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

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Agitation,Psychomotor
• Intervention / Treatment: Behavioral: Calming Touch

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Naestved, Denmark, 4700
    • Distrikt Oest.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Calming Touch; 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; 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.
No Intervention: Usual care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Erlangen Test for Activities of Daily Living (E-ADL-Test)	The Erlangen Test of Activities of Daily Living (E-ADL-Test) consists of five items: pouring a drink, cutting a piece of bread, opening a small cupboard, washing hands and tying a bow. Each test item underwent standardized evaluation on a scale of 0 to 6.	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 and cortisol levels will be analyzed	Hair samples will be collected at baseline, and 4, 8, and 12 weeks post baseline.

Collaborators and Investigators

• Sponsor: University College Copenhagen
• Collaborators: TrygFonden, Denmark
• Investigators: Principal Investigator: Jonna Jensen, Ass. Prof., University College Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): December 22, 2022
• Study Completion (Actual): December 22, 2022

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation; Dementia; Behavioral Symptoms
• Other Study ID Numbers: 200576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No