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NCT Number: NCT05691569

Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

geriatric and Geriatric Rehabilitation Unit

Lausanne, Canton of Vaud, 1011, Switzerland

Location status: Recruiting

Location contact

Patrizia D'Amelio, MD, PhD

CONTACT

[email protected]

+41213143712

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • life expectancy lower than 3 months;
  • infectious diseases requiring isolation;
  • negative interaction with the doll,
  • presence of delirium.

Treatment and study plan

doll therapy

Other

empathy dolls

Primary outcomes

  1. agitation and aggressiveness within hospital

    Time frame: baseline and hospital discharge discharge (up to one week)

    measured by Pittsburgh Agitation Scale (PAS). the score ranges between 0 to 16 on the PAS the higher score means the higher agitation

  2. behavioural and psychological symptoms of dementia

    Time frame: baseline, discharge (up to one week)

    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

  3. agitation and aggressiveness outside hospital

    Time frame: baseline, 1 and 4 weeks after discharge

    Cohen Mansfield Inventory scale (CMAI). the score ranges betwen 0 and 203, with higher scores indicating more agitation

Secondary outcomes

  1. incidence of delirium

    Time frame: every day during hospital stay (up to one week)

    measured by the Confusion Assessment Method (CAM) scale. For a diagnosis of delirium by CAM, the patient must display:

    • Presence of acute onset and fluctuating discourse AND
    • Inattention AND EITHER
    • Disorganized thinking OR
    • Altered level of consciousness

  2. patients' quality of life

    Time frame: baseline and 4 weeks after discharge

    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

  3. family caregivers' quality of life

    Time frame: baseline and 4 weeks after discharge

    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

  4. professional caregiver burden

    Time frame: baseline and at hospital discharge (up to one week)

    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.

  5. family caregiver burden

    Time frame: baseline and 4 weeks after discharge

    Caregiver Burden Inventory (CBI) scale. The Caregiver Burden Inventory comprises 24 closed questions divided into five dimensions: time-dependence, developmental, physical, social and emotional burden. There are five items in each dimension except for physical burden, which has four items dedicated to. Each item is given a score between 0 (not at all descriptive) and 4 (very descriptive), where higher scores indicate greater caregiver burden; there are no cut-off points for classifying burden. Therefore, total scores for factors one, two, four and five can range from zero to 20. An equivalent score for physical burden can be obtained by multiplying the sum of items in this dimension by 1.25

Study contacts

Contact information is provided by the study sponsor or research team.

Patrizia D Amelio, MD, PhD

CONTACT

[email protected]

+41213143712

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

Efficacy of Doll Therapy in the Control of Behavioral and psychologIcal Symptoms of Dementia in Acute Geriatric Inpatients: the AGITATE Study.

Acronym: AGITATE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2023
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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