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| Name | Class |
|---|---|
| TrygFonden, Denmark | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonna Jensen, Ass. Prof. | University College Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Distrikt Oest. | Næstved | 4700 | Denmark |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| 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. |
| D001523 | Mental Disorders |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |