A Green Activity Prescription Program for Hispanic/Latino (Latinx) Persons Living With Dementia

Alzheimer Disease Clinical Trial

— GAP-H  

Official title:

A Green Activity Prescription Program for Hispanic/Latino (Latinx) Persons Living With Mild Cognitive Impairment and Mild Dementia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06403345
• Other study ID #: 22206
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: June 2024
• Source: Indiana University
• Contact: Rebecca Lassell, PhD
• Phone: 812-855-2395
• Email: blassell[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the Green Activity Program that was designed with Hispanic/Latino 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.

Description:

This is a single arm pre/post feasibility study lasting up to 1 year. Investigators will recruit in n=40 dyads (Hispanic/Latino 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-H 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 60 years or older

• Identify as Hispanic/Latino

• Speaks Spanish or English

• T-MoCA scores 13-19

• Capacity to provide informed consent

• Have access and ability to respond to the telephone (mobile or landline)

Study partner

• 18 years or older

• Identify as Hispanic/Latino

• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

Behavioral:
• Green Activity Program
See arm description.

Locations

Country	Name	City	State
United States	Indiana University Bloomington	Bloomington	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	American Federation for Aging Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility intervention completion rate	intervention completion rate of 75%	Through study completion
Primary	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
Primary	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	Goal Attainment Scaling	Primary goal met (yes/no)	Up to one month after the 12-week program
Secondary	Quick Physical Activity Scale	Physical activity	Up to 1 month before and after the 12-week program
Secondary	Heart Rate	ActiGraph LEAP	1 week pre 12-week program and 1 week post
Secondary	Physical activity	ActiGraph LEAP	1 week pre 12-week program and 1 week post
Secondary	Sedentary time	ActiGraph LEAP	1 week pre 12-week program and 1 week post
Secondary	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
Secondary	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
Secondary	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
Secondary	Depression	Geriatric Depression Scale short form,	Up to 1 month before and after the 12-week program
Secondary	Behavioral Activation	Behavioral Activation Scale Short Form	Up to 1 month before and after the 12-week program
Secondary	Sleep	ActiGraph LEAP	1 week before and 1 week after the 12 week intervention
Secondary	UCLA 3-item Loneliness scale	Loneliness	Up to 1 month before and after the 12-week program
Secondary	Neuropsychiatric symptoms	Neuropsychiatric symptoms questionnaire	Up to 1 month before and after the 12-week program
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Study Partner Depression	Geriatric Depression Scale short form	Up to 1 month before and after the 12-week program
Secondary	Feasibility for Study partner	Feasibility of an Intervention Measure	Up to 1 month after the 12-week program
Secondary	Acceptability for Study Partner	Acceptability of an Intervention Measure	Up to 1 month after the program
Secondary	Appropriateness for Study Partner	Appropriateness of an Intervention Measure	Up to 1 month after the 12-week program
Secondary	Brief phone interview	"What did you like about the program? What would you change?"	Up to 1 month after the 12-week program
Secondary	Outdoor Professional Dementia Knowledge	Dementia Knowledge Assessment	Up to 1 month before and after the dementia training
Secondary	Outdoor Professional strategies for tailoring activities	Strategies for Tailoring Activities quiz	Up to 1 month before and after the strategy training
Secondary	Outdoor Professional brief phone interview	15-minute brief phone interview post	Up to 2 weeks after the 12 week program
Secondary	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
Secondary	Cognitive function	T-MoCa	Up to 1 month before and after 12 week program