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Weighted Blankets for Dementia-Related Agitation
N/A
Waitlist Available
Led By Janette C Leal, M.D
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients admitted on the inpatient geriatric psychiatry unit, complex interventions unit, internal medicine service and/or admitted hospice GIP
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, days 1-3, and then within 72 hours of last use of the weighted blanket
Awards & highlights
Study Summary
This trial will test whether weighted blankets help reduce agitation and aggression in patients with dementia who are hospitalized.
Who is the study for?
This trial is for patients with dementia who are experiencing agitation. They must be in a geriatric psychiatry unit, complex interventions unit, internal medicine service or admitted hospice GIP. A documented diagnosis of dementia and a certain level of aggression on the CMAI scale are required. Patients need someone legally authorized to consent on their behalf.Check my eligibility
What is being tested?
The study is testing if using weighted blankets can help calm people with dementia and reduce symptoms like agitation. Participants will use these blankets to see if there's an improvement in their behavior compared to usual care without them.See study design
What are the potential side effects?
Potential side effects may include discomfort due to the weight of the blanket, skin irritation, or worsening pain if already present. However, those with severe pain or skin issues have been excluded from this trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am admitted for geriatric psychiatry, complex care, internal medicine, or hospice.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and within 72 hours of the last use of the weighted blanket.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and within 72 hours of the last use of the weighted blanket.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohen-Mansfield Agitation Inventory Short Version (CMAI) Change
Secondary outcome measures
Clinical Global Impressions (CGI)
The revised Edmonton Symptom Assessment System Revised (ESAS-r) Change
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Weighted Blanket CohortExperimental Treatment1 Intervention
Subjects will receive weighted blanket for three nights with monitoring by nurse. Weight of blanket is determined by weight of the patient (10% of patients body weight).
Group II: Control CohortActive Control1 Intervention
Subjects will receive treatment as usual while inpatient, no blanket.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,053 Total Patients Enrolled
25 Trials studying Dementia
17,067 Patients Enrolled for Dementia
Janette C Leal, M.DPrincipal InvestigatorMayo Clinic
Maria Lapid, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
38 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Using a weighted blanket will likely worsen my severe pain.I have skin burns or open wounds.If you have a certain level of aggressive behavior based on a specific questionnaire, you may not be able to participate.I am admitted for geriatric psychiatry, complex care, internal medicine, or hospice.I cannot remove a blanket by myself.You have been diagnosed with severe memory or thinking problems.
Research Study Groups:
This trial has the following groups:- Group 1: Weighted Blanket Cohort
- Group 2: Control Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applications still being considered for this research project?
"Affirmative. Clinicaltrials.gov has revealed that this research endeavour, initially posted on April 11th 2018, is actively seeking participants. Thirty people are required to join the study from 1 specified site."
Answered by AI
How many individuals can partake in this clinical experiment?
"Affirmative. Clinicaltrials.gov has the most recent information available, and it shows that this clinical trial is actively searching for participants since its initial posting on April 11th 2018. 30 subjects are needed to be recruited from one site."
Answered by AI
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