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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03946696
Other study ID # 2-097-18
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 15, 2021
Est. completion date July 14, 2023

Study information

Verified date February 2021
Source University of Aberdeen
Contact Cristina R Douglas
Phone +441224272726
Email r01crd17@abdn.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is a qualitative anthropological research that explores the effects of Animal-Assisted Therapy (AAT) for people with moderate and severe dementia living in a care facility. In particular, the study explores the effects that AAT can have on people with moderate and later stages of dementia, living in a care facility, on: Behavioural and Psychological Symptoms of Dementia (BPSD); mood (depression); quality of life; activity (physical). The AAT effects on people with moderate and later stages of dementia will be compared with effects that other activities provided in the care facility where participants live, may have on the same participants. This study does not test hypotheses.


Description:

This study is a qualitative anthropological research that explores the effects of Animal-Assisted Therapy (AAT) for people with moderate and severe dementia living in a care facility. In particular, the study explores the effects that AAT can have on people with moderate and later stages of dementia, living in a care facility, on: Behavioural and Psychological Symptoms of Dementia (BPSD); mood (depression); quality of life; activity (physical). The AAT effects on people with moderate and later stages of dementia will be compared with effects that other activities provided in the care facility where participants live, may have on the same participants. AAT is defined as an activity provided by a handler and his/her animal (e.g., dog, cat, rabbit, bird, horse) for somebody living with a certain medical condition/illness. AAT is different than Assistant Dogs/Animal (e.g., guide dogs for the blind), who have a very specific training. In this research, we will focus mostly on therapy-dogs and therapy-owls for people with dementia living in care homes. The research will be conducted over a period of 12 months. The primary methods that will be used are participant observation (accompanying and observing volunteers during animal-assisted therapy meetings and various activities in the care homes) and interviewing the residents, care homes' staff, volunteers, canine trainers and veterinarians. Additional data will be collected through document analysis (consulting care home policies and participants' care plans and medical notes) and auto-ethnography (auto-observations of interactions between the student and 2 dogs). The instruments described in the outcome measures are used as guidance only. As this research is non-quantitative, the items listed in the scale instruments are not administered like in a usual clinical testing. The specificity of anthropological research, especially in regard to the use of its methods (participant observation, triangulated with in-depth interview, document analysis and auto-ethnography) addresses implicitly the limitations of such instruments. While the focus of the research remains on the interactions between people with dementia and therapy-animals, the involvement of the other participants offers different perspectives of looking at these interactions and at their context. For anthropological research, it is fundamental that a certain topic/issue is addressed in its context by gathering information from multiple perspectives. This has been documented as being one of the biggest strengths of anthropological research investigating a clinical-related topic. The aim of this research is to understand what are the effects that therapy-animals can have on people living with dementia (in moderate and severe stages) in a care facility. While it doesn't aim to compare people living with dementia in their own homes and their potential interaction with a therapy-animal, the research compares the effects of AAT with other activities (e.g., music therapy; craft therapy) and in the context of human interactions (e.g., interactions with other residents; care facility staff members; family members). Because it is documented that animals' therapeutic effects are possible through bond transference, the research also looks as part of the context at how the human-animal bond is formed, how can be transferred and how participants may develop a bond with the therapy-animal. This will be done by interviewing therapy-animal volunteers; canine trainers; and veterinarians. While these might appear as two different projects, we argue that this perspective (how the human-animal bond is formed and its potential therapeutic effect in being transferred) can offer new and original insights in understanding dementia and its stages, as well as a more accurate understanding of AAT effects on people with moderate and severe dementia. Although the benefits of Animal-Assisted Therapy have been previously documented, these were mostly statistical or experimental studies. To date, there is no study that explores the relationship between therapy-animals and people with dementia using a long-term qualitative approach. Almost all the studies consulted in preparation for our protocol recommend a research that approaches AAT for people with dementia in the context of social interactions and living conditions and from the perspectives described by us. The lack of the context and of these perspectives have been documented/acknowledged as limitations of previous studies in understanding the effects of AAT for people with dementia. These limitations are addressed in our study by looking at them from the diversity of the perspectives we propose. Given the increased number of people living with dementia, the moral imperative of offering them activities that enhance their quality of life especially in later stages, as well as the rising literature documenting the benefits of companion animals, we aim that this research to contribute to new approaches and policies of care for people with moderate and severe dementia.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date July 14, 2023
Est. primary completion date July 14, 2022
Accepts healthy volunteers
Gender All
Age group 55 Years to 100 Years
Eligibility Inclusion Criteria: 1. People diagnosed with moderate and severe dementia living in a nursing home, age range 55-100. 2. The above-mentioned participants who receive therapy-animal services. Exclusion Criteria: 1. People with other medical conditions who receive visits from therapy-animals and who do not reside in a care home. 2. People with dementia who do not reside in a care home. 3. People with dementia younger than 55 years old who live in their own home.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Interactions with therapy-animals
How people interact with humans and non-humans animals during and outside visits from therapy-animal teams.

Locations

Country Name City State
United Kingdom University of Aberdeen Aberdeen Aberdeenshire

Sponsors (1)

Lead Sponsor Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Behavioural and Psychological Symptoms of Dementia (BPSD) Observations of behaviours associated with dementia (wandering; agitation; anxiety; irritability; apathy; disinhibition). Please note this is a qualitative study that does not use measuring tools. 12 months
Primary Symptoms of Depression in dementia Observation - Please note this is a qualitative study that does not use measuring tools. 12 months
Primary Verbal and non-verbal aspects of communication in dementia (e.g., smile; touch; direction of gaze); words. Observations and interviews - Please note this is a qualitative study that does not use measuring tools. 12 months
Secondary Patient experience of Animal-Assisted Therapy visits Qualitative evaluation of patient experience of visits from a therapy-animal team assessed in qualitative in-depth interviews. 15 minutes-1 hour
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