- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05272501
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:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jonna Jensen, Ass. Prof.
- Phone Number: + 45 51380532
- Email: joaj@kp.dk
Study Contact Backup
- Name: Jacob Uth, PhD
- Phone Number: +45 51632579
- Email: jaut@kp.dk
Study Locations
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Naestved, Denmark, 4700
- Distrikt Oest.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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.
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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.
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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.
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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.
Time Frame: CMAI will be performed 2 weeks before baseline, at baseline, and 4, 8, and 12 weeks post baseline.
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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
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CMAI will be performed 2 weeks before baseline, at baseline, and 4, 8, and 12 weeks post baseline.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Erlangen Test for Activities of Daily Living (E-ADL-Test)
Time Frame: The E-ADL-Test will be performed at baseline, and 4, 8, and 12 weeks post baseline.
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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.
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The E-ADL-Test will be performed at baseline, and 4, 8, and 12 weeks post baseline.
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Hair cortisol levels
Time Frame: Hair samples will be collected at baseline, and 4, 8, and 12 weeks post baseline.
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Hair samples will be collected and cortisol levels will be analyzed
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Hair samples will be collected at baseline, and 4, 8, and 12 weeks post baseline.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jonna Jensen, Ass. Prof., University College Copenhagen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200576
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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