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Validation of the REMINDER Dementia Risk Reduction Program (REMINDER)

Primary Purpose

Healthy Aging, Risk Reduction, Old Age; Dementia

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
REMINDER
Brain health Psychoeducation
Sponsored by
University of Coimbra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy Aging

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 60 or older
  • CAIDE dementia risk score >8
  • Cognitive function: absence of significant cognitive impairment as per the Addenbrooke's Cognitive Examination-REVISED
  • Free of physical disabilities that preclude participation in the study
  • Willing to complete all study-related activities for 12 weeks

Exclusion Criteria:

  • Mild cognitive impairment or dementia;
  • Presence of any neurological event in their medical history that could compromise actual cognition.
  • Presence of any severe psychiatric disorder (mild depressive and anxiety symptoms meet inclusion criteria).
  • Unability to travel to the site where the sessions will be delivered (if so randomization will be circumscribed between the experimental harm REMINDER online and the control group.
  • Illiteracy

Sites / Locations

  • Faculty of Psychology and Educational SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

REMINDER program online

REMINDER program face-to-face

Brain psychoeducation program

Arm Description

The REMINDER program in this arm will be delivered by videoconferencing. It will integrate 20 sessions (with approximate length of 45-60 min), therapist-mediated, carried out twice a week, over a period of 12 weeks. Psychoeducation sessions and part of the reminiscence and memory strategies training sessions will be facilitated in groups, as means to promote social support and modeling, and the remaining will be individual sessions. Several activities aimed to promote personal development and definition and achievement of meaningful goals will be included in the program, and the program will be manualized to facilitate its future dissemination and implementation

The REMINDER program in this arm will be delivered face to face. It will integrate 20 sessions (with approximate length of 45-60 min), therapist-mediated, carried out twice a week, over a period of 12 weeks. Psychoeducation sessions and part of the reminiscence and memory strategies training sessions will be facilitated in groups, as means to promote social support and modeling, and the remaining will be individual sessions. Several activities aimed to promote personal development and definition and achievement of meaningful goals will be included in the program, and the program will be manualized to facilitate its future dissemination and implementation

The control condition will have the same length as the experimental harms, including 20 psychoeducation sessions, with information regarding dementia modifiable risk factors, information on healthy lifestyles, and brain health promotion.

Outcomes

Primary Outcome Measures

Cognitive status composite
A composite score including the individual scores with Addenbrooke's Cognitive Examination - Revised (ACE-R) (0-100, higher scores meaning better outcome), that includes the Mini Mental State Examination - MMSE (0-30, with higher scores meaning better outcome), Subjective Cognitive Decline Questionnaire (SCDQ), Trail Making Test A and B (TMT A & B), Verbal Fluency - Phonemic (P, M and R) and Categories (Animals), Stroop Test, Free and Cued Selective Reminding Test (FCSRT) will be generated to work as primary outcome.
Functionality status
A composite score incorporating Adults and Older Adults Functional Assessment Inventory (IAFAI), University of California San Diego Performance-Based Skills Assessment (UPSA) will be used.
Blood biomarkers of neural damage
blood Neurofilament light chain (NfL) will be measured and tested as an outcome immediately after the intervention
Cognitive status composite
A composite score including the individual scores with Addenbrooke's Cognitive Examination - Revised (ACE-R), that includes the Mini Mental State Examination - MMSE (screening tools to consider eligibility), Subjective Cognitive Decline Questionnaire (SCDQ), Trail Making Test A and B (TMT A & B), Verbal Fluency - Phonemic (P, M and R) and Categories (Animals), Stroop Test, Free and Cued Selective Reminding Test (FCSRT) will be generated to work as primary outcome
Functionality status
A composite score incorporating Adults and Older Adults Functional Assessment Inventory (IAFAI), University of California San Diego Performance-Based Skills Assessment (UPSA) will be used.
Cognitive status composite
A composite score including the individual scores with Addenbrooke's Cognitive Examination - Revised (ACE-R), that includes the Mini Mental State Examination - MMSE (screening tools to consider eligibility), Subjective Cognitive Decline Questionnaire (SCDQ), Trail Making Test A and B (TMT A & B), Verbal Fluency - Phonemic (P, M and R) and Categories (Animals), Stroop Test, Free and Cued Selective Reminding Test (FCSRT) will be generated to work as primary outcome
Functionality status
A composite score incorporating Adults and Older Adults Functional Assessment Inventory (IAFAI), University of California San Diego Performance-Based Skills Assessment (UPSA) will be used.

