CAlming Touch for People With Agitation or Other Behavioural Symptoms of DEMentia - A Randomized Feasibility Trial

NCT05272501 | Completed DMC

• 1 other identifier: 200576
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 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. 2.The treatment concept, which involves the nursing staff in charge of the follow-up treatment, can be implemented in practice.
3. 3.The treatment (CADEM) shows a tendency towards less restless and aggressive behavior for demented citizens evaluated based on a validated measuring tool.

Conditions

Dementia; Agitation,Psychomotor

Outcome Measures

Primary Outcomes (1)

• Change in Cohen-Mansfield Agitation Inventory (CMAI) from baseline to 4, 8, and 12 weeks after baseline.

  The Cohen-Mansfield Agitation Inventory (CMAI; Cohen-Mansfield, 1986) is a 29-item questionnaire designed to measure the types and frequencies of agitated behaviors exhibited by elderly nursing home residents

  CMAI will be performed 2 weeks before baseline, at baseline, and 4, 8, and 12 weeks post baseline.

Secondary Outcomes (2)

• The Erlangen Test for Activities of Daily Living (E-ADL-Test)

  The E-ADL-Test will be performed at baseline, and 4, 8, and 12 weeks post baseline.

• Hair cortisol levels

  Hair samples will be collected at baseline, and 4, 8, and 12 weeks post baseline.

Study Arms (2)

Calming Touch

EXPERIMENTAL

The calming treatment consists of deep pressure massage and gentle facilitation. The therapist works with the vertical axis, center, respiration, body boundaries and the feet.

Behavioral: Calming Touch

Usual care

NO INTERVENTION

The usual care group may participate in usual activities at the nursing home e.g. physio- and occupational therapy, listening to calming music, holdning hands with care-takers.

Interventions

Calming Touch BEHAVIORAL

The calming treatment consists of deep pressure massage and gentle facilitation. The therapist works with the vertical axis, center, respiration, body boundaries and the feet.

Calming Touch

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University College Copenhagen: lead
• TrygFonden, Denmark: collaborator

Study Sites (1)

Distrikt Oest.

Næstved, 4700, Denmark

Location

MeSH Terms

Conditions

Dementia; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Jonna Jensen, Ass. Prof.

  University College Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: March 9, 2022
• Study Start: October 4, 2021
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)