Feasibility and Acceptability of Using Weighted Blankets to Prevent and /or Mitigate Delirium

Not Applicable

Recruiting

• Conditions: Delirium
• Interventions: Device: Weighted Blanket

• Registration Number: NCT06161480
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

The use of weighted blankets to avert or alleviate Delirium in Adult ICU patients.

Detailed Description

To examine the feasibility and acceptability of weighted blankets as a single component, nonpharmacologic strategy to prevent and/or mitigate delirium in an adult medicine critical care patient population. To examine the feasibility and acceptability of videoconferencing (VCU Health Zoom), EHR screening, and VCU and VCU Health infrastructure (REDCap, OnCore) for rural participant recruitment and research participation, remote HealthCare provider protocol training and research engagement, and remote research monitoring and support for rural patient population. To collect preliminary descriptive data and examine trends related to the use of weighted blankets to prevent and/or mitigate delirium to inform future efficacy trials in an adult medicine critical care patient population (e.g., Agitation, Delirium, ICU length of stay, number ventilator days, sedation/opioid medication usage).

Study Timeline

• Study Start: 2023-10-06
• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-04-29
• Study Completion: 2025-04-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 18 years of age or older.
• Requiring ICU level of care.
• Have a primary medical diagnosis.
• Proficient in English.

Exclusion Criteria

• BMI less than 18.5.
• Significant deficit in cognitive functioning that is not expected to improve due to an end---stage disease stage or permanent injury (e.g., end-stage encephalopathy, traumatic or anoxic brain injury, dementia).
• Known pregnancy.
• Prisoners.
• Presence of skin injury (e.g., surgical wound, pressure injury, moisture injury) in an anatomical location where additional weight/pressure of blanket could prevent healing and /or lead to an expansion of the injury.
• Patients with skin injuries to areas easily left uncovered by the blanket (e.g., hands, feet) can be enrolled with additional communication to clinical team to leave areas uncovered to prevent additional injury.
• Paralysis effecting an area the weighted blanket will cover.
• Current neuromuscular blocking agent.
• Presence of recent/unhealed fractures on an area the blanket will cover (e.g., lower limb long bone, rib, pelvis, spine).
• History of claustrophobia reported by patient and/or their legally authorized representative (LAR).
• Fever of 37.5°C (99.5°F).
• Limited English proficiency.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Weighted Blanket	Weighted Blanket	To prevent and or mitigate delirium in adult ICU patients in urban and rural populations.

Primary Outcome Measures

Name	Time	Method
Study Participants Experience Survey	Six months	Study Participants will be asked to complete a survey describing their experience with using the weighted blanket upon discharge from the ICU or if they stop using the weighted blanket, to determine if participants felt using the weighted blanket was beneficial to their overall health improvement.
LAR Experience Survey	Six Months	LAR will complete survey describing his/her perspective of the participant's use of the weighted blanket to improve family member's health outcome. LAR will complete survey after participant has been discharged from ICU or participant is no longer using the weighted blanket.
Nurse and Provider Experience Survey	Six Months	The nurse and healthcare provider will complete surveys once their patient has completed the use of the weighted blanket describing whether they felt the weighted blanket improved the health outcome of their patients.

Secondary Outcome Measures

Name	Time	Method
Blanket Usage Log analysis	Six Months	Study Team will collect data daily and conduct analysis of the Blanket Usage Log.
Confusion Assessment Method for the ICU (CAM-ICU) data analysis	Six Months	Study Team will collect data daily and conduct analysis of data from the CAM-ICU, a rating scale used be bedside clinicians to assess delirium for patients in the intensive care unit. The CAM-ICU-7 evaluates the presence of acute onset or fluctuating course (score of 0 or 1), inattention (score ranges from 0-2), altered level of consciousness (score ranges from 0-2, based on if RASS is anything other than alert and calm \[zero\]), and disorganized thinking (score ranges from 0-2).
Analysis of total ICU Length of Stay on Study (Days)	Six Months	Study Team will collect data daily and conduct analysis of total ICU Length of Stay on Study (Days)
Daily Chart Review	Six Months	Study Team will collect data daily and conduct analysis of the daily chart review data.
Analysis of total ICU Length of Stay (Days)	Six Months.	Study Team will collect data daily and conduct analysis of total ICU Length of Stay (Days).
Analysis of total Number of Ventilator Days (This admission)	Six Months	Study Team will collect data daily and conduct analysis of total Number of Ventilator Days (This admission).
Analysis of total number of Ventilator Days on Study	Six Months	Study Team will collect data daily and conduct analysis of total number of Ventilator Days on Study.

Trial Locations

Locations (1)

VCU Health Systems; 🇺🇸 Richmond, Virginia, United States