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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03643991
Recruitment Status : Enrolling by invitation
First Posted : August 23, 2018
Last Update Posted : February 24, 2023
Sponsor:
Information provided by (Responsible Party):
Maria I. Lapid, M.D., Mayo Clinic

Study Description
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Brief Summary:
The purpose of this research study is to determine whether the use of weighted blankets help reduce behavioral and psychological symptoms, including agitation in people with dementia.

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

Detailed Description:

The Intervention Group

  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:

  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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Enrolled patients will be computer randomized in 1:1 ratio to either the intervention group or the control group.
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 2026
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Weighted Blanket Cohort
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).
 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
Subjects will receive treatment as usual while inpatient, no blanket.


Outcome Measures
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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.


Eligibility Criteria
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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:

  • Patients admitted on the inpatient geriatric psychiatry unit, complex interventions unit, internal medicine service and/or admitted hospice GIP
  • Documented diagnosis of dementia or suspected major neurocognitive disorder.
  • Presence of agitation/aggression symptoms as defined by a minimum aggression score on the Cohen-Mansfield Agitation Inventory Short Version (CMAI): Patients must score 3, 4, or 5 on at least one question related to aggression (items 1-4).
  • Have a LAR able to sign the consent on behalf of the patient.

Exclusion Criteria:

  • Inability to remove blanket;
  • Skin burns or open wounds;
  • Admitted on 72 hour hold.
Contacts and Locations
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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


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Maria Lapid, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Maria I. Lapid, M.D., 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: February 24, 2023
Last Verified: February 2023
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 Maria I. Lapid, M.D., 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