NCT06735950 · University of Maryland, Baltimore
The Volunteering-in-Place Program for Apathetic Assisted Living Residents With ADRD
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Volunteering in Place Program
Implementation of the VIP Program consists of 4 steps guided by the Social Ecological Model (SEM) with Interpersonal interventions guided by Social Cognitive Theory (SCT), and will be implemented over a 6-month period by research supported Volunteer Coordinators. The four steps of the VIP Program are: Step 1: Stakeholder Team, Staff and Family Education; Step 2: Assessment of AL Environment and Residents Abilities and Interests; Step 3: Ongoing Implementation of the Volunteer Plan; and Step 4: Reassessment of the Volunteer Activity. Participants will volunteer three time per week for approximately 30 minutes.
BEHAVIORAL
Recreational activity
The Recreational Activities group intervention will consist of similar staff education regarding the benefits of engaging residents in meaningful activities as described in Step 1 above, without other steps associated with the VIP Program. The Recreational Activities group will be exposed to a research team RA coordinator who will provide a current events activity (reviewing the daily newspaper) for the participants in the RA group three times per week for approximately 30 minutes as an attention control.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Catonsville, Maryland
- Rockville, Maryland
Collaborators
National Institute on Aging (NIA)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 5, 2026 · Source of record for eligibility and locations