NCT06735950

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
1.5 years until next milestone

Study Start

First participant enrolled

June 15, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

December 11, 2024

Last Update Submit

March 30, 2026

Conditions

Keywords

apathyassisted livingdementiavolunteering

Outcome Measures

Primary Outcomes (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.

    Baseline, 3 months, 6 months

Secondary Outcomes (1)

  • Motion Watch

    Baseline, 3 months, 6 months

Study Arms (2)

Volunteering-in-Place Program

EXPERIMENTAL

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

Recreational Activity

ACTIVE COMPARATOR

Participants in this arm will engage in a current events group

Behavioral: Recreational activity

Interventions

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
Volunteering-in-Place 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
Recreational Activity

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- refusal to assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LethargyDementia

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Jennifer Klinedinst, PhD, MPH, RN

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Klinedinst, PhD, MPH, RN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 11, 2024

First Posted

December 16, 2024

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.