Tokyo, Sept. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062998) titled 'Nursing research on the prevention of self-removal of intravenous drips and tubes by older people with cognitive decline' on Sept. 20.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Chiba University
Condition:
Condition - Risk of self-removal among older people with cognitive decline
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - With a view to minimizing the use of physical restraints on older people with cognitive impairment, this study evaluates the use of a contact detection system by clinical nurses and examines the potential for the removal of physical restraints through the use of this system.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Participating nurses will be asked to use the contact detection system for approximately three months. We will compare the occurrence and duration of physical restraint removal between the group using the system and the group not using it (control_2). We will also evaluate the system's detection rate, failure rate and number of false alarms, as well as the nurses' perceptions of the system.
Interventions/Control_2 - Control group. This group will be monitored for approximately three months, without the use of a contact detection system, to determine whether physical restraints have been removed.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Ward nurses
Those who have been briefed on the study and have obtained the patient's consent.
Those who have been briefed on the system and are able to use it.
Target patients
Elderly patients with intravenous drips or tubes in place who are at risk of self-removal, such as those with impaired cognitive function or a history of removal.
Patients who have been briefed on the study and for whom consent has been obtained from the patient themselves or a key person involved in decision-making.
Patients for whom the attending doctor or ward manager has determined that the system can be used.
Key exclusion criteria - Ward Nurse
A nursing manager who does not provide direct care to patients.
Target Patients
Those who do not have key persons involved in decision-making, such as family members.
Target Size - 50
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2024 Year 03 Month 04 Day
Date of IRB - 2024 Year 03 Month 04 Day
Anticipated trial start date - 2024 Year 05 Month 08 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072120
Disclaimer: Curated by HT Syndication.