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DementiaAGITATENCT05691569

Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients

A study testing doll therapy in people with Dementia, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Dementia
What is being tested?
doll therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteSwitzerland
Study dates
15 Nov 2024to 30 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Patrizia D Amelio, MD, PhD contact

+41213143712

patrizia.damelio@chuv.ch

Switzerland1 site, 1 recruiting

  • geriatric and Geriatric Rehabilitation Unit

    Lausanne, Canton of Vaud, 1011

    Patrizia D'Amelio, MD, PhD, +41213143712, patrizia.damelio@chuv.ch

    Recruiting

Other trials in Switzerland

About this study

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

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.

Conditions
Dementia
Being tested
doll therapy
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • doll therapyOther

    empathy dolls

Study groups in NCT05691569
Study groupRoleWhat they receive
doll therapyExperimentalThe doll used in the study is the "empathy doll"; these dolls are designed to obtain an optimal interaction with patients and to arouse empathy
Receives: Other: doll therapy
non anthropomorphic objectOthernon- anthropomorphic soft object
Receives: Other: doll therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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

    Measured: baseline, 1 and 4 weeks after discharge

Secondary outcomes (5)

  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

    Measured: 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

    Measured: baseline and 4 weeks after discharge

  3. 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

    Measured: baseline and 4 weeks after discharge

  4. 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.

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

  5. family caregiver burden

    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

    Measured: baseline and 4 weeks after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2023
  2. Study start15 Nov 2024
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized controlled open label trial with two parallel arms
Masking
None (open label)
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05691569
Sponsor's protocol ID
agitate
Acronym
AGITATE
Status last verified
Apr 2025
First submitted
29 Nov 2022
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Martin-Garcia A, Corregidor-Sanchez AI, Fernandez-Moreno V, Alcantara-Porcuna V, Criado-Alvarez JJ. Effect of Doll Therapy in Behavioral and Psychological Symptoms of Dementia: A Systematic Review. Healthcare (Basel). 2022 Feb 23;10(3):421. doi: 10.3390/healthcare10030421.

    PubMed 35326899

  • Molteni V, Vaccaro R, Ballabio R, Ceppi L, Cantu M, Ardito RB, Adenzato M, Poletti B, Guaita A, Pezzati R. Doll Therapy Intervention Reduces Challenging Behaviours of Women with Dementia Living in Nursing Homes: Results from a Randomized Single-Blind Controlled Trial. J Clin Med. 2022 Oct 24;11(21):6262. doi: 10.3390/jcm11216262.

    PubMed 36362489

  • James IA, Reichelt K, Shirley L, Moniz-Cook E. Management of Agitation in Behaviours That Challenge in Dementia Care: Multidisciplinary Perspectives on Non-Pharmacological Strategies. Clin Interv Aging. 2023 Feb 18;18:219-230. doi: 10.2147/CIA.S399697. eCollection 2023.

    PubMed 36843632

  • Peng Y, Liu Y, Guo Z, Zhang Y, Sha L, Wang X, He Y. Doll therapy for improving behavior, psychology and cognition among older nursing home residents with dementia: A systematic review and meta-analysis. Geriatr Nurs. 2024 Jan-Feb;55:119-129. doi: 10.1016/j.gerinurse.2023.10.025. Epub 2023 Nov 19.

    PubMed 37980780

  • Santagata F, Massaia M, D'Amelio P. The doll therapy as a first line treatment for behavioral and psychologic symptoms of dementia in nursing homes residents: a randomized, controlled study. BMC Geriatr. 2021 Oct 12;21(1):545. doi: 10.1186/s12877-021-02496-0.

    PubMed 34641791

Questions about this trial

What is this clinical trial studying?

A study testing doll therapy in people with Dementia, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Patrizia D Amelio, MD, PhD (+41213143712, patrizia.damelio@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

agitation and aggressiveness within hospital (time frame: baseline and hospital discharge discharge (up to one week)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05691569, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.

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