Clinical trial NCT03643991: Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets
Official title: Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Dementia
Keywords: Agitation
Dementia
Inpatient
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enrolled patients will be computer randomized in 1:1 ratio to either the intervention group or the control group.
Primary purpose: TREATMENT

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.

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.

Eligibility 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:

* Severe pain likely to be exacerbated by use of weighted blanket
* Inability to remove blanket;
* Skin burns or open wounds;
* Admitted on 72 hour hold.

Primary outcomes:
measure: Cohen-Mansfield Agitation Inventory Short Version (CMAI) Change
timeFrame: At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket
Secondary outcomes:
measure: The revised Edmonton Symptom Assessment System Revised (ESAS-r) Change
timeFrame: At baseline and within 72 hours of the last use of the weighted blanket.
measure: Clinical Global Impressions (CGI)
timeFrame: At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Maria Lapid, MD
role: PRINCIPAL_INVESTIGATOR
References: