Alzheimer Disease Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Cumming School of Medicine, University of Calgary | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Alzheimer's Association |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Depressive Symptoms | Depressive symptoms which will be measured using Cornell Scale for Depression in Dementia. This scale assesses signs and symptoms of major depression in PLWD via a caregiver reported proxy. There are 19 items on the scale, each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). Scores above 10 indicate a probable major depression. Scores above 18 indicate a definite major depression. Scores below 6 are associated with absence of significant depressive symptoms. The CSDD total score will be used to assess change in depressive symptoms. | Change from Baseline Depressive symptoms at 4 weeks (mid-intervention) and at 8 weeks (post-intervention) | |
Secondary | Cognition | Cognition which will be measured using the Repeatable Battery for Assessment of Neuropsychological Syndromes (RBANS). This is a brief, individually administered test to measure the rate of cognitive decline or improvement. This assessment consists of 12 subtests, which yield five Index scores and a total Scale score. The scores are classified based on the following: average/mild impairment (standard scores of 70 or above), moderate impairment (standard scores from 55 to 69), and severe impairment (standard scores <54)). The RBANS total score will be used to measure change in cognition. | Change from Baseline Cognition at 4 weeks (mid-intervention) and at 8 weeks (post-intervention) | |
Secondary | Quality of Life assessed by DEMQoL (Dementia Quality of Life assessment) | Quality of life will be assessed using the dementia quality of life assessment.These are interviewer-administered measures which obtain self- and caregiver reports of the health-related quality of life for people with dementia. Items inquire about 'feelings', 'memory' and 'everyday life' of the person with dementia in the last week. Each question is assessed on a 4-point scale (a lot, quite a bit, a little, not at all). The items are scored according to a standard scoring to produce an overall score where higher scores represent better health-related quality of life. The DEMQoL total score ranges from 28 to 112. | Change from Baseline Health-related quality of life at 4 weeks (mid-intervention) and at 8 weeks (post-intervention) | |
Secondary | Caregiver Burden | Caregiver burden will be assessed using the Zarit Burden Interview scale. This consists of 22 items, each item on the interview is a statement which the caregiver is asked to endorse using a 5-point Likert scale (0=never, 1=rarely, 2=sometimes, 3=quite frequently, 4=nearly always). The sum of scores range between 0-88 (0 - 21 little or no burden; 21 - 40 mild to moderate burden; 41 - 60 moderate to severe burden; 61 - 88 severe burden). | Change from Baseline Caregiver Burden at 4 weeks (mid-intervention) and at 8 weeks (post-intervention) | |
Secondary | Caregiver Well-being and Support | Caregiver well-being and support will be measured using the carer well-being and support questionnaire. This questionnaire contains two subscales: wellbeing and support. Higher well-being scale total (range: 0-128) indicates better carer wellbeing; while higher support scores (reverse scoring used and total range: 0-51) indicates lower satisfaction with support received. | Change from Baseline Caregiver well-being and support at 4 weeks (mid-intervention) and at 8 weeks (post-intervention) | |
Secondary | Neuropsychiatric Symptoms | The Neuropsychiatric Inventory Questionnaire (NPI-Q) measured at week 4 will be included as a secondary outcome and the NPI-Q properties are described in the primary outcome section of the protocol. | Change from Baseline to week 4 on the NPI-Q total score. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04079803 -
PTI-125 for Mild-to-moderate Alzheimer's Disease Patients
|
Phase 2 | |
Completed |
NCT04044495 -
Sleep, Rhythms and Risk of Alzheimer's Disease
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Recruiting |
NCT04520698 -
Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease
|
N/A | |
Active, not recruiting |
NCT04606420 -
Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease
|
N/A | |
Recruiting |
NCT05820919 -
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
|
N/A | |
Terminated |
NCT03672474 -
REGEnLIFE RGn530 - Feasibility Pilot
|
N/A | |
Completed |
NCT03430648 -
Is Tau Protein Linked to Mobility Function?
|
||
Recruiting |
NCT05288842 -
Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
|
||
Recruiting |
NCT05557409 -
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
|
Phase 3 | |
Recruiting |
NCT04522739 -
Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease
|
Phase 4 | |
Recruiting |
NCT04949750 -
Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
|
N/A | |
Completed |
NCT06194552 -
A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07
|
Phase 1 | |
Completed |
NCT03239561 -
Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants
|
Early Phase 1 | |
Completed |
NCT03184467 -
Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Terminated |
NCT03487380 -
Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Recruiting |
NCT05328115 -
A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease
|
Phase 1 | |
Completed |
NCT05562583 -
SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
|
N/A |