Secondary Outcome Measures

Brain changes
hippocampus volume and DMN connectivity will be measured pre and post intervention in the RCT phase
Mood status
The Geriatric Depression Scale Short Form (GDS-15) (0-15, with higher scores meaning worse outcomes) and and The Geriatric Anxiety Inventory- Short Form (GAI-SF, 0-5, with higher scores meaning worse outcome) scores will be measured
Mood status
The Geriatric Depression Scale Short Form (GDS-15) (0-15, with higher scores meaning worse outcomes) and and The Geriatric Anxiety Inventory- Short Form (GAI-SF, 0-5, with higher scores meaning worse outcome) scores will be measured.
Perceived quality of life
A measure of quality of life - World Health Organization Quality of Life - Old WHOQOL-OLD)will be incorporated to examine the effects of the program in self perceptions of well being. Higher scores mean better outcome
Perceived quality of life
A measure of quality of life - World Health Organization Quality of Life - Old WHOQOL-OLD)will be incorporated to examine the effects of the program in self perceptions of well being. Higher scores mean better outcome
Perceived Self Efficacy
A measure of self efficacy - Self Efficacy for Meaningful Activities (SEMActiv) will be implemented to examine self-efficacy, with higher scores meaning better outcome
Perceived Self Efficacy
A measure of self efficacy - Self Efficacy for Meaningful Activities (SEMActiv) will be implemented to examine self-efficacy, with higher scores meaning better outcome

Full Information

First Posted
February 22, 2022
Last Updated
May 8, 2023
Sponsor
University of Coimbra
Collaborators
Fundação para a Ciência e a Tecnologia
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1. Study Identification

