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

Mayo Clinic

Status: Invitation-only

Conditions: Dementia

Treatments: Other: Weighted Blanket

Study type: Interventional

Funder types: Other

Identifiers

NCT03643991

17-009951

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Weighted Blanket Cohort

Experimental group

Description:

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).

Treatment:

Other: Weighted Blanket

Control Cohort

No Intervention group

Description:

Subjects will receive treatment as usual while inpatient, no blanket.