An interventional study of Volunteering in Place Program and Recreational activity in Apathy in Dementia, sponsored by University of Maryland, Baltimore. Recruiting at 2 sites in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Supportive care
Among 1,049 studies in Dementia with a site in United States — 211 open to participants now, 278 under way, 15 of them phase 3. Dementia · United States.
Among the 1,049 studies in Dementia with a site in United States, this one is the 265th largest by planned enrollment of the 845 interventional ones, is one of 66 that started in 2026, is one of 561 with no phase, reaches primary completion later than 164 of the 277 other live ones, and was the 932nd registered.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's planned enrollment of 200 is above the median of 90 across 1,758 interventional studies indexed under Dementia.
Browse Dementia studies →211 of the 1,049 studies in Dementia with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 381 Dementia studies recruiting now, 242 (64%) set no upper age limit and 25 (7%) stop at 75 or younger; 16 take children under 18; 163 take healthy volunteers.
This study: 55 Years and older · all sexes · no healthy volunteers.
The full table on the hub →1,049 studies; the count open now beside each. This study's row is marked.
First in 1981; this study’s year is marked. 66 started in 2026.
Median enrollment 92 across the 845 interventional studies, 200 across the 199 observational. Of the 712 that completed or were terminated, 308 (43%) have results posted.
191 of 1,049 have an industry lead sponsor. The 10 most frequent:
University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
University of Maryland, Baltimore has 8 studies filed under Dementia — fewer than ten, so there is no comparison to draw.
109 of the studies in Dementia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05543681IGC Pharma, LLCClinical Trial on Agitation in Alzheimer's Dementia | 2026-11 |
| NCT07430371Rendever, Inc.Virtual Reality for Caregiver Assembly, Relief, Empowerment, and Support (VR-CARES) | 2026-11 |
| NCT06147999First Institute of All MedicinesImpact of a Biophoton Therapy on Patients With Brain Disorders | 2026-11-08 |
| NCT06095284Virginia Commonwealth UniversityPrescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic | 2026-11-30 |
| NCT06298474Hopeful AgingThe BRAIN App (Phase 2 SBIR) | 2026-11-30 |
Among the 1,049 studies in Dementia with a site in United States, from their registry updates:
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.
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.
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. Each part of the SEM addresses a portion of the resident, caregiver and environmental stressors that contribute to apathy. The Volunteer Coordinators will have experience working with older adults with ADRD. The Volunteer Coordinator will work 20 hours per week for the 6-month intervention period. In addition, the Volunteer Coordinator will work with the stakeholder team to identify a Staff Champion to work with the Volunteer Coordinator on the VIP Program to optimize implementation and assure sustainability. The Volunteer Coordinator and Staff Champion will meet monthly with the stakeholder team to make sure that the resident volunteer activities are supported by the facility employees and to problem solve any challenges related to the VIP Program (e.g., resistance of staff to help residents get to volunteer activities).
Separate interventionists will be used for the Recreational Activities Only (current events) group to prevent crossover effects. The Recreational Activities group intervention will consist of similar staff education regarding the benefits of engaging residents in meaningful activities as the VIP intervention, without other steps associated with the VIP Program. Prior research has repeatedly demonstrated that education alone in these settings is insufficient to alter staff or resident behavior. 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. This control intervention provides some opportunity for engagement in activities but there is no development of a person-centered volunteer activity that is meaningful to the individual and no interventions to strengthen self-efficacy expectations about volunteering or participating and no focus on imparting feelings of usefulness as the mechanism to decrease apathy. Moreover, it is consistent with usual types of activities provided in AL.
Data will be collected at baseline, 3 and 6 months. All data will be collected by a trained research evaluator.
AL Facility Descriptive Data: AL facility size, staffing levels (number of RNs, LPNs, direct care workers, activity staff), and highest level of care provided (level 1, 2, 3) will be obtained at baseline from the AL Administrator or designee for each community and will be considered as covariates.
Once enrolled: Resident participants will complete baseline questionnaires with input from a direct care worker if necessary. These questionnaires include the Apathy Evaluation Scale, the Yale Physical Activity Survey-Recreational activity subscale modified for assisted living residents, the Cornell Scale for Depression in Dementia, three questions on feelings of usefulness, and three questions on self-efficacy or volunteering. In addition, participants will wear a motion watch (accelerometer) for 5 weekdays to assess sedentary behavior. These questionnaires and Motion watch measures will be repeated at 3 post intervention and 6 months post intervention. At baseline, we will collect descriptive data including resident age, race, gender, ethnicity, marital status, length of time residing in AL, and education from the AL clinical record. At each time point, we will also collect medications, comorbidities - using the Cumulative Illness Rating Scale, falls, hospitalizations, emergency room visits and transfers to a higher level of care such as a skilled nursing facility.
Participants randomized to the VIP Program:
After completing baseline measures, residents in the VIP Program intervention will meet with the Volunteer Coordinator (interventionist) and/or Staff Champion (AL staff member interventionist) at a mutually convenient day/time for an assessment of their Interests, Physical Capability Scale and for input regarding their volunteer plan. (VIP Program Step 2) This should take approximately 30 minutes, but could be divided into multiple sessions to provide breaks for the resident. Once the resident and Volunteer Coordinator decide on a volunteer activity and plan, the resident will begin volunteering 3 days per week for 30 minutes each time for 6 months. (VIP Program Step 3) The Volunteer Coordinator and other staff will implement the appropriate self-efficacy based motivational strategies. The Volunteer Coordinator and/or Staff Champion will elicit feedback from the resident regarding their enjoyment of the volunteer activity using the Resident Evaluation of Volunteer Experience form. However, residents will be encouraged to provide feedback regarding the activity to the Volunteer Coordinator any time they desire or are not happy with the activity for any reason. The Volunteer Coordinator or Staff Champion will make adjustments to the Volunteer Activity or address any issues with input from the resident, study staff and stakeholder team.
For Participants in the Recreational Activities Control Group:
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. Separate interventionists will be used for the VIP vs. Recreational Activities groups to reduce crossover effects. Prior research has repeatedly demonstrated that education alone in these settings is insufficient to alter staff or resident behavior. The Recreational Activities group will be exposed to a research interventionist 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. This control intervention provides some opportunity for engagement in activities but there is no development of a person-centered volunteer activity that is meaningful to the individual and no interventions to strengthen self-efficacy expectations about volunteering or participating and no focus on imparting feelings of usefulness as the mechanism to decrease apathy. Participation in the current events activity will be tracked for treatment fidelity using the same Participation Index as the VIP Program intervention.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- refusal to assent
Participants in this arm will engage in a volunteer activity in the assisted living facility chosen based on their interests and capabilities.
Behavioral: Volunteering in Place Program
Participants in this arm will engage in a current events group
Behavioral: Recreational activity
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.
Also known as: VIP Program
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.
Also known as: Current events group
Apathy Evaluation Scale
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.
Time frame: Baseline, 3 months, 6 months
Motion Watch
Objective sedentary activity will be obtained using three full weekdays of data from the MotionWatch 8©, a lightweight waterproof wrist worn tri-axial accelerometer that reliably measures activity in 60 second epochs of time.98 The resident will wear the MotionWatch for five days and the first and last day of data will not be included so as to get three complete days of data. The MotionWatch 8© contains a miniature accelerometer to allow measurement and recording of physical movement of the wrist which provides a close correlation to whole body movement. Reliability, validity, and cut points for different levels of activity have been established for older adults. Specifically we will collect counts of activity and time spent in sedentary activity during weekdays where the volunteer activity or recreational activity took place as this is when we expect to see changes in sedentary activity.
Time frame: Baseline, 3 months, 6 months
Plan to share: Yes — Data will be deposited in a data repository after the completion of the study.
Time frame: after the conclusion of the study data will be stored in the repository indefinitely
Access criteria: People with access to the specified repository.
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Aug 2027, 10 months after the start.
Of 855 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 10 months is below that.
Counting every sponsor, half of 901 studies reached it within 25 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Maryland, Baltimore →