DementiaNCT04635124
Optimal Dog Visits
A study testing Dog visit and Encourage to engage in activity in people with Dementia and Aging, run by University of Aarhus.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- What is being tested?
- Dog visit and Encourage to engage in activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being able to sit up during the visits
Who cannot join
- Dog allergy
- Fear of dogs
- Health problems that make participation unadvisable
About this study
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.
- Being tested
- Dog visit, Encourage to engage in activity
- Keywords
- Animal-assisted therapy, visiting dog, non-pharmacological, nursing home
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dog visitBehavioural
An visitor visits the participant with a dog
Encourage to engage in activityBehavioural
In each visit the visitor invites the participant to engage in an activitty
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Dog visit; Behavioral: 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.. Receives: Behavioral: Encourage to engage in activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Behaviour is recorded in all of the 12 visits in the 6 week intervention period
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: This measure is obtained in the week following the intervention period (6 weeks, 2 visits )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Jan 2015
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.).
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Thodberg, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635124
- Sponsor's protocol ID
- Optimal dog visits
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Dog Visits
- ClinicalTrials.gov ID
- NCT04635124
- Acronym / sponsor ID
- Optimal dog visits
- Keywords
- Animal-assisted therapy, visiting dog, non-pharmacological, nursing home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.).
| Arm | Type | Receives |
|---|---|---|
| 1: Dog visit with a dog, no additional activity (D) | Active comparator | Behavioral: Dog visitThe 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. |
| 2: Dog visit with an additional activity (DA) | Experimental | Behavioral: Dog visit, Behavioral: Encourage to engage in activityThe 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. |
| 3: Visit without dog, with an additional activity (A) | Active comparator | Behavioral: Encourage to engage in activityThe 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.. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being able to sit up during the visits
Key exclusion criteria (3 listed)
- Dog allergy
- Fear of dogs
- Health problems that make participation unadvisable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dog visitAn visitor visits the participant with a dog | Behavioural | 1: Dog visit with a dog, no additional activity (D), 2: Dog visit with an additional activity (DA) |
| Encourage to engage in activityIn each visit the visitor invites the participant to engage in an activitty | Behavioural | 2: Dog visit with an additional activity (DA), 3: Visit without dog, with an additional activity (A) |
Primary outcome
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.
6 secondary outcomes
Cognitive impairment level, before intervention
Time frame: 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 )
Symptoms of depression, before intervention
Time frame: 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 )
Daily function level,, after intervention
Time frame: 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 )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Thodberg principal investigator
University of Aarhus
Questions about this trial
What is this clinical trial studying?
A study testing Dog visit and Encourage to engage in activity in people with Dementia and Aging, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioural response during visits (time frame: Behaviour is recorded in all of the 12 visits in the 6 week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.