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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Green Activity Program
  See arm description.

Первичные конечные точки

• Feasibility intervention completion rate [Срок оценки: Through study completion]
• Other Feasibility measures [Срок оценки: Through study completion]
• Acceptability [Срок оценки: Up to one month after the 12-week program.]

Вторичные конечные точки (12)

• Goal Attainment Scaling [Срок оценки: Up to one month after the 12-week program]
• Quick Physical Activity Scale [Срок оценки: Up to 1 month before and after the 12-week program]
• Heart Rate [Срок оценки: 1 week pre 12-week program and 1 week post]
• Physical activity [Срок оценки: 1 week pre 12-week program and 1 week post]
• Sedentary time [Срок оценки: 1 week pre 12-week program and 1 week post]
• Health [Срок оценки: Up to 1 month before and after the 12-week program]
• Well-being [Срок оценки: Up to 1 month before and after the 12-week program]
• Social Participation [Срок оценки: Up to 1 month before and after the 12-week program]
• Depression [Срок оценки: Up to 1 month before and after the 12-week program]
• Behavioral Activation [Срок оценки: Up to 1 month before and after the 12-week program]
• Sleep [Срок оценки: 1 week before and 1 week after the 12 week intervention]
• UCLA 3-item Loneliness scale [Срок оценки: Up to 1 month before and after the 12-week program]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Indiana University Bloomington — Bloomington

Публикации

• 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. PMID 41092385

Идентификаторы

NCT: NCT06403345 · 22206

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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