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| Name | Class |
|---|---|
| American Federation for Aging Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm pre/post study | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Green Activity Program | Behavioral | See arm description. |
|
| 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. |
| 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 |
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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+) :
Heart failure or, difficulty controlling Coronary Artery Disease, Diagnosed Abnormality of Heart Rhythm, or other cardiovascular condition.
Cancer and are in an active cycle of infusion chemotherapy or daily radiation treatments.
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Lassell, PhD | Contact | 812-855-2395 | blassell@iu.edu | |
| Triana Pena | Contact | tripena@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Lassell, PhD | Indiana Unversity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Bloomington | Recruiting | Bloomington | Indiana | 47401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41092385 | Derived | Lassell R, Metaxas A, Wang K, Hantgan S, Gottipati P, Zwerling S, Pena T, Pollak C, Gitlin L, Jariwala S. Applying the Human-Centered Innovation Biodesign Framework to the Development and Piloting of a Program to Mitigate Risk for Cognitive Decline Among Historically Underrepresented Individuals: Case Study. JMIR Form Res. 2025 Oct 15;9:e64930. doi: 10.2196/64930. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| 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 |
| Behavioral Activation | Behavioral Activation 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
| 1 month after the 12 week program |
| Cognitive function | T-MoCa | Up to 1 month before and after 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 |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |