Indiana University Bloomington
Bloomington, Indiana, 47401, United States
Location status: Recruiting
Location contact
Rebecca Lassell, PhD
CONTACT
NCT Number: NCT06403345
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.
Interested in participating?
Request Info45 year and older
All sexes
Interventional
Not applicable
Bloomington, Indiana, 47401, United States
Location status: Recruiting
Rebecca Lassell, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Study partner
Outdoor activity professionals
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+) :
See arm description.
Time frame: Through study completion
intervention completion rate of 75%
Time frame: Through study completion
75% attendance, 75% retention, intervention fidelity using a checklist by an outside rater with at least 75% of potential active ingredients present in 25% of randomly sampled sessions: tailoring (environment, activity, personalized delivery), behavioral activation, and nature (outdoor environment or incorporating nature [plant or animal]). Feasibility data of recruitment rates (eligible participants/# recruited per month), feasibility of assessments (time to complete, with an 80% completion rate) will be collected, and we will also track missing data.
Time frame: Up to one month after the 12-week program.
Two selected questions from the Intervention Tolerability scale will be asked to the person living with memory challenges over the phone: "The program was easy to use" and "I liked this program." Rated by (yes/no). We expect at least 70% of people living with memory challenges will be satisfied with the intervention (yes to both questions).
Time frame: Up to one month after the 12-week program
Primary goal met (yes/no)
Time frame: Up to 1 month before and after the 12-week program
Physical activity
Time frame: 1 week pre 12-week program and 1 week post
ActiGraph LEAP
Time frame: 1 week pre 12-week program and 1 week post
ActiGraph LEAP
Time frame: 1 week pre 12-week program and 1 week post
ActiGraph LEAP
Time frame: Up to 1 month before and after the 12-week program
Patient-Reported Outcomes Measurement Information System: Physical health. Scored on the T-score metric. High scores mean more of the concept being measured.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
Time frame: Up to 1 month before and after the 12-week program
Patient-Reported Outcomes Measurement Information System: Mental Health. Scored on the T-score metric. High scores mean more of the concept being measured.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
Time frame: Up to 1 month before and after the 12-week program
Patient-Reported Outcomes Measurement Information System: Satisfaction with participation in social activities. Scored on the T-score metric. High scores mean more of the concept being measured.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
Time frame: Up to 1 month before and after the 12-week program
Geriatric Depression Scale short form,
Time frame: Up to 1 month before and after the 12-week program
Behavioral Activation Scale Short Form
Time frame: 1 week before and 1 week after the 12 week intervention
ActiGraph LEAP
Time frame: Up to 1 month before and after the 12-week program
Loneliness
Time frame: Up to 1 month before and after the 12-week program
Neuropsychiatric symptoms questionnaire
Time frame: Up to 1 month after the 12-week program
2 -Post questions over the phone: "What did you like about the program? What would you change?"
Time frame: Up to 1 month before and after the 12-week program
Patient-Reported Outcomes Measurement Information System: Physical health. Scored on the T-score metric. High scores mean more of the concept being measured.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
Time frame: Up to 1 month before and after the 12-week program
Patient-Reported Outcomes Measurement Information System: Mental Health. Scored on the T-score metric. High scores mean more of the concept being measured.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
Time frame: Up to 1 month before and after the 12-week program
Patient-Reported Outcomes Measurement Information System: Satisfaction with participation in social activities. Scored on the T-score metric. High scores mean more of the concept being measured.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
Time frame: Up to 1 month before and after the 12-week program
Geriatric Depression Scale short form
Time frame: Up to 1 month after the 12-week program
Feasibility of an Intervention Measure
Time frame: Up to 1 month after the program
Acceptability of an Intervention Measure
Time frame: Up to 1 month after the 12-week program
Appropriateness of an Intervention Measure
Time frame: Up to 1 month after the 12-week program
"What did you like about the program? What would you change?"
Time frame: Up to 1 month before and after the dementia training
Dementia Knowledge Assessment
Time frame: Up to 1 month before and after the strategy training
Strategies for Tailoring Activities quiz
Time frame: Up to 2 weeks after the 12 week program
15-minute brief phone interview post
Time frame: 1 month after the 12 week program
3 Questions asked via phone
Time frame: Up to 1 month before and after 12 week program
T-MoCa
Time frame: up to 2 weeks after baseline testing with the ActiGraph LEAP and CenterePointe App software
Holden's Simplified Systems Usability Scale (SSUS)
Contact information is provided by the study sponsor or research team.
Indiana University
Other
Acronym: GAP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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