Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530277
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-27
Brief Title:
REMINDer - A Digital Environmental Enrichment Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility and Preliminary Efficacy of a 12-weeks Digital Environmental Enrichment Intervention in Cognitively Unimpaired Older Adults REMINDer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMINDer
Brief Summary:
The primary goal of this pilot study is to assess the feasibility and effectiveness for improving overall mental and physical well-being of a multimodal intervention program in older adults carried out in a digital telehealth setting
Detailed Description:
Background Increasing life expectancy and associated age-related diseases such as Alzheimers disease are considered a global challenge for society Multiple physical cognitive and psychosocial risk factors can increase the risk of developing Alzheimers disease To effectively maintain mental health and well-being in older adults multimodal low-threshold cost-effective lifestyle-based intervention strategies that simultaneously and sustainably promote cognitive physical psychological and social functioning in the older population are needed
Objective The primary objective of this randomized controlled pilot study is to assess the feasibility and effectiveness of a multimodal intervention program delivered in a digital telehealth environment to improve overall mental and physical well-being of older adults
Methods The REMINDer study is a monocentric randomized assessor-blinded controlled pilot study with a 6-week intervention period 2 hours per week The study includes a digital multimodal intervention called REMINDer Environmental Enrichment Intervention to Prevent Dementia - electronic intervention This program is specifically designed for older adults and includes music dance-based movement and mind specifically mindfulness activities that are simultaneously trained to activate and strengthen brain resources and resilience to dementia The intervention will be delivered in a digital telehealth environment via an established videoconferencing platform and compared to a 6-week passive control waitlist with delayed intervention AB-BA design in a cross-over study design For this first pilot study a total of n 50 cognitively unimpaired older adults will be recruited from the general population spouses will be allowed in the same group and analyses will be controlled accordingly Participants will be randomized to the two intervention groups using block randomization stratified by age and sex with a 11 allocation ratio
Results The primary outcomes of the study are feasibility operationalized by adherence rates and effectiveness of the intervention Adherence per participant will be assessed by the number of sessions attended relative to the total number of sessions Effectiveness will be assessed by the change in self-reported overall mental and physical well-being operationalized by the Short-Form Health Survey SF-12 measured at baseline t1 post-intervention t2 and follow-up t3 Secondary outcomes will include changes in self-reported cognitive motor sensory emotionalaffective social and lifestyle behaviors assessed at baseline post-intervention and follow-up using digital assessments
Discussion This pilot study will provide preliminary evidence on the feasibility and effectiveness of a digital multimodal intervention REMINDer to improve mental health and well-being in older adults The results of this pilot study will inform a larger intervention trial aimed at improving multiple health risk factors for dementia in older populations at increased risk for Alzheimers disease
Objective The primary objective of this randomized controlled pilot study is to assess the feasibility and effectiveness of a multimodal intervention program delivered in a digital telehealth environment to improve overall mental and physical well-being of older adults
Methods The REMINDer study is a monocentric randomized assessor-blinded controlled pilot study with a 6-week intervention period 2 hours per week The study includes a digital multimodal intervention called REMINDer Environmental Enrichment Intervention to Prevent Dementia - electronic intervention This program is specifically designed for older adults and includes music dance-based movement and mind specifically mindfulness activities that are simultaneously trained to activate and strengthen brain resources and resilience to dementia The intervention will be delivered in a digital telehealth environment via an established videoconferencing platform and compared to a 6-week passive control waitlist with delayed intervention AB-BA design in a cross-over study design For this first pilot study a total of n 50 cognitively unimpaired older adults will be recruited from the general population spouses will be allowed in the same group and analyses will be controlled accordingly Participants will be randomized to the two intervention groups using block randomization stratified by age and sex with a 11 allocation ratio
Results The primary outcomes of the study are feasibility operationalized by adherence rates and effectiveness of the intervention Adherence per participant will be assessed by the number of sessions attended relative to the total number of sessions Effectiveness will be assessed by the change in self-reported overall mental and physical well-being operationalized by the Short-Form Health Survey SF-12 measured at baseline t1 post-intervention t2 and follow-up t3 Secondary outcomes will include changes in self-reported cognitive motor sensory emotionalaffective social and lifestyle behaviors assessed at baseline post-intervention and follow-up using digital assessments
Discussion This pilot study will provide preliminary evidence on the feasibility and effectiveness of a digital multimodal intervention REMINDer to improve mental health and well-being in older adults The results of this pilot study will inform a larger intervention trial aimed at improving multiple health risk factors for dementia in older populations at increased risk for Alzheimers disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None