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

Delirium Clinical Trial

Official title:

The Feasibility and Acceptability of Using Weighted Blankets to Prevent and/or Mitigate Delirium in Adult Critical Care Patients in Urban and Rural Settings.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06161480
• Other study ID #: HM20027241
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2023
• Est. completion date: August 29, 2024

Study information

• Verified date: December 2023
• Source: Virginia Commonwealth University
• Contact: Heather Fudala, PhD
• Phone: 804-432-8944
• Email: heather.fudala[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 29, 2024
• Est. primary completion date: August 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium

Intervention

Device:
• Weighted Blanket
Weighted Blanket is an occupational therapy modality which has been associated with significant increases in grounding, orientation to reality, soothing, and quality of life.

Locations

Country	Name	City	State
United States	VCU Health Systems	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Participants Experience Survey	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.	Six months
Primary	LAR Experience Survey	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.	Six Months
Primary	Nurse and Provider Experience Survey	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.	Six Months
Secondary	Analysis of total ICU Length of Stay (Days)	Study Team will collect data daily and conduct analysis of total ICU Length of Stay (Days).	Six Months.
Secondary	Analysis of total ICU Length of Stay on Study (Days)	Study Team will collect data daily and conduct analysis of total ICU Length of Stay on Study (Days)	Six Months
Secondary	Analysis of total Number of Ventilator Days (This admission)	Study Team will collect data daily and conduct analysis of total Number of Ventilator Days (This admission).	Six Months
Secondary	Analysis of total number of Ventilator Days on Study	Study Team will collect data daily and conduct analysis of total number of Ventilator Days on Study.	Six Months
Secondary	Daily Chart Review	Study Team will collect data daily and conduct analysis of the daily chart review data.	Six Months
Secondary	Blanket Usage Log analysis	Study Team will collect data daily and conduct analysis of the Blanket Usage Log.	Six Months
Secondary	Confusion Assessment Method for the ICU (CAM-ICU) data analysis	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).	Six Months