Clinical trial NCT05272501: CAlming Touch for People With Agitation or Other Behavioural Symptoms of DEMentia - A Randomized Feasibility Trial
Official title: CAlming Touch for People With Agitation or Other Behavioural Symptoms of DEMentia - A Randomized Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Agitation,Psychomotor
Lead sponsor: University College Copenhagen
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
First posted: 2022-03-09
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Dementia is an increasing health challenge among elderly citizens in Denmark. An estimated 87,000 Danes live with dementia, and this number is expected to increase to 130,000 in 2030. Psychiatric symptoms and behavioral changes decrease quality of life for patients and their spouses and is a challenge for caretakers. Behavior changes include agitation which can be divided in four sub-groups: 1) physical aggression, 2) physical non-aggression, 3) verbal aggression, and 4) verbal non-aggression. Pharmaceutical management of behavioral changes is common and may be associated with negative side-effects including drowsiness and falls. Though non-pharmaceutical interventions such as music, massage and social activities have been recommended the underlying evidence is limited. In this randomized feasibility trial, we will investigate the feasibility and acceptability of therapeutic touch aiming to reduce agitated behavior in people living with dementia in a nursing home that specializes in the care of people living with severe dementia.

The success criteria of this randomized feasibility trial are as follows:

1. Nursing home residents can be recruited and accept the treatment 'CAlming Touch for People with Agitation or Other Behavioral Symptoms of DEMentia' (CADEM) and complete the feasibility project's test protocol.
2. The treatment concept, which involves the nursing staff in charge of the follow-up treatment, can be implemented in practice.
3. The treatment (CADEM) shows a tendency towards less restless and aggressive behavior for demented citizens evaluated based on a validated measuring tool.


Eligibility criteria: Inclusion Criteria:

* Citizens who are residents of the care center due to dementia
* Citizens living at a care center in Naestved Municipality
* Demented citizens who exhibit agitated / aggressive behavior (nursing staff observe whether the citizen exhibits agitated behavior within at least one of the subgroups

Exclusion Criteria:

* Citizens in palliative care
* Citizens who have received BBAUM treatment within the last month

Primary outcomes:
measure: Change in Cohen-Mansfield Agitation Inventory (CMAI) from baseline to 4, 8, and 12 weeks after baseline.
timeFrame: CMAI will be performed 2 weeks before baseline, at baseline, and 4, 8, and 12 weeks post baseline.
Secondary outcomes:
measure: The Erlangen Test for Activities of Daily Living (E-ADL-Test)
timeFrame: The E-ADL-Test will be performed at baseline, and 4, 8, and 12 weeks post baseline.
measure: Hair cortisol levels
timeFrame: Hair samples will be collected at baseline, and 4, 8, and 12 weeks post baseline.
Other outcomes:
Locations:
city: Naestved
country: Denmark
facility: Distrikt Oest.
Study officials:
affiliation: University College Copenhagen
name: Jonna Jensen, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References: