Pressure Injury Prediction and Education Model Using a Mobile Application System

NCT05357391 | Unknown

• 1 other identifier: 110-113-E
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Injury; Wound

Keywords

Pressure injury; Wound prediction model; Mobile application system; Knowledge of wound care; Self-efficacy; Anxiety; Depression

Outcome Measures

Primary Outcomes (4)

• 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.

  Data will be collected on admission(baseline-T0) and before discharge(T1).

• 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.

  Data will be collected on admission(baseline-T0) and before discharge(T1).

• 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.

  Data will be collected on admission(baseline-T0) and before discharge(T1).

• 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.

  Data will be collected on admission(baseline-T0) and before discharge(T1).

Secondary Outcomes (1)

• the satisfaction score of the smart care platform regarding pressure injury care

  Data will be collected before discharge(T1).

Study Arms (2)

The pressure injury prediction and education model group

EXPERIMENTAL

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.

Device: The Pressure Injury Prediction and Education model using a mobile application system

The control group

NO INTERVENTION

Routine care

Interventions

The Pressure Injury Prediction and Education model using a mobile application system DEVICE

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.

The pressure injury prediction and education model group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch: lead
• National Taipei University of Nursing and Health Sciences: collaborator

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

RECRUITING

Related Publications (6)

• Ahmad Zubaidi ZS, Ariffin F, Oun CTC, Katiman D. Caregiver burden among informal caregivers in the largest specialized palliative care unit in Malaysia: a cross sectional study. BMC Palliat Care. 2020 Dec 8;19(1):186. doi: 10.1186/s12904-020-00691-1.

  PMID: 33292214 BACKGROUND

• Govina O, Vlachou E, Kalemikerakis I, Papageorgiou D, Kavga A, Konstantinidis T. Factors Associated with Anxiety and Depression among Family Caregivers of Patients Undergoing Palliative Radiotherapy. Asia Pac J Oncol Nurs. 2019 Jul-Sep;6(3):283-291. doi: 10.4103/apjon.apjon_74_18.

  PMID: 31259225 BACKGROUND

• 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.

  PMID: 27305182 BACKGROUND

• Wang Y, Chen R, Ding J, Yang L, Chen J, Huang B. Predictive value of pressure ulcer risk for obstructive coronary artery disease. Nurs Open. 2021 Jul;8(4):1848-1855. doi: 10.1002/nop2.835. Epub 2021 Mar 6.

  PMID: 33675186 BACKGROUND

• 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.

  PMID: 28428158 BACKGROUND

• Drew DA, Nguyen LH, Steves CJ, Menni C, Freydin M, Varsavsky T, Sudre CH, Cardoso MJ, Ourselin S, Wolf J, Spector TD, Chan AT; COPE Consortium. Rapid implementation of mobile technology for real-time epidemiology of COVID-19. Science. 2020 Jun 19;368(6497):1362-1367. doi: 10.1126/science.abc0473. Epub 2020 May 5.

  PMID: 32371477 BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer; Wounds and Injuries; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Tzu-Ling Wu, BS

  National Taiwan University Hospital Hsin-Chu Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzu-Ling Wu, BS

CONTACT

+886928577465; a95937@gmail.com

Chun-Yi Tai, Ph.D

CONTACT

+886-228227101; yii@ntunhs.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. pressure injury prediction and education model group 2. control group

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: May 2, 2022
• Study Start: March 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)