Unique Protocol Identification Number
NCT05296980
Brief Title
Validation of the REMINDER Dementia Risk Reduction Program
Acronym
REMINDER
Official Title
Validation of a Multidomain Neuropsychological Intervention for Individuals at Risk of Dementia: the REMINDER Program
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Coimbra
Collaborators
Fundação para a Ciência e a Tecnologia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Until now, neuropsychological interventions aimed to optimize cognitive function and to have functional impact in individuals at risk of AD (MCI patients) were scarce in validity studies. While some RCTs have been developed in cognitive training interventions, comparative studies of merged interventions (cognitive, social and behavioral stimulation) with adequate control groups are absent, diminishing the professionals' trust on the adoption of these interventions for supporting patients. As such, the present proposal will develop a validation trial testing a multicomponent neuropsychological intervention (REMINDER), based on personal development, cognitive compensatory aids, meaningful goals setting, and behavior change techniques. The investigators will analyze its short/long-term gains and AD conversion rates. By aiming to provide a good validation study for REMINDER, the investigators will examine neurobiological, neurocognitive and functional outcomes of this intervention in comparison with an active control group (psychoeducation) in order to foster an effective outcome assessment of an intervention for individuals at risk of AD.
Detailed Description
The overarching tenet of this project is that, by providing a manualized multidomain intervention - REMINDER - that engages at risk individuals in the aims of this protocol, it can have a significant impact on health outcomes, optimizing healthier lifestyles and these being also understood along with the neurodegeneration signs of this impact. The specific aims of this study will be: Recruit community-dwelling individuals with increased risk of dementia using CAIDE dementia risk score (with APOE, when available). Evaluate the REMINDER program (in comparison to an active control group (CT) - psychoeducation sessions) immediate effects regarding global cognition and functionality (primary outcomes) and neuropsychological, biochemical and neuroimaging outcomes (secondary outcomes). Determine the persistence of effects and begin characterizing the temporal course of putative benefits at 6-, and 18-months follow-up. Investigate the role of biomarkers (imaging and biochemical) in explaining the response to intervention and persistence of the effects and its correlation with neuropsychological and functionality measures. Measure the conversion rates from MCI to AD between the REMINDER and active control groups (at 24- months follow-up). Our ultimate goal is to make available a scientifically validated and scalable intervention that helps prevent dementia in older adults at risk. By confirming the efficacy of REMINDER to prevent cognitive impairment and concluding for its medium-term efficacy to improve global cognitive function and healthy life habits the investigators are contributing to one of the WHO goals (Goal 3 - ensure healthy lives and promote well-being for all at all ages) by addressing risk reduction and management of a global health risk.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Aging, Risk Reduction, Old Age; Dementia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
REMINDER program online
Arm Type
Experimental
Arm Description
The REMINDER program in this arm will be delivered by videoconferencing. It will integrate 20 sessions (with approximate length of 45-60 min), therapist-mediated, carried out twice a week, over a period of 12 weeks. Psychoeducation sessions and part of the reminiscence and memory strategies training sessions will be facilitated in groups, as means to promote social support and modeling, and the remaining will be individual sessions. Several activities aimed to promote personal development and definition and achievement of meaningful goals will be included in the program, and the program will be manualized to facilitate its future dissemination and implementation
Arm Title
REMINDER program face-to-face
Arm Type
Experimental
Arm Description
The REMINDER program in this arm will be delivered face to face. It will integrate 20 sessions (with approximate length of 45-60 min), therapist-mediated, carried out twice a week, over a period of 12 weeks. Psychoeducation sessions and part of the reminiscence and memory strategies training sessions will be facilitated in groups, as means to promote social support and modeling, and the remaining will be individual sessions. Several activities aimed to promote personal development and definition and achievement of meaningful goals will be included in the program, and the program will be manualized to facilitate its future dissemination and implementation
Arm Title
Brain psychoeducation program
Arm Type
Sham Comparator
Arm Description
The control condition will have the same length as the experimental harms, including 20 psychoeducation sessions, with information regarding dementia modifiable risk factors, information on healthy lifestyles, and brain health promotion.
Intervention Type
Behavioral
Intervention Name(s)
REMINDER
Intervention Description
The REMINDER program is a therapist-mediated manualized neuropsychological intervention, involving training skills to stimulate cognitive reserve, socialization and personal development, to diminish the risk of cognitive decline.
Intervention Type
Behavioral
Intervention Name(s)
Brain health Psychoeducation
Intervention Description
Delivery of psychoeducation sessions about dementia modifiable risk factors, brain health solutions and lifestyle change tips.
Primary Outcome Measure Information:
Title
Cognitive status composite
Description
A composite score including the individual scores with Addenbrooke's Cognitive Examination - Revised (ACE-R) (0-100, higher scores meaning better outcome), that includes the Mini Mental State Examination - MMSE (0-30, with higher scores meaning better outcome), Subjective Cognitive Decline Questionnaire (SCDQ), Trail Making Test A and B (TMT A & B), Verbal Fluency - Phonemic (P, M and R) and Categories (Animals), Stroop Test, Free and Cued Selective Reminding Test (FCSRT) will be generated to work as primary outcome.
