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

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease; Mild Cognitive Impairment; Subjective Cognitive Decline (SCD)
• Intervention / Treatment: Behavioral: Green Activity Program

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Lassell, PhD; Phone Number: 812-855-2395; Email: blassell@iu.edu
• Study Contact Backup: Name: Triana Pena; Email: tripena@iu.edu

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47401
      • Recruiting
      • Indiana University Bloomington
      • Contact: Rebecca Lassell, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

  • If they report difficulty controlling CAD, Diagnosed abnormality of heart rhythm they will be excluded.
  • If they endorse a diagnosis of heart failure, AND report symptoms greater than NYHA Functional Classification Stage I: "No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath," they will be excluded. Research assistants will be trained to ask about these symptoms during usual activities of daily living.
  • If their doctor has told them not to participate in physical activity due to their heart condition or another medical condition, they will be excluded.

• Cancer and are in an active cycle of infusion chemotherapy or daily radiation treatments.

  • People with cancer whose treatment regimen does not impact their day to day routines (e.g.-oral chemotherapy agents) may participate. Research assistants will be trained to ask about the impact of cancer and cancer care on day to day activities and physical activity.
  • If their doctor has told them not to participate in physical activity due to their cancer or cancer treatment or another medical condition, they will be excluded.
• 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.
• 2 or more hospitalizations in 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single arm pre/post study; GAP 12-week Intervention for People Living with Memory Loss & Study Partners involves an evaluation, goal-setting, coaching and strategy training over 4-8 virtual or phone sessions for 30-90 minutes each over 12 weeks, with 2 phone or virtual check-ins for 15-30 minutes. GAP 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.

Behavioral: Green Activity Program; See arm description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility intervention completion rate	intervention completion rate of 75%	Through study completion
Other Feasibility measures	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.	Through study completion
Acceptability	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).	Up to one month after the 12-week program.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: American Federation for Aging Research
• Investigators: Principal Investigator: Rebecca Lassell, PhD, Indiana Unversity

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: October 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease
• Other Study ID Numbers: 22206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No