Effect of the Mobile Self-input Tool of Incentive Spirometer (RCT)

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.

Study Overview

• Status: Completed
• Conditions: Gastrectomy
• Intervention / Treatment: Other: Alarm; Other: Nurse's dashboard

Detailed Description

1. 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.

2. 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.
3. Design: RCT (randomized controlled trial)
4. Setting: In the Department of Gastrointestinal Surgery at the Samsung Medical Center
5. Enrollment : 44 patients undergoing gastrectomy.

6. 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.

7. 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)
8. Study period : for 48hrs from one day to 3rd day after patient's operation
9. Satisfaction survey (SUS) after study(3rd day after operation)

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam
    • Seoul, Gangnam, Korea, Republic of, 06351
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; Participants will receive the mobile self-input tool providing alarm on tablet, and their practicing rate will be sent to Nurse's Dashboard.	Other: Alarm; Alarm is provided from 9am to 9pm.; Alarm is active every 50 minutes if the exercise goal(10 times/hour) hasn't satisfied.; Other: Nurse's dashboard; Wireless data transmission system; The practicing rate of participants on study group is sent to Nurse's Dashboard.; It is only to display.
No Intervention: Control Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collecting subject's medical records related to pulmonary complication	such as body temperature, laboratory results and Chest X-ray.	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)	3rd day after operation

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Samsung Electronics
• Investigators: Principal Investigator: Wonchul Cha, Doctoral, Samsung Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2018
• Primary Completion (Actual): May 17, 2018
• Study Completion (Actual): July 10, 2018

Study Registration Dates

• First Submitted: May 25, 2018
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 14, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Incentive Spirometer
• Other Study ID Numbers: 2018-02-135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No