Impact of Social Support Through Personalized Visits on Behavioral Symptoms in Residential Care

NCT07844980 | Completed

• 1 other identifier: 2126521-6
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to determine if individual social support sessions with personalized conversation prompts could have an impact on behavioral symptoms of dementia. The primary research questions this study wanted to answer were:

1. 1.Does social support through personalized social visits improve behavioral symptoms of dementia?
2. 2.Does social support through personalized visits affect loneliness in adults with dementia in residential care?
3. 3.Do hospitalization visits (emergency room evaluations or inpatient behavioral admissions) change as a result of social support visits?
4. 4.Does the level of dementia impact outcomes such as behavioral symptoms, loneliness levels, or engagement?
5. 5.Do adults with dementia in residential care enjoy social support visits?

Conditions

Dementia

Keywords

social support; dementia; non-pharmacological

Outcome Measures

Primary Outcomes (2)

• Primary Outcome: Change in Neuropsychiatric symptoms as measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q)

  The Neuropsychiatric Inventory Questionnaire (NPI-Q) is a caregiver/informant-report measure assessing the presence and severity of 12 neuropsychiatric symptom domains commonly associated with dementia (e.g., delusions, agitation, depression, anxiety, apathy, irritability). For each domain, caregivers rate symptom severity (1-3) and caregiver distress (0-5). A total severity score is calculated by summing the severity ratings across domains, with higher scores indicating greater neuropsychiatric symptom burden. Change scores were calculated by comparing total severity scores at baseline (one week pre-intervention) to scores at one week post-intervention (following the 12-week intervention period).

  Baseline (1 week before the intervention) and one week following the 12-week intervention

• Change in Perceived loneliness as measured by the DeJong Gierveld Loneliness Scale (6-item short form)

  The De Jong Gierveld Loneliness Scale (6-item short form) is a self-report measure assessing subjective feelings of loneliness, encompassing both emotional loneliness (the perceived absence of an intimate relationship) and social loneliness (the perceived absence of a wider social network). The short form consists of 6 items, each rated as "yes," "more or less," or "no," yielding a total loneliness score ranging from 0 to 6, with higher scores indicating greater loneliness. Change scores were calculated by comparing total scores at baseline (one week pre-intervention) to scores at one week post-intervention (following the 12-week intervention period).

  Baseline (1 week prior to the start of the 12-week intervention) and 1 week following completion of the 12-week intervention

Secondary Outcomes (2)

• Change in Mood as Measured by the Face Scale

  Twice weekly for 12 weeks (pre- and post-visit at each session); mean pre- and post-scores calculated per participant across all visits.

• Psychiatric hospitalizations/evaluations changes

  3 months prior to intervention and 3 months following intervention

Study Arms (2)

Social Visits

EXPERIMENTAL

Individualized social visits from a CTRS (25 min, twice/week), in addition to standard programming

Behavioral: Social Visits

Traditional recreational group programming

ACTIVE COMPARATOR

traditional group activity programming only (chair exercises, bingo, arts and crafts, food socials)

Behavioral: Traditional Activity programming

Interventions

Social Visits BEHAVIORAL

Participants received 2, 30 minute social visits with a standardized script which included two personalized questions for 12 weeks.

Social Visits

Traditional Activity programming BEHAVIORAL

Participants were provided with traditional activity programming within the facility without the addition of social visits.

Traditional recreational group programming

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of a neurocognitive disorder with behavioral symptoms
• Ability to process and respond too simple questions
• Signed consent forms from primary representative 55 or older

You may not qualify if:

• No diagnosis of a neurocognitive disorder
• Lack of signed consent from primary representative
• Inability to process or answer simple questions

Sponsors & Collaborators

• University of South Alabama: lead

Study Sites (1)

Confidential

Bay Minette, Alabama, 36507, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Carolyn M. Bates, PhD

  University of South Alabama

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Caregivers providing behavioral symptom information for the NPI-Q were blinded to participant group assignment. The CTRS administering the NPI-Q and trained research assistants delivering the intervention were not blinded. Perceived loneliness (DGLS) was self-reported directly by participants, who were inherently aware of their own group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 28, 2026
• Study Start: March 3, 2024
• Primary Completion: August 2, 2024
• Study Completion: February 19, 2025
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 9-2-26 through 9-3-27
• Access Criteria: IPD and supporting information can be provided upon request. IPD includes outcome measures only. No identifiable information.

Locations

US (1)