Testing the Cog-Fun Aging Program for Older Adults With Subjective Cognitive Decline

NCT ID: NCT06816797

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-20

Study Completion Date

2025-08-31

Brief Summary

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The goal of this clinical trial is to learn if the Cog-Fun Aging program helps older adults with Subjective Cognitive Decline (SCD) manage memory challenges and improve their daily lives. The main questions it aims to answer are:

* Does the program help participants better understand their cognitive challenges in daily life?
* Do participants report using more effective strategies to manage their memory difficulties?
* Does the Cog-Fun Aging program reduce negative emotions and self-perceptions related to SCD?

Researchers will compare participants who complete the Cog-Fun Aging program with those who do not to determine the program's effectiveness.

Participants will:

Take part in a 10-week program with weekly sessions. Learn about SCD and how it affects daily life. Practice and monitor strategies to manage memory difficulties.

Detailed Description

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Conditions

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Subjective Cognitive Decline (SCD) Subjective Cognitive Impairment Subjective Memory Complaints

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Participants will be recruited from three centers. Each center will form a homogenous group for the Cog-Fun Aging intervention. One center will include both an intervention group and a control group with a crossover component.

At this center, participants in the intervention group will begin the 10-week Cog-Fun Aging program after an initial baseline assessment (T0). The control group will also be assessed at T0 but will not receive the intervention during this initial phase. Both groups will undergo a second assessment (T1) after the intervention group completes the program to evaluate changes. Following T1, the control group will participate in the intervention and undergo a final assessment (T2) to evaluate the effects of the intervention in the crossover phase. This design allows for comparison between the intervention and control groups, as well as evaluation of outcomes after the crossover phase.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Crossover control group

Participants in the control arm will not receive the Cog-Fun Aging intervention during the initial phase (10 weeks). Instead, they will undergo baseline assessments (T0) alongside the intervention group. After the first group completes the 10-week program, the control arm participants will be assessed again (T1). They will then begin the 10-week Cog-Fun Aging intervention and complete a final assessment (T2) after the intervention to evaluate its effects.

Group Type EXPERIMENTAL

Cog-Fun Aging Crossover

Intervention Type OTHER

In the initial phase of the study (between T0 and T1) this group will receive "usual care". Participants are users of regional services where activities for healthy older adults are available. This group will continue going to activities as normal during the initial phase and then participate in the Cog-Fun Aging intervention.

Cog-Fun aging intervention

Group Type EXPERIMENTAL

Cog Fun Ageing intervention

Intervention Type OTHER

Cog Fun Aging is a group-based intervention aimed at promoting positive occupational experiences despite cognitive challenges in day to day life. The intervention includes 10 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.

Interventions

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Cog Fun Ageing intervention

Cog Fun Aging is a group-based intervention aimed at promoting positive occupational experiences despite cognitive challenges in day to day life. The intervention includes 10 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.

Intervention Type OTHER

Cog-Fun Aging Crossover

In the initial phase of the study (between T0 and T1) this group will receive "usual care". Participants are users of regional services where activities for healthy older adults are available. This group will continue going to activities as normal during the initial phase and then participate in the Cog-Fun Aging intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* experiencing memory changes and feeling concerned about them
* a score of 23 or higher on the MoCA (Montreal Cognitive Assessment)
* ability to speak and understand Hebrew sufficiently to participate in a Hebrew-speaking group

Exclusion Criteria

* a self-reported health condition that significantly impacts functioning (e.g., uncontrolled diabetes, severe heart/lung disease)
* residing in a medical institution or nursing home
* currently participating in another SCD treatment
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Israel

OTHER_GOV

Sponsor Role collaborator

Hebrew University of Jerusalem

OTHER

Sponsor Role lead

Responsible Party

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Adina Maeir

Professor Adina Maeir

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adina Maeir, PhD

Role: PRINCIPAL_INVESTIGATOR

School of occupational therapy, faculty of medicine, Hebrew University

Locations

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Hebrew University of Jerusalem

Jerusalem, , Israel

Site Status ACTIVE_NOT_RECRUITING

Merhavim Misgav

Misgav Regional Council, , Israel

Site Status ACTIVE_NOT_RECRUITING

Hadarim College

Sde Warburg, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Adina Maeir, PhD

Role: CONTACT

972-546-205081

Facility Contacts

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Rinat Wasserman

Role: primary

972-9-7481844

References

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Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613.

Reference Type BACKGROUND
PMID: 19996233 (View on PubMed)

Ownsworth TL, McFarland KM, Young RM. Development and standardization of the Self-regulation Skills Interview (SRSI): a new clinical assessment tool for acquired brain injury. Clin Neuropsychol. 2000 Feb;14(1):76-92. doi: 10.1076/1385-4046(200002)14:1;1-8;FT076.

Reference Type BACKGROUND
PMID: 10855062 (View on PubMed)

Troyer AK, Shaikh KT, Baptist-Mohseni N, Singh A, Duncan-Kofman J, Vandermorris S, Rich JB. Creation and Validation of the MMQ-9: A Short Version of the Multifactorial Memory Questionnaire for Middle-Aged and Older Adults. Clin Gerontol. 2025 May-Jun;48(3):528-538. doi: 10.1080/07317115.2024.2421876. Epub 2024 Oct 29.

Reference Type BACKGROUND
PMID: 39473141 (View on PubMed)

Shaikh KT, Tatham EL, Parikh PK, McCreath GA, Rich JB, Troyer AK. Development and Psychometric Validation of a Questionnaire Assessing the Impact of Memory Changes in Older Adults. Gerontologist. 2019 Jul 16;59(4):e248-e257. doi: 10.1093/geront/gny011.

Reference Type BACKGROUND
PMID: 29522122 (View on PubMed)

Other Identifiers

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20112024

Identifier Type: -

Identifier Source: org_study_id

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