Clinical trial NCT06866015: Activation Programme's Impact on Seniors' Emotionality and Loneliness
Official title: The Impact of an Activation-Socialisation Intervention Programme on the Emotionality and Loneliness of Older Adults in Slovak Elderly Care Facilities - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional States
Loneliness
Seniors
Keywords: older adult
elderly care facilities
intervention programme
emotions
loneliness
Lead sponsor: Matej Bel University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 41
Sex: ALL
Minimum age (years): 62
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The study was registered retrospectively due to limited awareness of the registration requirement for behavioral interventions at the time of study initiation (in 2021). Initially, the research was designed as an exploratory study on a smaller scale, and the registration of a formal trial was not considered necessary.

As an early-career researcher and doctoral student, I was not initially aware of the necessity of registering behavioral intervention studies. However, as the study progressed and its significance became evident, I came to understand the importance of this process. Once I became aware of the registration requirements, I took the necessary steps to complete it accordingly.

Despite the late registration, the study was conducted according to a pre-specified protocol, with all methodological and ethical standards strictly adhered to (approved, for example, by the Ethics Committee of UMB). The hypotheses, study design, and analysis plan were defined prior to data collection, ensuring the integrity and transparency of the research.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: the Scale of Emotional Habitual Subjective Well-being - SEHP (Džuka & Dalbert, 2002)
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Hriňová
country: Slovakia
facility: Hriňovčan care facility for older adults
Study officials:
affiliation: Matej Bel University
name: Diana Ďuricová, PhDr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Matej Bel University
name: Lenka Ďuricová, doc., Mgr., PhD.
role: STUDY_DIRECTOR
References: