Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets
NCT ID: NCT03643991
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-04-11
2025-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
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.
Control Cohort
Subjects will receive treatment as usual while inpatient, no blanket.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
60 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Maria I. Lapid, M.D.
Principle Investigator
Principal Investigators
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Maria Lapid, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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References
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Schenzel HA, Palmer AK, Shah NB, Lawson DK, Fischer KM, Lapid MI, DeFoster RE. Weighted Blankets for Agitation in Hospitalized Patients with Dementia: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Feb 26;14:e57264. doi: 10.2196/57264.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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17-009951
Identifier Type: -
Identifier Source: org_study_id