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

Launched by MAYO CLINIC · Aug 21, 2018

Keywords

ClinConnect Summary

This Mayo Clinic pilot study is testing whether using a weighted blanket can help reduce agitation and other distressing symptoms in people with dementia who are in the hospital. In the study, eligible participants are randomly assigned to either receive a weighted blanket (about 10% of their body weight) for three nights with nurse supervision, or to receive usual inpatient care without a blanket. Researchers will track changes in agitation using a standard scale (CMAI) and also look at overall well‑being and other symptoms (using ESAS-r and CGI). The study is designed so participants and staff know which treatment is being given (no masking).

Who may be eligible? Adults aged 60 and older with dementia (or suspected major neurocognitive disorder) who show agitation or aggression and have a legally authorized representative who can consent. Exclusions include conditions that might be worsened by the blanket (like severe pain), inability to remove the blanket, skin injuries, or certain admission holds. If eligible, you’d sign consent, undergo baseline assessments, wear the weighted blanket for three nights with daily checks, and have a final assessment after the intervention. The trial is based at Mayo Clinic in Rochester, Minnesota, plans to enroll about 30 people, started in 2018, and is currently enrolling by invitation with completion expected in 2026. Results are not available yet.

Gender

ALL

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.