Time Frame
Post intervention (1 week after the intervention sessions completion)
Title
Functionality status
Description
A composite score incorporating Adults and Older Adults Functional Assessment Inventory (IAFAI), University of California San Diego Performance-Based Skills Assessment (UPSA) will be used.
Time Frame
Post intervention (1 week after the intervention sessions completion)
Title
Blood biomarkers of neural damage
Description
blood Neurofilament light chain (NfL) will be measured and tested as an outcome immediately after the intervention
Time Frame
Post intervention (1 week after the intervention sessions completion)
Title
Cognitive status composite
Description
A composite score including the individual scores with Addenbrooke's Cognitive Examination - Revised (ACE-R), that includes the Mini Mental State Examination - MMSE (screening tools to consider eligibility), Subjective Cognitive Decline Questionnaire (SCDQ), Trail Making Test A and B (TMT A & B), Verbal Fluency - Phonemic (P, M and R) and Categories (Animals), Stroop Test, Free and Cued Selective Reminding Test (FCSRT) will be generated to work as primary outcome
Time Frame
Follow - up (12 months after the intervention)
Title
Functionality status
Description
A composite score incorporating Adults and Older Adults Functional Assessment Inventory (IAFAI), University of California San Diego Performance-Based Skills Assessment (UPSA) will be used.
Time Frame
Follow - up (12 months after the intervention)
Title
Cognitive status composite
Description
A composite score including the individual scores with Addenbrooke's Cognitive Examination - Revised (ACE-R), that includes the Mini Mental State Examination - MMSE (screening tools to consider eligibility), Subjective Cognitive Decline Questionnaire (SCDQ), Trail Making Test A and B (TMT A & B), Verbal Fluency - Phonemic (P, M and R) and Categories (Animals), Stroop Test, Free and Cued Selective Reminding Test (FCSRT) will be generated to work as primary outcome
Time Frame
Follow - up (24 months after the intervention)
Title
Functionality status
Description
A composite score incorporating Adults and Older Adults Functional Assessment Inventory (IAFAI), University of California San Diego Performance-Based Skills Assessment (UPSA) will be used.
Time Frame
Follow - up (24 months after the intervention)
Secondary Outcome Measure Information:
Title
Brain changes
Description
hippocampus volume and DMN connectivity will be measured pre and post intervention in the RCT phase
Time Frame
Post intervention (2 weeks after the intervention sessions completion)
Title
Mood status
Description
The Geriatric Depression Scale Short Form (GDS-15) (0-15, with higher scores meaning worse outcomes) and and The Geriatric Anxiety Inventory- Short Form (GAI-SF, 0-5, with higher scores meaning worse outcome) scores will be measured
Time Frame
Post intervention (1 week after the intervention sessions completion)
Title
Mood status
Description
The Geriatric Depression Scale Short Form (GDS-15) (0-15, with higher scores meaning worse outcomes) and and The Geriatric Anxiety Inventory- Short Form (GAI-SF, 0-5, with higher scores meaning worse outcome) scores will be measured.
Time Frame
Follow-up (12 months after the intervention)
Title
Perceived quality of life
Description
A measure of quality of life - World Health Organization Quality of Life - Old WHOQOL-OLD)will be incorporated to examine the effects of the program in self perceptions of well being. Higher scores mean better outcome
Time Frame
Post intervention (1 week after the intervention sessions completion)
Title
Perceived quality of life
Description
A measure of quality of life - World Health Organization Quality of Life - Old WHOQOL-OLD)will be incorporated to examine the effects of the program in self perceptions of well being. Higher scores mean better outcome
Time Frame
Follow-up (12 months after the intervention)
Title
Perceived Self Efficacy
Description
A measure of self efficacy - Self Efficacy for Meaningful Activities (SEMActiv) will be implemented to examine self-efficacy, with higher scores meaning better outcome
Time Frame
Post intervention (1 week after the intervention sessions completion)
Title
Perceived Self Efficacy
Description
A measure of self efficacy - Self Efficacy for Meaningful Activities (SEMActiv) will be implemented to examine self-efficacy, with higher scores meaning better outcome
Time Frame
Follow-up (12 months after the intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 60 or older CAIDE dementia risk score >8 Cognitive function: absence of significant cognitive impairment as per the Addenbrooke's Cognitive Examination-REVISED Free of physical disabilities that preclude participation in the study Willing to complete all study-related activities for 12 weeks Exclusion Criteria: Mild cognitive impairment or dementia; Presence of any neurological event in their medical history that could compromise actual cognition. Presence of any severe psychiatric disorder (mild depressive and anxiety symptoms meet inclusion criteria). Unability to travel to the site where the sessions will be delivered (if so randomization will be circumscribed between the experimental harm REMINDER online and the control group. Illiteracy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Rita Silva, PhD
Phone
+351962779695
Email
anaritaess@fpce.uc.pt
First Name & Middle Initial & Last Name or Official Title & Degree
University of Coimbra
Phone
+351 239851450
Email
cineicc@fpce.uc.pt
Facility Information:
Facility Name
Faculty of Psychology and Educational Sciences
City
Coimbra
ZIP/Postal Code
3002-115
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FPCEUC
Phone
00351239 851 450
Email
cineicc@fpce.uc.pt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Open science plans will involve the sharing of IPD with other researchers, clearly anonymized in order to promote the studies replication. We are still building our plan for data sharing and we will update as soon as it is defined.

Learn more about this trial

Validation of the REMINDER Dementia Risk Reduction Program

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