Pressure Injury Prediction and Education Model Using a Mobile Application System

NCT ID: NCT05357391

Last Updated: 2022-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-11-30

Brief Summary

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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

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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.

Conditions

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Pressure Injury Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. pressure injury prediction and education model group
2. control group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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The pressure injury prediction and education model group

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.

Group Type EXPERIMENTAL

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

Intervention Type 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 control group

Routine care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role collaborator

National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tzu-Ling Wu, BS

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital Hsin-Chu Branch

Locations

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National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tzu-Ling Wu, BS

Role: CONTACT

+886928577465

Chun-Yi Tai, Ph.D

Role: CONTACT

+886-228227101 ext. 3171

Facility Contacts

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Tzu-Ling Wu, BS

Role: primary

+886928577465

References

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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.

Reference Type BACKGROUND
PMID: 33292214 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31259225 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27305182 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33675186 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28428158 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32371477 (View on PubMed)

Other Identifiers

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110-113-E

Identifier Type: -

Identifier Source: org_study_id

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