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

NCT06632145 | Recruiting

• 1 other identifier: 04042023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Is the intervention feasible in terms of fidelity, adherence, and participant satisfaction?
2. 2.Are the assessments used sensitive enough to identify the unique challenges faced by the SCD population and detect changes after the intervention?
3. 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?
4. 4.Take part in 14 weekly group sessions focused on managing the challenges of living with SCD and improving participation in daily activities.
5. 5.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.

Conditions

Subjective Cognitive Decline (SCD)

Keywords

Occupational experience; Participation; Cognitive functional interventions; Functional decline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Arms (1)

Cog Fun Ageing intervention

EXPERIMENTAL

Other: Cog Fun Ageing intervention

Interventions

Cog Fun Ageing intervention OTHER

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.

Cog Fun Ageing intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hebrew University of Jerusalem: lead

Study Sites (1)

Hebrew University of Jerusalem

Jerusalem, Israel

RECRUITING

Related Publications (2)

• 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.

  PMID: 34268448 BACKGROUND

• 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.

  PMID: 33989108 BACKGROUND

Study Officials

• Adina Maeir, PhD

  School of occupational therapy, faculty of medicine, Hebrew University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adina Maeir, PhD

CONTACT

972-546-205081; adina.maeir@mail.huji.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Adina Maeir, School of Occupational Therapy Hebrew University

Model Details: Pre post pilot feasibility study

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 8, 2024
• Study Start: April 10, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

IL (1)