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Clinical Trials/NCT06632145
NCT06632145
Recruiting
Not Applicable

Cog-Fun Ageing Participation-centered, Health Promotion for Older Adult

Hebrew University of Jerusalem1 site in 1 country30 target enrollmentApril 10, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Subjective Cognitive Decline (SCD)
Sponsor
Hebrew University of Jerusalem
Enrollment
30
Locations
1
Primary Endpoint
Memory Impact Questionnaire (MIQ)
Status
Recruiting
Last Updated
last year

Overview

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.
Registry
clinicaltrials.gov
Start Date
April 10, 2024
End Date
April 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adina Maeir

Prof. Adina Maeir, School of Occupational Therapy Hebrew University

Hebrew University of Jerusalem

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

Outcomes

Primary Outcomes

Memory Impact Questionnaire (MIQ)

Time Frame: After enrollment (before intervention) and 14 weeks later (after intervention)

The Memory Impact Questionnaire (MIQ) will be used to assess the impact of perceived memory changes on daily life. The questionnaire was developed for use in both clinical and research settings to better understand the impact of memory changes on the day-to-day functioning of older adults and to monitor outcomes of support programs for this population. The questionnaire includes 51-item comprised of three subscales: Lifestyle Restrictions (19 items exploring social relationships, work, volunteer and leisure activities), Positive Coping (19 items exploring participation in cognitively engaging tasks and other positive responses to memory changes), and Negative Emotions (13 items exploring negative self-perceptions and perceived negative judgments from others). The total score, calculated by reverse-coding Positive Coping items and summing all items, reflects the overall burden of memory changes, with higher scores indicating a greater negative impact.

Secondary Outcomes

  • Patient Health Questionnaire -4 (PHQ-4 )(After enrollment (before intervention) and 14 weeks later (after intervention))
  • SHARE version of the CASP-12(After enrollment (before intervention) and 14 weeks later (after intervention))
  • Engagement in Meaningful Activities Survey (EMAS)(After enrollment (before intervention) and 14 weeks later (after intervention))

Study Sites (1)

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