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Pressure Injury Prediction and Education Model Using a Mobile Application System

Primary Purpose

Pressure Injury, Wound

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
The Pressure Injury Prediction and Education model using a mobile application system
Sponsored by
National Taiwan University Hospital Hsin-Chu Branch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pressure Injury focused on measuring Pressure injury, Wound prediction model, Mobile application system, Knowledge of wound care, Self-efficacy, Anxiety, Depression

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. The primary caregiver for patients with pressure injury in the hospital.
  2. The primary caregiver must be at least 20 years old, have clear consciousness, express independently, communicate in Mandarin and Taiwanese, use an Android phone by himself, and use a mobile phone application after explanation.

Exclusion Criteria:

The primary caregiver has a mental or cognitive impairment, cannot express consciousness clearly, or cannot operate mobile apps.

Sites / Locations

  • National Taiwan University Hospital Hsin-Chu BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The pressure injury prediction and education model group

The control group

Arm Description

The experimental group will be provided a pressure injury prediction of the patient and personalized care information of pressure injury by a smart care platform. The participants (primary caregivers) will fill out the questionnaires online at admission (baseline-T0) and before the patient is discharged(T1). The questionnaires will collect the following data, including demographic information(only T0), knowledge, self-efficacy, anxiety, depression of wound care(T0&T1), and satisfaction of the smart care platform(only T1). The time to fill out the questionnaires will be about 10 minutes.

Routine care

Outcomes

Primary Outcome Measures

Change from the baseline score of the knowledge of pressure injury care to before discharge
The investigators designed the ten questions regarding pressure injury care knowledge to detect caregivers' understanding of pressure injury care. The higher scores reflect a greater understanding of pressure injury care.
Change from the baseline score of the pressure injury care self-efficacy of caregivers to before discharge
The fourteen items of the self-efficacy of pressure injury care are designed to detect caregivers' self-efficacy on pressure injury care. Response options on the items range from "no confidence" (1 point) to "every confidence" (5 points). The higher scores reflect greater self-efficacy on pressure injury care.
Change from the baseline score of the General Anxiety Disorder-7(GAD-7) to before discharge
The GAD-7 (Spitzer et al., 2006) is a one-dimensional instrument designed to detect generalized anxiety disorder symptoms defined in the DSM-IV. The item scores range from 0 (not at all) to 3 (nearly every day), resulting in a sum score ranging from 0 to 21. The higher scores reflect greater anxiety severity.
Change from the baseline score of the Patient Health Questionnaire-9(PHQ-9) to before discharge
The nine items of the PHQ-9 are designed to capture the nine Diagnostic and Statistical Manual of Mental Disorders (DSM) symptom criteria for a major depressive episode. Response options on the items range from "not at all" (0 points) to "nearly every day" (3 points). As a severity measure, the PHQ-9 score can range from 0 to 27.

Secondary Outcome Measures

the satisfaction score of the smart care platform regarding pressure injury care
The ten items of satisfaction with the smart care platform are designed to detect caregivers' satisfaction with this platform. Response options on the items range from "strongly disagree " (1 point) to "strongly agree" (5 points), resulting in a sum score ranging from 10 to 50.

Full Information

First Posted
January 5, 2022
Last Updated
April 27, 2022
Sponsor
National Taiwan University Hospital Hsin-Chu Branch
Collaborators
National Taipei University of Nursing and Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05357391
Brief Title
Pressure Injury Prediction and Education Model Using a Mobile Application System
Official Title
Clinical Study of Pressure Injury Wound Prediction Model Using a Mobile Application System for Caring and Managing
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital Hsin-Chu Branch
Collaborators
National Taipei University of Nursing and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pressure injuries are common in the elderly and patients who reduced physical activities. Its complications significantly impact the health care system and social burden, even causing the death rate to be as high as 68%. This study aims to collect medical data regarding pressure injuries during hospitalization for developing the Pressure Injury Prediction and Education Model using a mobile application system. It can offer a prediction on the risk of pressure injury and be used as a teaching aid for pressure injury care, providing a personalized and evidence-based nursing information platform for patients, caregivers, and health professionals.
Detailed Description
This study will conduct a randomized controlled trial among 160 primary caregivers of patients with pressure injuries. They will be randomly assigned to the control group or the experimental group. In the control group, patients are routinely cared for in the ward, and this group will have no intervention. Routine care includes face-to-face training and educational pamphlets by the ward nurse. The experimental group will be provided a pressure injury prediction of the patient and personalized care information of pressure injury by a smart care platform. The participants (primary caregivers) will fill out the questionnaires online at admission (baseline-T0)and before the patient is discharged(T1). The questionnaires will collect the following data, including demographic information(only T0), knowledge, self-efficacy, anxiety, depression of pressure injury care(T0&T1), and satisfaction of the smart care platform(only T1). The time to fill out the questionnaires will be about 10 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Injury, Wound
Keywords
Pressure injury, Wound prediction model, Mobile application system, Knowledge of wound care, Self-efficacy, Anxiety, Depression

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pressure injury prediction and education model group control group
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The pressure injury prediction and education model group
Arm Type
Experimental
Arm Description
The experimental group will be provided a pressure injury prediction of the patient and personalized care information of pressure injury by a smart care platform. The participants (primary caregivers) will fill out the questionnaires online at admission (baseline-T0) and before the patient is discharged(T1). The questionnaires will collect the following data, including demographic information(only T0), knowledge, self-efficacy, anxiety, depression of wound care(T0&T1), and satisfaction of the smart care platform(only T1). The time to fill out the questionnaires will be about 10 minutes.
Arm Title
The control group
Arm Type
No Intervention
Arm Description
Routine care
Intervention Type
Device
Intervention Name(s)
The Pressure Injury Prediction and Education model using a mobile application system
Intervention Description
Data from the medical records will be used to analyze the probability and risk of wound healing for creating a Pressure Injury Prediction and Education Model using a mobile application system.
Primary Outcome Measure Information:
Title
Change from the baseline score of the knowledge of pressure injury care to before discharge
Description
The investigators designed the ten questions regarding pressure injury care knowledge to detect caregivers' understanding of pressure injury care. The higher scores reflect a greater understanding of pressure injury care.
Time Frame
Data will be collected on admission(baseline-T0) and before discharge(T1).
Title
Change from the baseline score of the pressure injury care self-efficacy of caregivers to before discharge
Description
The fourteen items of the self-efficacy of pressure injury care are designed to detect caregivers' self-efficacy on pressure injury care. Response options on the items range from "no confidence" (1 point) to "every confidence" (5 points). The higher scores reflect greater self-efficacy on pressure injury care.
Time Frame
Data will be collected on admission(baseline-T0) and before discharge(T1).
Title
Change from the baseline score of the General Anxiety Disorder-7(GAD-7) to before discharge
Description
The GAD-7 (Spitzer et al., 2006) is a one-dimensional instrument designed to detect generalized anxiety disorder symptoms defined in the DSM-IV. The item scores range from 0 (not at all) to 3 (nearly every day), resulting in a sum score ranging from 0 to 21. The higher scores reflect greater anxiety severity.
Time Frame
Data will be collected on admission(baseline-T0) and before discharge(T1).
Title
Change from the baseline score of the Patient Health Questionnaire-9(PHQ-9) to before discharge
Description
The nine items of the PHQ-9 are designed to capture the nine Diagnostic and Statistical Manual of Mental Disorders (DSM) symptom criteria for a major depressive episode. Response options on the items range from "not at all" (0 points) to "nearly every day" (3 points). As a severity measure, the PHQ-9 score can range from 0 to 27.
Time Frame
Data will be collected on admission(baseline-T0) and before discharge(T1).
Secondary Outcome Measure Information:
Title
the satisfaction score of the smart care platform regarding pressure injury care
Description
The ten items of satisfaction with the smart care platform are designed to detect caregivers' satisfaction with this platform. Response options on the items range from "strongly disagree " (1 point) to "strongly agree" (5 points), resulting in a sum score ranging from 10 to 50.
Time Frame
Data will be collected before discharge(T1).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The primary caregiver for patients with pressure injury in the hospital. The primary caregiver must be at least 20 years old, have clear consciousness, express independently, communicate in Mandarin and Taiwanese, use an Android phone by himself, and use a mobile phone application after explanation. Exclusion Criteria: The primary caregiver has a mental or cognitive impairment, cannot express consciousness clearly, or cannot operate mobile apps.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tzu-Ling Wu, BS
Phone
+886928577465
Email
a95937@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Yi Tai, Ph.D
Phone
+886-228227101
Ext
3171
Email
yii@ntunhs.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tzu-Ling Wu, BS
Organizational Affiliation
National Taiwan University Hospital Hsin-Chu Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital Hsin-Chu Branch
City
Hsinchu
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tzu-Ling Wu, BS
Phone
+886928577465
Email
a95937@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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33292214
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
Santos CT, Almeida Mde A, Lucena Ade F. The Nursing Diagnosis of risk for pressure ulcer: content validation. Rev Lat Am Enfermagem. 2016 Jun 14;24:e2693. doi: 10.1590/1518-8345.0782.2693.
Results Reference
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Citation
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Results Reference
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Citation
Fishbein JN, Nisotel LE, MacDonald JJ, Amoyal Pensak N, Jacobs JM, Flanagan C, Jethwani K, Greer JA. Mobile Application to Promote Adherence to Oral Chemotherapy and Symptom Management: A Protocol for Design and Development. JMIR Res Protoc. 2017 Apr 20;6(4):e62. doi: 10.2196/resprot.6198.
Results Reference
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Citation
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Results Reference
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Pressure Injury Prediction and Education Model Using a Mobile Application System

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