
- Study period : for 48hrs from one day to 3rd day after patient's operation
- Satisfaction survey (SUS) after study(3rd day after operation)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Other: Alarm, Other: Nurse's dashboardParticipants will receive the mobile self-input tool providing alarm on tablet, and their practicing rate will be sent to Nurse's Dashboard. |
| Control Group | No intervention | –Participants will receive the mobile self-input tool on tablet (to compare the rate with Test group). But it won't contain alarm function and their practicing rate won't be sent to Nurse's Dashboard, either. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A subject undergoing total gastrectomy or subtotal gastrectomy by robotic surgery, laparoscopic surgery or open surgery
- A subject who got surgery under general anesthesia
- A Subject receiving a prescription of using incentive spirometer
- A subject who voluntarily agrees and signs
Key exclusion criteria (3 listed)
- Disorientation
- Unscheduled emergency surgery
- a subject who has difficulty in active breathing exercise due to problems such as heart disease, brain disease, chronic lung disease, etc.
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 |
|---|---|---|
| Alarm1. Alarm is provided from 9am to 9pm. 2. Alarm is active every 50 minutes if the exercise goal(10 times/hour) hasn't satisfied. | Other | Test Group |
| Nurse's dashboard1. Wireless data transmission system 2. The practicing rate of participants on study group is sent to Nurse's Dashboard. 3. It is only to display. | Other | Test Group |
Primary outcome
Total number of practicing incentive spirometer that subjects input by themselves on the mobile self-input tool and scoring by practicing incentive spirometer from 9 am to 9 pm.
Time frame: Only collecting the numbers of practicing between 9 am and 9 pm for two days, from 1st day to 3rd day after operation.
Only when a subject practiced more than 10 times per hour, the subject get 10 points
2 secondary outcomes
Collecting subject's medical records related to pulmonary complication
Time frame: From one day after subject's operation to the date the subject leaves(discharges) the hospital. (Average duration is for 4~5days)
Satisfaction Survey for mobile self-input tool
Time frame: 3rd day after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Derived from this study: PubMed 30777844Soh JY, Lee SU, Lee I, Yoon KS, Song C, Kim NH, Sohn TS, Bae JM, Chang DK, Cha WC. A Mobile Phone-Based Self-Monitoring Tool for Perioperative Gastric Cancer Patients With Incentive Spirometer: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Feb 19;7(2):e12204. doi: 10.2196/12204.
- Individual participant dataSharing planned: Undecided
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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.
Wonchul Cha, Doctoral principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alarm and Nurse's dashboard in people with Gastrectomy, run by Samsung Medical Center 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 4 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: finished, as of the sponsor's last update on 17 Jul 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total number of practicing incentive spirometer that subjects input by themselves on the mobile self-input tool and scoring by practicing incentive spirometer from 9 am to 9 pm. (time frame: Only collecting the numbers of practicing between 9 am and 9 pm for two days, from 1st day to 3rd day after operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03569332, which also lists 1 linked publication.
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 17 Jul 2018.