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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06161480
Other study ID # HM20027241
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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