Optimal Dog Visits

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Aging
• Intervention / Treatment: Behavioral: Dog visit; Behavioral: Encourage to engage in activity

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Being able to sit up during the visits

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; An visitor visits the participant with a dog
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; An visitor visits the participant with a dog; Behavioral: Encourage to engage in activity; In each visit the visitor invites the participant to engage in an activitty
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; In each visit the visitor invites the participant to engage in an activitty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This measure is obtained in the week preceeding the intervention period (6 weeks, 2 visits )
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.	This measure is obtained in the week preceeding the intervention period (6 weeks, 2 visits )
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.	This measure is obtained in the week preceeding the intervention period (6 weeks, 2 visits )
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.	This measure is obtained in the week following the intervention period (6 weeks, 2 visits )
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.	This measure is obtained in the week following the intervention period (6 weeks, 2 visits )
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.	This measure is obtained in the week following the intervention period (6 weeks, 2 visits )

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Karen Thodberg, University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: nursing home; non-pharmacological; Animal-assisted therapy; visiting dog
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: Optimal dog visits

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No