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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Subjective Cognitive Decline (SCD)
• Intervention / Treatment: Other: Cog Fun Ageing intervention

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adina Maeir, PhD; Phone Number: 972-546-205081; Email: adina.maeir@mail.huji.ac.il

Study Locations

• Israel
  • Jerusalem, Israel
    • Recruiting
    • Hebrew University of Jerusalem
    • Contact: Adina Maeir, PhD; Phone Number: 972-546-205-081; Email: Adina.maeir@mail.huji.ac.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cog Fun Ageing intervention

Other: Cog Fun Ageing intervention; Cog Fun Ageing is a group-based occupation-centered intervention aimed at promoting positive occupational experiences despite cognitive challenges in day to day life. The intervention includes 14 weekly 120-minute group sessions led by experienced occupational therapists. Sessions incorporate learning about the bio-psycho-social factors of SCD and strategies to manage and cope with occupational challenges resulting from SCD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Memory Impact Questionnaire (MIQ)	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.	After enrollment (before intervention) and 14 weeks later (after intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire -4 (PHQ-4 )	The Patient Health Questionnaire-4 (PHQ-4) is a brief, self-report screening tool designed to quickly assess symptoms of depression and anxiety in the general population. It includes four questions, with two focused on anxiety and two on depression. The PHQ-4 combines two well-established scales: the PHQ-2 (depression) and the GAD-2 (anxiety). Participants respond to each question based on how often they have experienced certain symptoms over the past two weeks, using a 4-point Likert scale from 0 = Not at all to 3 = Nearly every day. The total score ranges from 0 to 12, with subscale scores ranging from 0 to 6 for both anxiety and depression. Scores are rated as: 0-2- Normal; 3-5 -Mild; 6-8- Moderate; 9-12- Severe. Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression.	After enrollment (before intervention) and 14 weeks later (after intervention)
SHARE version of the CASP-12	The CASP-12 (Control, Autonomy, Self-realization, and Pleasure) is a self-report questionnaire designed to measure the quality of life (QoL) in older adults, specifically targeting individuals aged 50 and over. The CASP-12 includes 12 items spread across four dimensions: control (the ability to influence one's environment), autonomy (freedom from external influence), self-realization (personal fulfillment), and pleasure (enjoyment in life). Participants rate each item on a 4-point Likert scale, ranging from 1 (often) to 4 (never), with higher scores indicating a higher quality of life. The total score can range from 12 to 48, where higher scores suggest greater well-being and satisfaction in the participants' lives.	After enrollment (before intervention) and 14 weeks later (after intervention)
Engagement in Meaningful Activities Survey (EMAS)	The Engagement in Meaningful Activities Survey (EMAS) is a 12-item self-report questionnaire used to assess how meaningful a person's daily activities are. The survey asks participants to rate statements like "The activities I do give me a sense of satisfaction"; or "The activities I do help me feel competent," using a 4-point scale where 1 means "rarely"; and 4 means "always". The total score ranges from 12 to 48, with higher scores indicating higher levels of engagement in meaningful activities. This tool is used to measure changes in how participants perceive the value and meaning of their activities. The EMAS helps identify whether interventions improve participants' sense of purpose and satisfaction in their daily lives.	After enrollment (before intervention) and 14 weeks later (after intervention)

Collaborators and Investigators

• Sponsor: Hebrew University of Jerusalem
• Investigators: Principal Investigator: Adina Maeir, PhD, School of occupational therapy, faculty of medicine, Hebrew University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: October 6, 2024
• First Submitted That Met QC Criteria: October 6, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Functional decline; Participation; Occupational experience; Cognitive functional interventions
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 04042023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Due to the preliminary nature of the study, the outcome measures are still being evaluated for their suitability for interventions for the target population.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No