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CompletedNCT04635124Updated Nov 18, 2020

Optimal Dog Visits

An interventional study of Dog visit and Encourage to engage in activity in Dementia and Aging, sponsored by University of Aarhus. Completed. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-18.

Sponsored by University of Aarhus · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 5 years 10 months after the study started (first participant enrolled Jan 2015, registered Nov 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
186
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

The aim of this project is to study how an the intensity of dog contact during dog visits in nursing homes can affect the immediate response to, and the general effect of the visits, and whether the residents' level of cognitive impairment affects the response and benefit of dog visits.

The participants are randomly assigned to receive one type of visits (12 visits in total) out of three possible visit types (1: visit with a dog; 2: visit with a dog, including a planned activity, 3 visit without a dog, including a planned activity). The residents received 2 visits per week for 6 weeks. The behaviour of the participants during visits is recorded. Before and after the intervention period, participants are scores on psychometric scales for cognitive impairment level, daily function level and symptoms of depression.

02

Conditions studied

  • Dementia
  • Aging

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Keywords

  • Animal-assisted therapy
  • visiting dog
  • non-pharmacological
  • nursing home
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's enrollment of 186 is above the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Being able to sit up during the visits

Exclusion criteria

Exclusion Criteria:

  • Dog allergy
  • Fear of dogs
  • Health problems that make participation unadvisable
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
186 participants (actual)

Study arms

  • Active comparator
    1: Dog visit with a dog, no additional activity (D)

    The nursing home resident receives 12 10-minute visits in their own room. The visitor is accompanied with a dog, and the resident can touch the dog. Apart from the visitor, an observer is present.

    Behavioral: Dog visit

  • Experimental
    2: Dog visit with an additional activity (DA)

    The nursing home resident receives 12 10-minute visits in their own room. The visitor is accompanied with a dog, and the resident can touch the dog. During the visit, the visitor offers the resident to participate in an activity that involves interacting with the dog. Apart from the visitor, an observer is present.

    Behavioral: Dog visit · Behavioral: Encourage to engage in activity

  • Active comparator
    3: Visit without dog, with an additional activity (A)

    The nursing home resident receives 12 10-minute visits in their own room. During the visit, the visitor offers the resident to participate in an activity. Apart from the visitor, an observer is present, but no dog is present..

    Behavioral: Encourage to engage in activity

Interventions

  • BehavioralDog visit

    An visitor visits the participant with a dog

  • BehavioralEncourage to engage in activity

    In each visit the visitor invites the participant to engage in an activitty

06

What researchers measure

Primary outcomes

  1. Behavioural response during visits

    The behaviour of the residents is recorded by direct observation using continuous recording. In all visits, the frequency and duration of talk and physical contact to the persons present are recorded. Talk is classified into talk about the dog and/or activity, depending on the visit type. In visits with dogs (D, DA), the frequency and duration of physical contact and talk directed to the dog are recorded, and in visits involving an activity (DA, A), the frequency and duration of the residents' involvement in the activity are recorded.

    Time frame: Behaviour is recorded in all of the 12 visits in the 6 week intervention period

Secondary outcomes

  1. Cognitive impairment level, before intervention

    All participants were scored on the Mini-Mental State Examination (MMSE), which gives information about the participants' cognitive status.The MMSE score has a minimum and maximum value of 0 and 30, respectively. The lower the score, the more severe the cognitively impairment level.

    Time frame: This measure is obtained in the week preceeding the intervention period (6 weeks, 2 visits )

  2. Daily function level, before intervention

    All participants were scored on The Gottfries-Bråne-Steen Scale (GBS), which is an evaluation of disabilities, language, psychiatric symptoms, average daily living function, and behaviour of the participants. The GBS score has a minimum and maximum value of 0 and 156, respectively. The lower the score, the more well-functioning the patient.

    Time frame: This measure is obtained in the week preceeding the intervention period (6 weeks, 2 visits )

  3. Symptoms of depression, before intervention

    All participants were scored on the Geriatric Depression Scale (GDS), to screen for symptoms of depression. The GDS score has a minimum and maximum value of 0 and 15, respectively.A high score indicates more symptoms of depression.

    Time frame: This measure is obtained in the week preceeding the intervention period (6 weeks, 2 visits )

  4. Cognitive impairment level, after intervention

    All participants were scored on the Mini-Mental State Examination (MMSE), which gives information about the participants' cognitive status. The MMSE score has a minimum and maximum value of 0 and 30, respectively. The lower the score, the more severe the cognitively impairment level.

    Time frame: This measure is obtained in the week following the intervention period (6 weeks, 2 visits )

  5. Daily function level,, after intervention

    All participants were scored on The Gottfries-Bråne-Steen Scale (GBS), which is an evaluation of disabilities, language, psychiatric symptoms, average daily living function, and behaviour of the participants. The GBS score has a minimum and maximum value of 0 and 156, respectively. The lower the score, the more well-functioning the patient.

    Time frame: This measure is obtained in the week following the intervention period (6 weeks, 2 visits )

  6. Symptoms of depression, after intervention

    All participants were scored on the Geriatric Depression Scale (GDS), to screen for symptoms of depression. The GDS score has a minimum and maximum value of 0 and 15, respectively.A high score indicates more symptoms of depression.

    Time frame: This measure is obtained in the week following the intervention period (6 weeks, 2 visits )

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04635124
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
Nov 18, 2020
Start date
Jan 1, 2015
Primary completion
Nov 1, 2017
Completion
Nov 1, 2017
Last update
Nov 18, 2020

Study contacts

Karen Thodberg
principal investigator · University of Aarhus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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