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NCT Number: NCT06403345

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

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.

Recruiting

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Bloomington

Bloomington, Indiana, 47401, United States

Location status: Recruiting

Location contact

Rebecca Lassell, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Green Activity Program

Behavioral

See arm description.

Primary outcomes

  1. Feasibility intervention completion rate

    Time frame: Through study completion

    intervention completion rate of 75%

  2. Other Feasibility measures

    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.

  3. Acceptability

    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).

Secondary outcomes

  1. Goal Attainment Scaling

    Time frame: Up to one month after the 12-week program

    Primary goal met (yes/no)

  2. Quick Physical Activity Scale

    Time frame: Up to 1 month before and after the 12-week program

    Physical activity

  3. Heart Rate

    Time frame: 1 week pre 12-week program and 1 week post

    ActiGraph LEAP

  4. Physical activity

    Time frame: 1 week pre 12-week program and 1 week post

    ActiGraph LEAP

  5. Sedentary time

    Time frame: 1 week pre 12-week program and 1 week post

    ActiGraph LEAP

  6. Health

    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.

  7. Well-being

    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.

  8. Social Participation

    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.

  9. Depression

    Time frame: Up to 1 month before and after the 12-week program

    Geriatric Depression Scale short form,

  10. Behavioral Activation

    Time frame: Up to 1 month before and after the 12-week program

    Behavioral Activation Scale Short Form

  11. Sleep

    Time frame: 1 week before and 1 week after the 12 week intervention

    ActiGraph LEAP

  12. UCLA 3-item Loneliness scale

    Time frame: Up to 1 month before and after the 12-week program

    Loneliness

  13. Neuropsychiatric symptoms

    Time frame: Up to 1 month before and after the 12-week program

    Neuropsychiatric symptoms questionnaire

  14. Brief phone interviews

    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?"

  15. Study Partner Health

    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.

  16. Study Partner well-being

    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.

  17. Study Partner Social Participation

    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.

  18. Study Partner Depression

    Time frame: Up to 1 month before and after the 12-week program

    Geriatric Depression Scale short form

  19. Feasibility for Study partner

    Time frame: Up to 1 month after the 12-week program

    Feasibility of an Intervention Measure

  20. Acceptability for Study Partner

    Time frame: Up to 1 month after the program

    Acceptability of an Intervention Measure

  21. Appropriateness for Study Partner

    Time frame: Up to 1 month after the 12-week program

    Appropriateness of an Intervention Measure

  22. Brief phone interview

    Time frame: Up to 1 month after the 12-week program

    "What did you like about the program? What would you change?"

  23. Outdoor Professional Dementia Knowledge

    Time frame: Up to 1 month before and after the dementia training

    Dementia Knowledge Assessment

  24. Outdoor Professional strategies for tailoring activities

    Time frame: Up to 1 month before and after the strategy training

    Strategies for Tailoring Activities quiz

  25. Outdoor Professional brief phone interview

    Time frame: Up to 2 weeks after the 12 week program

    15-minute brief phone interview post

  26. Sustained Behavior Change for People Living with Memory Challenges

    Time frame: 1 month after the 12 week program

    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?
  27. Cognitive function

    Time frame: Up to 1 month before and after 12 week program

    T-MoCa

  28. Usability

    Time frame: up to 2 weeks after baseline testing with the ActiGraph LEAP and CenterePointe App software

    Holden's Simplified Systems Usability Scale (SSUS)

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Lassell, PhD

CONTACT

[email protected]

812-855-2395

Triana Pena

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • American Federation for Aging Research

Registry information

Acronym: GAP

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 7, 2024
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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