NCT06866015

Brief Summary

The goal of this pilot study is to verify the short-term effectiveness of the Activation-Socialisation Intervention Programme (A-S IP) on the psychosocial survival of older adults in a specific care facility. The main questions it aims to answer are:

  • Does the A-S IP reduce the rate of negative emotional states in older adults?
  • Does the A-S IP increase the rate of positive emotional states in older adults?
  • Does the A-S IP reduce feelings of loneliness in older adults? Researchers will compare the experimental group (older adults participating in the A-S IP) to a control group (older adults not participating in the intervention) to assess the impact on emotional states and loneliness. Participants will:
  • Participate in 40 activities based on three domains (Laughter Therapy, Reminiscence Therapy, and Cognitive and Social Skills Stimulation)
  • Engage in group activities for four weeks, with daily sessions scheduled in the morning and afternoon
  • Provide feedback on their experiences through surveys and questionnaires to assess their emotional states and satisfaction with the intervention The study will also explore whether the intervention contributes to the well-being of older adults, as measured by changes in their emotional states and feelings of loneliness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 4, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2021

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

February 24, 2025

Last Update Submit

March 13, 2025

Conditions

Keywords

older adultelderly care facilitiesintervention programmeemotionsloneliness

Outcome Measures

Primary Outcomes (1)

  • the Scale of Emotional Habitual Subjective Well-being - SEHP (Džuka & Dalbert, 2002)

    The Scale of Emotional Habituation of Subjective Well-Being - SEHP (Džuka \& Dalbert, 2002) was used to examine the short-term effectiveness of the intervention programme. The self-esteem scale maps the frequency of experiencing positive and negative emotions, totalling 10. Negative emotional experiencing consists of six emotions such as anger, guilt, fear, pain, sadness, and shame, positive emotional experiencing consists of pleasure, physical freshness, joy, and happiness. The participants responded on a six-point scale (6 - almost always; 1 - almost never). The total score of negative emotions is the sum of negative emotions, and the total score of positive emotions is the sum of positive emotions (Džuka et al., 2021). An additional variable, loneliness, was added to the scale. It was assessed on an identical six-point scale. Unit of Measure: Score (Total score for positive and negative emotions)

    one month

Study Arms (1)

Activation-socialization interventiom programme

EXPERIMENTAL
Other: Activation-socialization intervention programme

Interventions

The proposed A-S IP (Author, 2021) includes 40 activities of three domains focusing mainly on the social-psychological level of education: the Laughter Therapy Concept (13), the Reminiscence Therapy Concept (13), and the Cognitive and Social Skills Stimulation Intervention Concept (14). The implementation of the A-S IP activities was designed for a time period of four weeks during weekdays. In the Hriňovčan care facility for older adults, mainly in the common room, two activities were implemented daily during the morning and afternoon hours reserved for this purpose. Morning activities (active) were from 10:00 to 11:00 a.m., and afternoon activities (passive) were from 1:00 to 2:00 p.m. The application of the activities was strictly determined and organised according to a time-thematic schedule that applied rules. The participants participated in group activities, and their participation was voluntary.

Activation-socialization interventiom programme

Eligibility Criteria

Age62 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • long-term residence in the facility,
  • age over 62,
  • willingness to participate,
  • ability to participate (no severe cognitive or physical impairments)

You may not qualify if:

  • significant physical problems,
  • significant mental health problems,
  • unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hriňovčan care facility for older adults

Hriňová, Slovakia, 96205, Slovakia

Location

Study Officials

  • Diana Ďuricová, PhDr.

    Matej Bel University

    PRINCIPAL INVESTIGATOR
  • Lenka Ďuricová, doc., Mgr., PhD.

    Matej Bel University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2025

First Posted

March 10, 2025

Study Start

February 4, 2021

Primary Completion

March 8, 2021

Study Completion

March 30, 2021

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations