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Apathy in DementiaNCT06735950

The Volunteering-in-Place Program for Apathetic Assisted Living Residents With ADRD

A study testing Volunteering in Place Program and Recreational activity in people with Apathy in Dementia, run by University of Maryland, Baltimore at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Apathy in Dementia
What is being tested?
Volunteering in Place Program and Recreational activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesUnited States
Study dates
1 Oct 2026to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • refusal to assent

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer Klinedinst, PhD, MPH, RN contact

410-706-3181

klinedinst@umaryland.edu

United States2 sites, 2 recruiting
  • Charlestown Senior Living

    Catonsville, Maryland, 21228

    Maksim Mendelzon, 410-737-8875, Maksim.Mendelzon@erickson.com

    Recruiting
  • Charles E Smith Life Communities

    Rockville, Maryland, 20852

    Elisa Gil-Pires, MD, FACP, CMD, CPE, 301-770-8473, gil-pires@ceslc.org

    Kathleen Triggs, 301-816-5056, triggs@ceslc.org

    Recruiting

Other trials in United States

About this study

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.

Read more

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.

Read the 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.

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.

Being tested
Volunteering in Place Program, Recreational activity
Keywords
apathy, assisted living, dementia, volunteering
Medical subject headings
Lethargy, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Volunteering in Place ProgramBehavioural

    Also called VIP 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.

  • Recreational activityBehavioural

    Also called Current events 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. 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.

Study groups in NCT06735950
Study groupRoleWhat they receive
Volunteering-in-Place ProgramExperimentalParticipants in this arm will engage in a volunteer activity in the assisted living facility chosen based on their interests and capabilities.
Receives: Behavioral: Volunteering in Place Program
Recreational ActivityActive comparatorParticipants in this arm will engage in a current events group
Receives: Behavioral: Recreational activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 3 months, 6 months

Secondary outcomes (1)
  1. 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.

    Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2024
  2. Study start1 Oct 2026
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06735950
Sponsor's protocol ID
HP-00112822
Other IDs
1R61AG088468-01A1
Status last verified
Oct 2026
First submitted
11 Dec 2024
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be deposited in a data repository after the completion of the study.

Questions about this trial

What is this clinical trial studying?

A study testing Volunteering in Place Program and Recreational activity in people with Apathy in Dementia, run by University of Maryland, Baltimore at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Klinedinst, PhD, MPH, RN (410-706-3181, klinedinst@umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apathy Evaluation Scale (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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