Clinical trial NCT05527587: The Effects of a Park Visit Program on Individuals With Dementia and Their Caregivers
Official title: Examining the Effects of an 8-Week Open Label Nature-Based Park Visit Program on the Quality of Life, Behaviors and Cognitive Symptoms of Individuals With Dementia and Their Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Dementia
Moderate Dementia
Alzheimer Disease
Keywords: Dementia
Nature
Outdoor activities
Mental health
Alzheimer's disease
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
First posted: 2022-09-02
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall goals of our project is to understand the effects of participating in park visits and nature-based activities for people living with dementia and their caregivers. Nature-based activities such as park visits can have beneficial effects on quality of life, psychological symptoms and physical health. However, there may be barriers for people with dementia and their caregivers that may prevent them from engaging in park visits. The Nature Connections park visit program will provide education sessions for 10 persons living with dementia and 10 caregivers highlighting the beneficial effects of park visits and address common barriers to participating in park visits. Following the education session participants will be provided with weekly telephone/internet support meetings for participants to share their experiences with park visits and to address any challenges individuals encountered when trying to complete their visits. The impact of park visits on quality of life, behaviours, and measures of stress for people with dementia and their caregivers will be assessed over 8 weeks. Following completion of the program participants will provide an evaluation of the program to understand their experience and satisfaction with the program. This project will provide new information about the effects of park visits as a practical strategy to improve the quality of life, psychological symptoms and measures of stress for both people with dementia and caregivers.

Detailed description: Background \& Rationale:

Cognitive impairment has been the main focus in treating and caring for people living with dementia (PLWD). More recently, non-cognitive symptoms associated with dementia are increasing and forcing families to seek non-pharmacological treatment approaches for dementia related symptoms. Previous studies has also shown the effect of aerobic exercises and other non-pharmacological interventions in providing a range of benefit such as physical, mental, and emotional benefit in people without dementia, however, there is limited evidence on the effect of nature-based activities on PLWD. Many PLWD are disconnected from the outdoors due to a significant amount of time spent indoors resulting in reduced knowledge about how nature-based activities can benefit the QoL of PLWD. The specific aim of this project is to evaluate the effect of parks visit, an example of nature-based activities on the neuropsychiatric symptoms, QoL, cognition, stress and burden of PLWD and their caregivers.

Objectives:

1) The objective of this project is to investigate the impact of a 8-week nature park visit program intervention on stress, quality of life and cognition in 10 pairs of PLWD and their caregivers; 2) Evaluate the impact of potential barriers on participation in activity and their influence on the QoL of PLWD.

Methods:

10 pairs of PLWD and their caregivers who live in the community will be recruited into the nature connections intervention program. This study will be an open-label pilot study using pre-post design. The nature connections intervention will include an 8-week park visit program after which PLWD and their caregivers will be assessed on factors including changes in cognitive function, changes in mood and behaviors, changes in QoL, and changes in stress levels. These factors will be assessed in participants at baseline, week 4 (mid-intervention) and week 8 (post-intervention) to appropriately evaluate the impact of the intervention. Screening measures including demographics, cognition, physical activity, and functional ability will be assessed and collected during the screening period to meet the inclusion criteria for the study. Behavior and mood symptoms will be assessed using the Neuropsychiatric Inventory-Questionnaire (NPI-Q while depressive symptoms will be assessed using the Cornell Scale for Depression in Dementia (CSDD). Cognition will be measured using the Repeatable Battery for Assessment of Neuropsychological Syndromes (RBANS). Changes in Quality of life will be assessed using the Dementia Quality of Life (DEMQOL) assessment. The activity log of park visits will be recorded from baseline until week 8. Caregiver specific outcomes, caregiver burden and caregiver well-being and support will be assessed at baseline, week 4 during intervention and week 8 post intervention. Caregiver burden will be assessed using the Zarit Burden Interview (ZBI) while caregiver well-being and support will be measured using the Carer Well-being and Support questionnaire. The intervention will also include weekly check-in meetings where participants can discuss their experience with the park visits with other participants.

Data Analysis:

The primary outcome for PLWD is change in neuropsychiatric symptoms as measured from baseline to week week 8 on the NPI-Q using paired t-tests. Secondary outcomes include measurement of depressive symptoms (CSDD), cognition (RBANS), quality of life, care giver stress and caregiver burden (ZBI) at weeks 4 and week 8 of the study. Two-sided p-values of \<0.05 will be used as the threshold for statistical significance.

Eligibility criteria: Inclusion Criteria:

* Male and female participants who are 65 years or older
* PLWD who meet Diagnostics and Statistical Manual of Mental Disorders DSM-5 for major neurocognitive disorder due to Alzheimer's disease
* Individuals with mild to moderate dementia as assessed on the Montreal Cognitive Assessment (MoCA) corresponding to scores of 12-25 on the 12-item assessment or 10-18 on the 9-item telephone MoCA assessment
* Participants who currently participate in less than 2 hours of outdoor activities weekly using the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire
* Caregivers who spend at least 2 hours per week with PLWD
* Participants that are able to mobilize independently or with assistive devices and have the ability access local parks either independently or with the assistance of caregivers.

Exclusion Criteria:

* Participants with unstable conditions that prevent outdoor activities
* Patients residing in long-term care or nursing homes
* Individuals with AD who have no access to a caregiver
* Participants with limited mobility that prevents outdoor activities
* Participants who do not have adequate comprehension and verbal communication in English necessary to participate in measurement of outcomes.

Primary outcomes:
measure: Neuropsychiatric Symptoms
timeFrame: Change from Baseline Neuropsychiatric Symptoms at 8 weeks (post-intervention)
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: Change from Baseline Depressive symptoms at 4 weeks (mid-intervention) and at 8 weeks (post-intervention)
measure: Cognition
timeFrame: Change from Baseline Cognition at 4 weeks (mid-intervention) and at 8 weeks (post-intervention)
measure: Quality of Life assessed by DEMQoL (Dementia Quality of Life assessment)
timeFrame: Change from Baseline Health-related quality of life at 4 weeks (mid-intervention) and at 8 weeks (post-intervention)
measure: Caregiver Burden
timeFrame: Change from Baseline Caregiver Burden at 4 weeks (mid-intervention) and at 8 weeks (post-intervention)
measure: Caregiver Well-being and Support
timeFrame: Change from Baseline Caregiver well-being and support at 4 weeks (mid-intervention) and at 8 weeks (post-intervention)
measure: Neuropsychiatric Symptoms
timeFrame: Change from Baseline to week 4 on the NPI-Q total score.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Cumming School of Medicine, University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Dallas P Seitz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: