search
Back to results

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

Primary Purpose

Dementia, Agitation,Psychomotor

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Calming Touch
Sponsored by
University College Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Distrikt Oest.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Calming Touch

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Hair cortisol levels
Hair samples will be collected and cortisol levels will be analyzed

Full Information

First Posted
December 17, 2021
Last Updated
September 6, 2023
Sponsor
University College Copenhagen
Collaborators
TrygFonden, Denmark
search

1. Study Identification

Unique Protocol Identification Number
NCT05272501
Brief Title
CAlming Touch for People With Agitation or Other Behavioural Symptoms of DEMentia - A Randomized Feasibility Trial
Acronym
CADEM
Official Title
CAlming Touch for People With Agitation or Other Behavioural Symptoms of DEMentia - A Randomized Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College Copenhagen
Collaborators
TrygFonden, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Agitation,Psychomotor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calming Touch
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Calming Touch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Cohen-Mansfield Agitation Inventory (CMAI) from baseline to 4, 8, and 12 weeks after baseline.
Description
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
Time Frame
CMAI will be performed 2 weeks before baseline, at baseline, and 4, 8, and 12 weeks post baseline.
Secondary Outcome Measure Information:
Title
The Erlangen Test for Activities of Daily Living (E-ADL-Test)
Description
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.
Time Frame
The E-ADL-Test will be performed at baseline, and 4, 8, and 12 weeks post baseline.
Title
Hair cortisol levels
Description
Hair samples will be collected and cortisol levels will be analyzed
Time Frame
Hair samples will be collected at baseline, and 4, 8, and 12 weeks post baseline.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonna Jensen, Ass. Prof.
Organizational Affiliation
University College Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Distrikt Oest.
City
Naestved
ZIP/Postal Code
4700
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs