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Behavioral Intervention

Green Activity Program for Dementia (GAP-H Trial)

N/A
Recruiting
Led By Rebecca Lassell, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
60 years or older
Capacity to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 month before and after 12 week program
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a program called the Green Activity Program for Hispanic/Latino individuals with memory challenges and their study partners. The program involves engaging in nature activities, such as dog walking, hiking

Who is the study for?
This trial is for Hispanic/Latino individuals aged 60 or older with memory challenges, such as mild cognitive impairment or early-stage dementia. Participants must speak Spanish or English, be able to use a phone, and have a trusted study partner willing to join them in the program.
What is being tested?
The Green Activity Program is being tested for its feasibility and enjoyment among participants. It involves nature-related activities like dog walking, hiking, outdoor yoga, and gardening aimed at improving activity levels and overall well-being.
What are the potential side effects?
Since this program focuses on physical activities in nature, potential side effects may include typical exercise-related risks such as muscle strains or falls. However, these are generally low-risk activities designed to be enjoyable and safe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 60 years old or older.
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I am able to understand and agree to the study's procedures and risks.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 month before and after the 12-week program
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month before and after the 12-week program for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability
Feasibility intervention completion rate
Other Feasibility measures
Secondary study objectives
Acceptability for Study Partner
Appropriateness for Study Partner
Behavioral Activation
+25 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single arm pre/post studyExperimental Treatment1 Intervention
GAP-H 12-week Intervention for People Living with Memory Loss \& Study Partners involves an OT evaluation, goal-setting, coaching and strategy training over 4-8 in-person sessions for 30-90 minutes each over 12 weeks, with 2 phone or virtual check-ins for 15-30 minutes. GAP-H 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.

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Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,034 Previous Clinical Trials
1,119,132 Total Patients Enrolled
American Federation for Aging ResearchOTHER
8 Previous Clinical Trials
1,998 Total Patients Enrolled
Rebecca Lassell, PhDPrincipal InvestigatorIndiana Unversity
~27 spots leftby Jul 2025
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