The Volunteering-in-Place Program for Apathetic Assisted Living Residents With ADRD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 200
- Primary Endpoint
- Apathy Evaluation Scale
Study Overview
Brief Summary
This is a research study to test two different interventions to decrease apathy in assisted living residents with some memory issues. Apathy makes older adults not feel like doing much activity. This study is completely voluntary and will not affect the care you receive at your assisted living community.
The two possible interventions are 1) participation in a volunteering opportunity within the assisted living community OR 2) participation in a guided current events group within the assisted living community. These activities would be in addition to any other regular activities you participate in within the assisted living community. Both activities would take place three days per week for approximately 30 minutes. You would be randomly assigned (like a coin flip) to which intervention you would do. You do not get to choose. You would participate in the activity for a total of 6 months.
In addition to participating in the intervention (either volunteering or current events), you will be asked to answer some questions about your memory, level of activity, mood, confidence in your ability to do a volunteer job, and feelings of usefulness. You will answer these questions at baseline (before the activity begins, at 3 months after doing the intervention activity, and aging at 6 months after starting the interventions activity. You will also be asked to wear a MotionWatch for 5 days at each time point (baseline, 3months and 6 months). A motion watch measures your level of activity. It feels like wearing a regular watch. You will be in the study for 6 months total.
Risks to participating in this study are minimal and include privacy (other people may find out you are in the study), confidentiality of the data collected if someone other than study staff accesses your records, fatigue with answering the questionnaires, and some mild discomfort with wearing the MotionWatch. This is also a minor risk that you could fall or otherwise harm yourself getting to or participating in your intervention activity.
The benefit of participating in this study include possible enjoyment of participating in the intervention activity.
Detailed Description
Our Primary aim is to test the preliminary efficacy of the VIP Program to decrease apathy and sedentary activity among apathetic AL residents with mild to moderate ADRD at 3 and 6 months post implementation. Hypothesis 1.1: Participants in the VIP Program will have a decrease in apathy and a decrease in time spent in sedentary activity when compared to residents exposed to RA only at 3 and 6 months post implementation of the intervention. This study will use a cluster randomized control trial with a repeated measures design. A total of 4 AL communities will be randomized to treatment [Volunteering-in-Place (VIP) Program intervention] or time equivalent control [current events group]. Randomization will occur via random number generator at the facility level rather than at the individual level in order to control for carryover of VIP Program activities. Data will be collected at baseline, 3 and 6 months post initiation of the VIP Program. The 3 month time point was chosen as it takes at least three months for the VIP Program interventions to become ingrained into the residents routine and to impact apathy outcomes. We will assess for effects at 6 months as this time point is indicative of longer-term behavior change and evidence of sustainability of the program and resident and staff participation.
The Assisted Living communities included in this study will be located in the State of Maryland. We will randomly select from the 10 total AL communities across these provider organizations to contact and enroll specific sites. To be eligible to volunteer to participate in the study the AL community will need to: (1) have at least 100 beds; and (2) identify a stakeholder team and champion to work with us throughout the study period. AL communities will be excluded if they have an existing in-house volunteer program for residents with ADRD.
Potential participants will have an opportunity to learn about the study via the resident and family information sessions.
Resident recruitment will be done in person by obtaining a list of all potentially eligible residents from a designated staff member and randomly approaching each resident until 27-28 residents per setting are fully enrolled by research team evaluators. Residents who meet initial inclusion criteria will be given an Evaluation to Sign Consent and if they pass they will continue with the full consent process. If they do not pass the Evaluation to Sign Consent, they will be asked to verbally provide assent and the Legally Authorized Representative will be approached to complete the consenting process.
Once consent is obtained, cognitive testing and an apathy screening will be done by a trained evaluator to determine eligibility. Residents will be considered to have mild to moderate ADRD if they have a score of 26 or below on the Saint Louis University Mental Status Exam (SLUMS) and can follow a one step command ("touch your nose"). The evaluator will collect the data on the SLUMS and assess the ability to follow a one step command from the resident. Once eligibility for cognitive impairment has been established, a family member or a direct care worker familiar with the participant's behavior over the past month would complete the Neuropsychiatric Inventory (NPI) apathy subscale about the resident. Residents who have a "yes" answer to at least 2 questions on the apathy subscale of the NPI will be enrolled.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age 55 years or older;
- •English speaking;
- •live in the included AL community
- •have mild to moderate cognitive impairment based on a SLUMS score of 26 or below and the ability to follow a one-step command.
- •have apathy based on a "yes" answer to at least 2 questions on the apathy subscale of the Neuropsychiatric Inventory (NPI) completed by a family or staff member who has had close contact with the resident in the past month;
- •have an anticipated length of stay of 12 months.
Exclusion Criteria
- •- refusal to assent
Arms & Interventions
Recreational Activity
Participants in this arm will engage in a current events group
Intervention: Recreational activity (Behavioral)
Volunteering-in-Place Program
Participants in this arm will engage in a volunteer activity in the assisted living facility chosen based on their interests and capabilities.
Intervention: Volunteering in Place Program (Behavioral)
Outcomes
Primary Outcomes
Apathy Evaluation Scale
Time Frame: Baseline, 3 months, 6 months
The Apathy Evaluation Scale-Informant (AES-I) will be used to assess apathy. The AES-I has 18 items that assess cognitive, behavioral, and emotional aspects of apathy. The scale has good psychometric properties when used to assess apathy in adults with dementia. The total score ranges from 18 to 72, with higher scores indicating more apathy.
Secondary Outcomes
- Motion Watch(Baseline, 3 months, 6 months)
Investigators
Jennifer Klinedinst
Associate Professor
University of Maryland, Baltimore