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Clinical Trials/NCT05527587
NCT05527587UnknownNot Applicable

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

University of Calgary1 site in 1 country20 target enrollmentStarted: November 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Locations
1
Primary Endpoint
Neuropsychiatric Symptoms

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Masking Description

Since we have limited evidence on the effects of non-pharmacological treatment for dementia including nature-based activities, we would like to perform an open-label pilot study to understand the effects of nature-based activities in people living with dementia in preparation for a future controlled trial.

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Nature Connections Group

Experimental

Participants will be screened to confirm their eligibility to partake in the study. Participants who meet the study criteria will then be invited to participate in the nature connections intervention. At the start of the intervention, mid-intervention and post intervention, participants will be invited to participate in assessments of their behaviour and mood symptoms, cognition, quality of life, caregiver burden and stress levels using different measures and questionnaires at the University of Calgary. Participants will be provided with a visit passport to record a log of activities completed during the park visits.

Intervention: Nature Connections Intervention (Other)

Outcomes

Primary Outcomes

Neuropsychiatric Symptoms

Time Frame: Change from Baseline Neuropsychiatric Symptoms at 8 weeks (post-intervention)

The primary measure of neuropsychiatric symptoms is mood and behavior measured at week 8 as measured on the Neuropsychiatric Inventory Questionnaire (NPI-Q) total score. This questionnaire measures severity of the symptoms in individuals on a 3-point scale (1=mild; 2=moderate; and 3=severe) and the distress associated with the symptoms on a 5-point scale (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=extreme distress). The scores range from 0 (absence of behavioral symptoms) to 144 points (maximum severity of behavioral symptoms)

Secondary Outcomes

  • Caregiver Well-being and Support(Change from Baseline Caregiver well-being and support at 4 weeks (mid-intervention) and at 8 weeks (post-intervention))
  • Depressive Symptoms(Change from Baseline Depressive symptoms at 4 weeks (mid-intervention) and at 8 weeks (post-intervention))
  • Quality of Life assessed by DEMQoL (Dementia Quality of Life assessment)(Change from Baseline Health-related quality of life at 4 weeks (mid-intervention) and at 8 weeks (post-intervention))
  • Cognition(Change from Baseline Cognition at 4 weeks (mid-intervention) and at 8 weeks (post-intervention))
  • Caregiver Burden(Change from Baseline Caregiver Burden at 4 weeks (mid-intervention) and at 8 weeks (post-intervention))
  • Neuropsychiatric Symptoms(Change from Baseline to week 4 on the NPI-Q total score.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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