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

Dementia Clinical Trial

Official title:

Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets: A Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03643991
• Other study ID #: 17-009951
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 11, 2018
• Est. completion date: March 2026

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Psychomotor Agitation

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohen-Mansfield Agitation Inventory Short Version (CMAI) Change	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.	At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket
Secondary	The revised Edmonton Symptom Assessment System Revised (ESAS-r) Change	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.	At baseline and within 72 hours of the last use of the weighted blanket.
Secondary	Clinical Global Impressions (CGI)	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.	At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket

External Links

•   Mayo Clinic Clinical Trials