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Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03643991
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Janette C. Leal, Mayo Clinic

Brief Summary:
Hospitalized patients with dementia and aggression and/or agitation will be given a weighted blanket to see if there are significant reductions in agitated and aggressive behaviors compared to treatment as usual.

Condition or disease Intervention/treatment Phase
Dementia Other: Weighted Blanket Not Applicable

Detailed Description:

The Intervention Group (Cohort 1 - first 15 patients to be enrolled):

  1. Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained.
  2. Nursing staff will complete baseline assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.
  3. A weighted blanket, based on admission body weight, will be provided to the patient under nursing supervision.
  4. For 3 consecutive days after each use of weighted blanket, nursing staff will complete morning assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.
  5. At the end of the intervention, nursing staff will complete post-intervention assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.

Control Group (Cohort 2 - second 15 patients to be enrolled):

  1. Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained.
  2. The study team will recruit a group of patients with similar characteristics as described in the inclusion criteria; however, the patient will not receive the weighted blanket, but undergo the same assessments as described in 1-5 (above) and in the Schedule of Assessments.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: First 15 subjects enrolled in the study will be given the weighted blanket treatment and the second 15 subjects will be a control cohort.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets: A Pilot Study
Actual Study Start Date : April 11, 2018
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Weighted Blanket Cohort
First 15 subjects enrolled have access to sleep with weighted blanket for three nights with monitoring by nurse. Weight of blanket is determined by weight of the patient (10% of patients body weight).
Other: Weighted Blanket
Weighted blanket will be given to patients based on the patient weight (10% of patients body weight) for three nights while on inpatient unit.

No Intervention: Control Cohort
Last 15 subjects enrolled receive treatment as usual while inpatient.



Primary Outcome Measures :
  1. Cohen-Mansfield Agitation Inventory Short Version (CMAI) Change [ Time Frame: At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket ]
    Assess the agitation/aggression outcome using numeric scales ranging from 1-5. The sum of the scores is defined as the agitation/aggression outcome and ranges from 14-70, with the lower score being the better outcome.


Secondary Outcome Measures :
  1. The revised Edmonton Symptom Assessment System Revised (ESAS-r) Change [ Time Frame: At baseline and within 72 hours of the last use of the weighted blanket. ]
    Assessment of symptoms in palliative patients using numeric analog scales ranging from 0 to 10 to assess levels of pain, tiredness, drowsiness, nausea, appetite, shortness of breath, depression, anxiety, and well-being. The sum of the scores for all symptoms is defined as the symptom distress score. The range of the sum is 0-100, with a lower score indicating a better outcome. The ESAS-r is a validated tool and publicly available for use.

  2. Clinical Global Impressions (CGI) [ Time Frame: At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket ]
    Aggression/Agitation as a measure of the global clinical outcome using a numeric scale ranging from 1-7, with a lower score indicating a better outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients admitted on the inpatient geriatric psychiatry unit, age 60 years and older.
  2. Diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.
  3. Presence of agitation/aggression symptoms as defined by a minimum aggression score on the Cohen-Mansfield Agitation Inventory Short Version (CMAI): a score ≥ 4 on at least one aggressive item.

Exclusion Criteria:

  1. Inability to remove blanket;
  2. Severe pain exacerbated by use of weighted blanket;
  3. Skin burns or open wounds;
  4. Allergy to blanket material.
  5. Admitted on 72 hour hold.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643991


Contacts
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Contact: Monica Walton 507-422-0689 walton.monica@mayo.edu
Contact: Kristina Dammen 507-255-0761 dammen.kristina@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Janette C Leal         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Janette C Leal, M.D Mayo Clinic
Additional Information:
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Responsible Party: Janette C. Leal, Principle Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03643991    
Other Study ID Numbers: 17-009951
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janette C. Leal, Mayo Clinic:
Agitation
Dementia
Inpatient
Additional relevant MeSH terms:
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Dementia
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations