The Effects of a Park Visit Program on Individuals With Dementia and Their Caregivers

NCT05527587 | Unknown

• 1 other identifier: REB22-0788
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Dementia; Moderate Dementia; Alzheimer Disease

Keywords

Dementia; Nature; Outdoor activities; Mental health; Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• Neuropsychiatric Symptoms

  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)

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

Secondary Outcomes (6)

• Depressive Symptoms

  Change from Baseline Depressive symptoms 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)

• 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)

• Caregiver Burden

  Change from Baseline Caregiver Burden at 4 weeks (mid-intervention) and at 8 weeks (post-intervention)

• Caregiver Well-being and Support

  Change from Baseline Caregiver well-being and support at 4 weeks (mid-intervention) and at 8 weeks (post-intervention)

Study Arms (1)

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.

Other: Nature Connections Intervention

Interventions

Nature Connections Intervention OTHER

10 PLWD and their 10 caregivers will be examined for the effects of a park visit program on their behaviour and mood symptoms, cognition, and quality of life over the period of 8-weeks. If participants meet the study criteria, an initial education session on the health benefits of nature will be provided to the them. Participants will then be invited to participate in the park visit program which will have them visiting local parks or outdoors spaces with their caregivers. They will be encouraged to allocate approximately 120 minutes each week to outdoor park activities for 8 weeks. Participants will be provided with a visit passport to record a log of activities completed during the park visits. During the 8 weeks of intervention, participants will also participate in a weekly check-in meeting with other participants to discuss about their experiences with the park visits.

Also known as: Park Visit Program, Nature-based Activities

Nature Connections Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Alzheimer's Association: collaborator

Study Sites (1)

Cumming School of Medicine, University of Calgary

Calgary, Alberta, T2N1N4, Canada

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Psychological Well-Being

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Dallas P Seitz, MD, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dallas P Seitz, MD, PhD

CONTACT

4032106867; dallas.seitz@ucalgary.ca

Margaret O Abolarin, BSc

CONTACT

5878897805; margaret.abolarin@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: September 2, 2022
• Study Start: November 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 9, 2024

Record last verified: 2023-08

Locations

CA (1)