A Feasiblity Study of Green Activity Program for People Living With Memory Challenges

Not Applicable

Recruiting

• Conditions: Mild Cognitive Impairment; Alzheimer Disease; Subjective Cognitive Decline (SCD)
• Interventions: Behavioral: Green Activity Program

• Registration Number: NCT06403345
• Lead Sponsor: Indiana University

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.

Study Timeline

• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-05-03
• Study First Posted: 2024-05-07
• Study Start: 2024-07-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm pre/post study	Green Activity Program	GAP-H 12-week Intervention for People Living with Memory Loss \& Study Partners involves an OT evaluation, goal-setting, coaching and strategy training over 4-8 in-person sessions for 30-90 minutes each over 12 weeks, with 2 phone or virtual check-ins for 15-30 minutes. GAP-H Intervention Outdoor Activity Professionals involves a site-evaluation (Accessibility, Fall risk) and education on Dementia Training, SMART Goal setting, Strategy Training for Tailoring Nature Activities, and Behavioral Activation strategies with support from the OT.

Primary Outcome Measures

Name	Time	Method
Feasibility intervention completion rate	Through study completion	intervention completion rate of 75%
Other Feasibility measures	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.
Acceptability	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).

Secondary Outcome Measures

Name	Time	Method
Sedentary time	1 week pre 12-week program and 1 week post	ActiGraph LEAP
Goal Attainment Scaling	Up to one month after the 12-week program	Primary goal met (yes/no)
Heart Rate	1 week pre 12-week program and 1 week post	ActiGraph LEAP
Quick Physical Activity Scale	Up to 1 month before and after the 12-week program	Physical activity
Neuropsychiatric symptoms	Up to 1 month before and after the 12-week program	Neuropsychiatric symptoms questionnaire
Brief phone interviews	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?"
Study Partner Health	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.
Study Partner well-being	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.
Study Partner Depression	Up to 1 month before and after the 12-week program	Geriatric Depression Scale short form
Acceptability for Study Partner	Up to 1 month after the program	Acceptability of an Intervention Measure
Physical activity	1 week pre 12-week program and 1 week post	ActiGraph LEAP
Sleep	1 week before and 1 week after the 12 week intervention	ActiGraph LEAP
Health	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.
Well-being	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.
Social Participation	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.
Depression	Up to 1 month before and after the 12-week program	Geriatric Depression Scale short form,
Behavioral Activation	Up to 1 month before and after the 12-week program	Behavioral Activation Scale Short Form
UCLA 3-item Loneliness scale	Up to 1 month before and after the 12-week program	Loneliness
Study Partner Social Participation	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.
Feasibility for Study partner	Up to 1 month after the 12-week program	Feasibility of an Intervention Measure
Outdoor Professional strategies for tailoring activities	Up to 1 month before and after the strategy training	Strategies for Tailoring Activities quiz
Outdoor Professional brief phone interview	Up to 2 weeks after the 12 week program	15-minute brief phone interview post
Brief phone interview	Up to 1 month after the 12-week program	"What did you like about the program? What would you change?"
Outdoor Professional Dementia Knowledge	Up to 1 month before and after the dementia training	Dementia Knowledge Assessment
Usability	up to 2 weeks after baseline testing with the ActiGraph LEAP and CenterePointe App software	Holden's Simplified Systems Usability Scale (SSUS)
Appropriateness for Study Partner	Up to 1 month after the 12-week program	Appropriateness of an Intervention Measure
Sustained Behavior Change for People Living with Memory Challenges	1 month after the 12 week program	3 Questions asked via phone; 1. Are you still doing the activities?; 2. (If yes) Do you plan to continue doing the activities? (If no) Why not? Do plan to do them in the future?; 3. Have you added any new activities?
Cognitive function	Up to 1 month before and after 12 week program	T-MoCa

Trial Locations

Locations (1)

Indiana University Bloomington; 🇺🇸 Bloomington, Indiana, United States