Clinical trial NCT06530277: REMINDer - A Digital Environmental Enrichment Intervention
Official title: Feasibility and Preliminary Efficacy of a 12-weeks Digital Environmental Enrichment Intervention in Cognitively Unimpaired Older Adults (REMINDer)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Feasibility
Adherence
Prevention
Aging
Alzheimer's disease
Dance
Dance-movement therapy
Lifestyle
Well-being
Quality-of-life
Lead sponsor: German Center for Neurodegenerative Diseases (DZNE)
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 58
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The intervention will be compared to a 6-week passive control (waitlist with delayed intervention, AB-BA design) in a cross-over study design.
Primary purpose: OTHER

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 Alzheimer's disease, are considered a global challenge for society. Multiple physical, cognitive, and psychosocial risk factors can increase the risk of developing Alzheimer's 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 1:1 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, emotional/affective, 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 Alzheimer's disease.

Eligibility criteria: Inclusion Criteria:

* Retired adults aged between 60 and 80 years
* Fluency in the German language
* Cognitively unimpaired, as assessed via the Six-Item Screener (SIS) ≥ 4 points (out of 6)
* Access to wireless internet connection and a digital device with speakers, screen, and camera at home
* Access to a personal email address
* Sufficient in-home space
* Availability throughout the study and its measurement time points
* Ability to provide written informed consent
* Spouses (must be in the same group and each participate in the intervention individually via their own device and in independent rooms; this fact is considered accordingly in the analyses)

Exclusion Criteria:

* Regular rigorous physical exercise as defined by regular aerobic exercise (\> 1.5 hours/week) during the last 6 months
* Regular prior experience (\> 1 hour/week) with tai chi, dance-movement, or other mind-body practices during the last 6 months
* Disabilities that limit participation in online moment programs: Presence of physical ineligibility or mobility restrictions through a history of falls, not being able to walk, reliance on a walking aid
* Severe uncorrected auditory or visual impairments that limit the ability to listen to online instructions or to observe online movements
* Diagnosis of cognitive impairment and any type of dementia
* Diagnosis of motor disorders (e.g. Parkinson's disease, multiple sclerosis)
* History of cerebral disease (e.g. tumor)
* Severe neurological disorders (e.g. epilepsy)
* Diagnosis of psychiatric disorders (e.g. depression)
* Other chronic medical disorders that limit physical activity (e.g. advanced cardiac or respiratory disease, severe hypertension)
* Substance abuse (excessive smoking, alcohol consumption, drug abuse)
* Current participation in another research study

Primary outcomes:
measure: Feasibility: Adherence to the intervention
timeFrame: from baseline (t1) to the end of the 6-weeks intervention (t2)
measure: Effectiveness: Change in overall mental and physical well-being
timeFrame: from baseline (t1) to the end of the 6-weeks intervention (t2)
Secondary outcomes:
measure: Feasibility: reach
timeFrame: End of 6-week-intervention (t2)
measure: Feasibility: retention rate
timeFrame: 12 weeks post baseline (6 weeks post intervention) (t3)
measure: Feasibility: dropout rate
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
measure: Feasibility: Change in credibility and acceptance
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
measure: Change in cognitive ability: subjective cognition function
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
measure: Change in cognitive ability: objective cognitive function
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
measure: Change in motor ability: frailty
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
measure: Change in sensory ability: interoceptive awareness
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
measure: Change in sensory ability: self-perceived bodily abilities
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
measure: Change in well-being: psychological well-being
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
measure: Change in well-being: general well-being
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
measure: Change in positive emotion: life-satisfaction
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
measure: Change in positive emotion: mindfulness
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
measure: Change in negative emotion: perceived stress
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
measure: Change in negative emotion: anxiety
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
measure: Change in social integration / loneliness
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
measure: Change in social connectedness with others
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
measure: Change in lifestyle: social activity
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
measure: Change in lifestyle: physical activity
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
measure: Change in lifestyle: sleep quality
timeFrame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: German Center for Neurodegenerative Diseases (DZNE), Dresden
state: Saxony
Study officials:
affiliation: German Center for Neurodegenerative Diseases (DZNE), Dresden
name: Miranka Wirth, Dr. habil. Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
affiliation: German Center for Neurodegenerative Diseases (DZNE), Dresden
name: Olga M. Klimecki, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: