Clinical trial NCT06403345: A Feasiblity Study of Green Activity Program for People Living With Memory Challenges
Official title: A Feasiblity Study of Green Activity Program for People Living With Memory Challenges
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Subjective Cognitive Decline (SCD)
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: American Federation for Aging Research
First posted: 2024-05-07
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test the Green Activity Program that was designed with people living with memory challenges and their study partners to see if it can be done and if they enjoy the program. "Green activities" are nature activities that the person enjoys and can be done with other people or pets. For example, dog walking, hiking, outdoor yoga, and gardening are all green activities. The purpose of the program is to help people living with memory challenges participate in nature activities they enjoy. The goal of the program is to help people stay active and improve their health and well-being.

Detailed description: This is a single arm pre/post feasibility study lasting up to 1 year. Investigators will recruit in n=40 dyads (people living with memory challenges and their study partners n=80 total) and expect n=30 (n=60 total people living with memory challenges and study partners) to complete the 12-week GAP and evaluate it for feasibility and acceptability. Anonymous program evaluation surveys will be administered either via paper or RedCap survey to the outdoor activity professionals who participated in the study. Brief recorded phone interviews (5 minutes) will be conducted with the people living with memory challenges and their study partners after the intervention and 15-minute brief calls with the outdoor activity professionals will be used to gather feedback to refine the program. Informal conversations with the occupational therapist(s) delivering the intervention will occur to identify areas for refinement and will be documented with anonymous notes and no identifiable data collected from them. Sustained behavior change will be measured in people living with memory challenges at 4 weeks after the intervention.

Eligibility criteria: Inclusion Criteria:

* 45 years or older
* Has memory challenges or difficulties thinking
* Have access and ability to respond to the telephone (mobile or landline)

Study partner

* 18 years or older
* Speaks Spanish or English
* Identified by the PLMC as a person they feel comfortable with who they would like to join them in the study. The study partner's participation is based on level of support needed for the PLMC.

Outdoor activity professionals

* 18 years or older
* at least 1 year experience providing outdoor activities

Exclusion Criteria:

* Participants living with memory challenges will be excluded if they do not meet inclusion criteria or if they indicate any of the following on the 2023 Physical Activity Readiness Questionnaire + (PAR-Q+)

  * Heart failure or difficulty controlling Coronary Artery Disease, Diagnosed Abnormality of Heart Rhythm, or other cardiovascular condition.
  * Cancer and are actively receiving therapies
  * Experienced a black out, fainted, or lost consciousness as a result of a head injury in the past 12 months.
  * Often experienced signs and symptoms of low blood sugar (hypoglycemia) following exercise and/or daily activities.
  * \>3 hospitalizations in the past year

Primary outcomes:
measure: Feasibility intervention completion rate
timeFrame: Through study completion
measure: Other Feasibility measures
timeFrame: Through study completion
measure: Acceptability
timeFrame: Up to one month after the 12-week program.
Secondary outcomes:
measure: Goal Attainment Scaling
timeFrame: Up to one month after the 12-week program
measure: Quick Physical Activity Scale
timeFrame: Up to 1 month before and after the 12-week program
measure: Heart Rate
timeFrame: 1 week pre 12-week program and 1 week post
measure: Physical activity
timeFrame: 1 week pre 12-week program and 1 week post
measure: Sedentary time
timeFrame: 1 week pre 12-week program and 1 week post
measure: Health
timeFrame: Up to 1 month before and after the 12-week program
measure: Well-being
timeFrame: Up to 1 month before and after the 12-week program
measure: Social Participation
timeFrame: Up to 1 month before and after the 12-week program
measure: Depression
timeFrame: Up to 1 month before and after the 12-week program
measure: Behavioral Activation
timeFrame: Up to 1 month before and after the 12-week program
measure: Sleep
timeFrame: 1 week before and 1 week after the 12 week intervention
measure: UCLA 3-item Loneliness scale
timeFrame: Up to 1 month before and after the 12-week program
measure: Neuropsychiatric symptoms
timeFrame: Up to 1 month before and after the 12-week program
measure: Brief phone interviews
timeFrame: Up to 1 month after the 12-week program
measure: Study Partner Health
timeFrame: Up to 1 month before and after the 12-week program
measure: Study Partner well-being
timeFrame: Up to 1 month before and after the 12-week program
measure: Study Partner Social Participation
timeFrame: Up to 1 month before and after the 12-week program
measure: Study Partner Depression
timeFrame: Up to 1 month before and after the 12-week program
measure: Feasibility for Study partner
timeFrame: Up to 1 month after the 12-week program
measure: Acceptability for Study Partner
timeFrame: Up to 1 month after the program
measure: Appropriateness for Study Partner
timeFrame: Up to 1 month after the 12-week program
measure: Brief phone interview
timeFrame: Up to 1 month after the 12-week program
measure: Outdoor Professional Dementia Knowledge
timeFrame: Up to 1 month before and after the dementia training
measure: Outdoor Professional strategies for tailoring activities
timeFrame: Up to 1 month before and after the strategy training
measure: Outdoor Professional brief phone interview
timeFrame: Up to 2 weeks after the 12 week program
measure: Sustained Behavior Change for People Living with Memory Challenges
timeFrame: 1 month after the 12 week program
measure: Cognitive function
timeFrame: Up to 1 month before and after 12 week program
measure: Usability
timeFrame: up to 2 weeks after baseline testing with the ActiGraph LEAP and CenterePointe App software
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University Bloomington
state: Indiana
Study officials:
affiliation: Indiana Unversity
name: Rebecca Lassell, PhD
role: PRINCIPAL_INVESTIGATOR
References: