Pressure InjuryNCT05357391
Pressure Injury Prediction and Education Model Using a Mobile Application System
A study testing The Pressure Injury Prediction and Education model using a mobile application system in people with Pressure Injury and Wound, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
Trial 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%. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury, Wound
- What is being tested?
- The Pressure Injury Prediction and Education model using a mobile application system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The primary caregiver has a mental or cognitive impairment, cannot express consciousness clearly, or cannot operate mobile apps.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu
Tzu-Ling Wu, BS, +886928577465, a95937@gmail.com
About this study
Official title: Clinical Study of Pressure Injury Wound Prediction Model Using a Mobile Application System for Caring and Managing
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.
Read the 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.
- Conditions
- Pressure Injury, Wound
- Being tested
- The Pressure Injury Prediction and Education model using a mobile application system
- Keywords
- Pressure injury, Wound prediction model, Mobile application system, Knowledge of wound care, Self-efficacy, Anxiety, Depression
- Medical subject headings
- Pressure Ulcer, Wounds and Injuries, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Pressure Injury Prediction and Education model using a mobile application systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: The Pressure Injury Prediction and Education model using a mobile application system |
| The control group | No intervention | Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Data will be collected before discharge(T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Mar 2022
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. pressure injury prediction and education model group 2. control group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Responsible party
- Sponsor
- Investigators
- Tzu-Ling Wu, BS, Principal investigator, National Taiwan University Hospital Hsin-Chu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357391
- Sponsor's protocol ID
- 110-113-E
- Status last verified
- Apr 2022
- First submitted
- 5 Jan 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33292214Govina 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.
PubMed 31259225Santos 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.
PubMed 27305182Wang 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.
PubMed 33675186Fishbein 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.
PubMed 28428158Drew 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.
PubMed 32371477
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Pressure Injury Wound Prediction Model Using a Mobile Application System for Caring and Managing
- ClinicalTrials.gov ID
- NCT05357391
- Acronym / sponsor ID
- 110-113-E
- Conditions
- Pressure Injury, Wound
- Keywords
- Pressure injury, Wound prediction model, Mobile application system, Knowledge of wound care, Self-efficacy, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 1. pressure injury prediction and education model group 2. control group
| Arm | Type | Receives |
|---|---|---|
| The pressure injury prediction and education model group | Experimental | Device: The Pressure Injury Prediction and Education model using a mobile application systemThe 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. |
| The control group | No intervention | –Routine care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- The primary caregiver has a mental or cognitive impairment, cannot express consciousness clearly, or cannot operate mobile apps.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Pressure Injury Prediction and Education model using a mobile application systemData 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. | Device | The pressure injury prediction and education model group |
Primary outcome
Change from the baseline score of the knowledge of pressure injury care to before discharge
Time frame: Data will be collected on admission(baseline-T0) and before discharge(T1).
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
Time frame: Data will be collected on admission(baseline-T0) and before discharge(T1).
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
Time frame: Data will be collected on admission(baseline-T0) and before discharge(T1).
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
Time frame: Data will be collected on admission(baseline-T0) and before discharge(T1).
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.
1 secondary outcome
the satisfaction score of the smart care platform regarding pressure injury care
Time frame: Data will be collected before discharge(T1).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Background: PubMed 33292214Ahmad 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.
- Background: PubMed 31259225Govina 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.
- Background: PubMed 27305182Santos 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.
- Background: PubMed 33675186Wang 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.
- Background: PubMed 28428158Fishbein 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.
- Background: PubMed 32371477Drew 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tzu-Ling Wu, BS principal investigator
National Taiwan University Hospital Hsin-Chu Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Pressure Injury Prediction and Education model using a mobile application system in people with Pressure Injury and Wound, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzu-Ling Wu, BS (+886928577465, a95937@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the baseline score of the knowledge of pressure injury care to before discharge (time frame: Data will be collected on admission(baseline-T0) and before discharge(T1).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05357391, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.