NCT03569332

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2018

Completed
Last Updated

July 17, 2018

Status Verified

June 1, 2018

Enrollment Period

1 month

First QC Date

May 25, 2018

Last Update Submit

July 14, 2018

Conditions

Gastrectomy

Keywords

Incentive Spirometer

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    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

    3rd day after operation

Study Arms (2)

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.

Other: AlarmOther: 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.

Interventions

AlarmOTHER

1. Alarm is provided from 9am to 9pm. 2. Alarm is active every 50 minutes if the exercise goal(10 times/hour) hasn't satisfied.

Test Group
Nurse's dashboardOTHER

1. 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.

Test Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam, 06351, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 30777844DERIVED

MeSH Terms

Interventions

Clinical Alarms

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and Supplies

Study Officials

  • Wonchul Cha, Doctoral

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2018

First Posted

June 26, 2018

Study Start

April 16, 2018

Primary Completion

May 17, 2018

Study Completion

July 10, 2018

Last Updated

July 17, 2018

Record last verified: 2018-06

Locations

KR(1)