Clinical trial NCT05357391: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pressure Injury
Wound
Keywords: Pressure injury
Wound prediction model
Mobile application system
Knowledge of wound care
Self-efficacy
Anxiety
Depression
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
Collaborators: name: National Taipei University of Nursing and Health Sciences
First posted: 2022-05-02
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. pressure injury prediction and education model group
2. control group
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from the baseline score of the knowledge of pressure injury care to before discharge
timeFrame: Data will be collected on admission(baseline-T0) and before discharge(T1).
measure: Change from the baseline score of the pressure injury care self-efficacy of caregivers to before discharge
timeFrame: Data will be collected on admission(baseline-T0) and before discharge(T1).
measure: Change from the baseline score of the General Anxiety Disorder-7(GAD-7) to before discharge
timeFrame: Data will be collected on admission(baseline-T0) and before discharge(T1).
measure: Change from the baseline score of the Patient Health Questionnaire-9(PHQ-9) to before discharge
timeFrame: Data will be collected on admission(baseline-T0) and before discharge(T1).
Secondary outcomes:
measure: the satisfaction score of the smart care platform regarding pressure injury care
timeFrame: Data will be collected before discharge(T1).
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch
Study officials:
affiliation: National Taiwan University Hospital Hsin-Chu Branch
name: Tzu-Ling Wu, BS
role: PRINCIPAL_INVESTIGATOR
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