Clinical trial NCT06632145: Cog-Fun Ageing Participation-centered, Health Promotion for Older Adults
Official title: Cog-Fun Ageing Participation-centered, Health Promotion for Older Adult
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subjective Cognitive Decline (SCD)
Keywords: Occupational experience
Participation
Cognitive functional interventions
Functional decline
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre post pilot feasibility study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this feasibility study is to test the feasibility of a group intervention program based on health management principles for older adults with Subjective Cognitive Decline (SCD). SCD is a condition where individuals feel that their memory is worsening, although standard tests do not detect it. This perceived memory decline can lead to negative feelings and self-perception, causing people to withdraw from meaningful activities.

This study aims to answer three main questions:

1. Is the intervention feasible in terms of fidelity, adherence, and participant satisfaction?
2. Are the assessments used sensitive enough to identify the unique challenges faced by the SCD population and detect changes after the intervention?
3. What are the preliminary effects of the intervention on participants' perceptions of how SCD affects their daily life, mental health, and quality of life?

Participants will:

1. Take part in 14 weekly group sessions focused on managing the challenges of living with SCD and improving participation in daily activities.
2. Complete assessments before and after the intervention to measure their satisfaction with the program, and track changes in their perceptions of daily life, mental health, and quality of life.


Eligibility criteria: Inclusion Criteria:

* Self-reported memory changes,
* A score of 23 or higher on the Montreal Cognitive Assessment (MoCA)
* Proficiency in Hebrew to participate fully in a Hebrew-speaking group.

Exclusion Criteria:

* Presence of a significant health condition that affects functioning
* Residence in a medical institution or nursing home
* Current participation in another SCD treatment

Primary outcomes:
measure: Memory Impact Questionnaire (MIQ)
timeFrame: After enrollment (before intervention) and 14 weeks later (after intervention)
Secondary outcomes:
measure: Patient Health Questionnaire -4 (PHQ-4 )
timeFrame: After enrollment (before intervention) and 14 weeks later (after intervention)
measure: SHARE version of the CASP-12
timeFrame: After enrollment (before intervention) and 14 weeks later (after intervention)
measure: Engagement in Meaningful Activities Survey (EMAS)
timeFrame: After enrollment (before intervention) and 14 weeks later (after intervention)
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hebrew University of Jerusalem
Study officials:
affiliation: School of occupational therapy, faculty of medicine, Hebrew University
name: Adina Maeir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roheger M, Hennersdorf XS, Riemann S, Floel A, Meinzer M. A systematic review and network meta-analysis of interventions for subjective cognitive decline. Alzheimers Dement (N Y). 2021 Jul 12;7(1):e12180. doi: 10.1002/trc2.12180. eCollection 2021.
citation: Rotenberg S, Leung C, Quach H, Anderson ND, Dawson DR. Occupational performance issues in older adults with subjective cognitive decline. Disabil Rehabil. 2022 Aug;44(17):4681-4688. doi: 10.1080/09638288.2021.1916626. Epub 2021 May 14.