Optimal Dog Visits

November 17, 2020 updated by: University of Aarhus

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
186

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Behavioural response during visits
Time Frame: Behaviour is recorded in all of the 12 visits in the 6 week intervention period
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cognitive impairment level, before intervention
Time Frame: This measure is obtained in the week preceeding the intervention period (6 weeks, 2 visits )
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
Time Frame: This measure is obtained in the week preceeding the intervention period (6 weeks, 2 visits )
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
Time Frame: This measure is obtained in the week preceeding the intervention period (6 weeks, 2 visits )
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
Time Frame: This measure is obtained in the week following the intervention period (6 weeks, 2 visits )
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
Time Frame: This measure is obtained in the week following the intervention period (6 weeks, 2 visits )
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
Time Frame: This measure is obtained in the week following the intervention period (6 weeks, 2 visits )
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karen Thodberg, University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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