NCT04635124

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

2.8 years

First QC Date

November 16, 2020

Last Update Submit

November 17, 2020

Conditions

Keywords

Animal-assisted therapyvisiting dognon-pharmacologicalnursing home

Outcome Measures

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.

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

Secondary Outcomes (6)

  • Cognitive impairment level, before intervention

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

  • Daily function level, before intervention

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

  • Symptoms of depression, before intervention

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

  • Cognitive impairment level, after intervention

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

  • Daily function level,, after intervention

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

  • +1 more secondary outcomes

Study Arms (3)

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

ACTIVE COMPARATOR

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

2: Dog visit with an additional activity (DA)

EXPERIMENTAL

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 visitBehavioral: Encourage to engage in activity

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

ACTIVE COMPARATOR

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

Dog visitBEHAVIORAL

An visitor visits the participant with a dog

1: Dog visit with a dog, no additional activity (D)2: Dog visit with an additional activity (DA)

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

2: Dog visit with an additional activity (DA)3: Visit without dog, with an additional activity (A)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being able to sit up during the visits

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dementia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Karen Thodberg

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The design of the study is a stratified and randomized complete block design. Each nursing home is a block. The participants are allocated randomly to one of the three visit types (1) Visits with a dog, no activity (D); 2) Visits with a dog, with activity (DA); or 3) Visits without dog, with an activity (A), balancing for the level of cognitive impairment, measured by the MMSE-scale. This was achieved by ranking the participants according to MMSE score within sex and allocating them to the three visit types by using different numerical orders in each nursing home (1, 2, 3; 3, 1, 2; 2, 3, 1 etc.).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 18, 2020

Study Start

January 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

November 18, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share