A Feasiblity Study of Green Activity Program for People Living With Memory Challenges
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorIndiana University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
45 years or older
Has memory challenges or difficulties thinking
Have access and ability to respond to the telephone (mobile or landline)
18 years or older
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Green Activity Program
BehavioralSee arm description.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Single arm pre/post studyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility intervention completion rate
intervention completion rate of 75%
Time frame
Through study completion2
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.
Time frame
Through study completion3
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).
Time frame
Up to one month after the 12-week program.Secondary outcomes
1
Goal Attainment Scaling
Primary goal met (yes/no)
Time frame
Up to one month after the 12-week program2
Quick Physical Activity Scale
Physical activity
Time frame
Up to 1 month before and after the 12-week program3
Heart Rate
ActiGraph LEAP
Time frame
1 week pre 12-week program and 1 week post4
Physical activity
ActiGraph LEAP
Time frame
1 week pre 12-week program and 1 week postSponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
American Federation for Aging Research
Collaborator
Source ClinicalTrials.gov