Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets
- Conditions
- Dementia
- Interventions
- Other: Weighted Blanket
- Registration Number
- NCT03643991
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Weighted Blanket Cohort Weighted Blanket 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).
- Primary Outcome Measures
Name Time Method Cohen-Mansfield Agitation Inventory Short Version (CMAI) Change At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket 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.
- Secondary Outcome Measures
Name Time Method The revised Edmonton Symptom Assessment System Revised (ESAS-r) Change At baseline and within 72 hours of the last use of the weighted blanket. 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.
Clinical Global Impressions (CGI) At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket 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.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States