Clinical trial NCT04635124: Optimal Dog Visits
Official title: Optimal Dog Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Aging
Keywords: Animal-assisted therapy
visiting dog
non-pharmacological
nursing home
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 186
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.).
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

• Being able to sit up during the visits

Exclusion Criteria:

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

Primary outcomes:
measure: Behavioural response during visits
timeFrame: Behaviour is recorded in all of the 12 visits in the 6 week intervention period
Secondary outcomes:
measure: Cognitive impairment level, before intervention
timeFrame: This measure is obtained in the week preceeding the intervention period (6 weeks, 2 visits )
measure: Daily function level, before intervention
timeFrame: This measure is obtained in the week preceeding the intervention period (6 weeks, 2 visits )
measure: Symptoms of depression, before intervention
timeFrame: This measure is obtained in the week preceeding the intervention period (6 weeks, 2 visits )
measure: Cognitive impairment level, after intervention
timeFrame: This measure is obtained in the week following the intervention period (6 weeks, 2 visits )
measure: Daily function level,, after intervention
timeFrame: This measure is obtained in the week following the intervention period (6 weeks, 2 visits )
measure: Symptoms of depression, after intervention
timeFrame: This measure is obtained in the week following the intervention period (6 weeks, 2 visits )
Other outcomes:
Locations:
Study officials:
affiliation: University of Aarhus
name: Karen Thodberg
role: PRINCIPAL_INVESTIGATOR
References: