Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients
ConditionDementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCentre Hospitalier Universitaire Vaudois
About this trial
Summary. Behavioral and psychological symptoms of dementia (BPSD) represents a huge emotional stress and an important burden for the patients and the caregivers severely reducing their quality of life. BPSD worsen during hospitalization and require the administration of psychotropic drugs that are often insufficient to control the symptoms, and may cause severe adverse events.
The investigators propose the use of empathy dolls in order to reduce BPSD and in particular agitation and aggressiveness in acute geriatric in-patients affected by moderate to severe forms of dementia.
The use of doll therapy in the clinical routine will allow to reduce the use of psychotropic drugs, shorten hospitalization, reduce professional and family caregiver burden improving patients' and families' quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age ≥65 years
diagnosis of dementia moderate to severe Clinical Dementia Rating scale (CDR) ≥2
presence of agitation and/or aggressiveness
manual and visual abilities sufficient in order to interact with the doll.
Disqualifiers
age <65 years;
refuse to participate;
mild forms of dementia (CDR<2);
contraindication for DT as experience of mournful or traumatic events related to parental experience;
Trial design
Design model
Parallel
Treatments tested in this trial
doll therapy
Other interventionempathy dolls
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: doll therapyExperimental treatment 1 intervention
Group B: non anthropomorphic objectOther 1 intervention
Trial outcomes
Primary outcomes
1
agitation and aggressiveness within hospital
measured by Pittsburgh Agitation Scale (PAS). the score ranges between 0 to 16 on the PAS the higher score means the higher agitation
Time frame
baseline and hospital discharge discharge (up to one week)2
behavioural and psychological symptoms of dementia
Neuro Psychiatic Inventory (NPI). The NPI total score ranges from 0 to 144, higher scores means more severe and frequent behavioural and psycological symptoms of dementia
Time frame
baseline, discharge (up to one week)3
agitation and aggressiveness outside hospital
Cohen Mansfield Inventory scale (CMAI). the score ranges betwen 0 and 203, with higher scores indicating more agitation
Time frame
baseline, 1 and 4 weeks after dischargeSecondary outcomes
1
incidence of delirium
measured by the Confusion Assessment Method (CAM) scale. For a diagnosis of delirium by CAM, the patient must display: 1. Presence of acute onset and fluctuating discourse AND 2. Inattention AND EITHER 3. Disorganized thinking OR 4. Altered level of consciousness
Time frame
every day during hospital stay (up to one week)2
patients' quality of life
by the use of the AD-5D Dementia Utility Instrument, the scales scores between -1 to 1, the highest score indicate the better quality of life
Time frame
baseline and 4 weeks after discharge3
family caregivers' quality of life
by the EuroQoL 5-Dimensions 5 level versions. the scale scores from 5 to 25 the highest the score the lowest the quality of life
Time frame
baseline and 4 weeks after discharge4
professional caregiver burden
Staff Stress Measure Dementia Care (SSMDC). The scale comprised the following 27 items producing a five-factor solution: Frustrated empathy; difficulties understanding and interpreting; balancing competing needs; balancing emotional involvement; and lack of recognition.
Time frame
baseline and at hospital discharge (up to one week)Sponsors and contacts
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Source ClinicalTrials.gov