Feasibility and Preliminary Efficacy of a 12-weeks Digital Environmental Enrichment Intervention in Cognitively Unimpaired Older Adults (REMINDer)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- German Center for Neurodegenerative Diseases (DZNE)
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Effectiveness: Change in overall mental and physical well-being
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Miranka Wirth
Dr. habil. Dipl.-Psych.
German Center for Neurodegenerative Diseases (DZNE)
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)
Outcomes
Primary Outcomes
Effectiveness: Change in overall mental and physical well-being
Time Frame: from baseline (t1) to the end of the 6-weeks intervention (t2)
Assessed by the Short-Form-Health Survey (SF-12), range 0 to 100, higher scores indicate greater mental and physical well-being.
Feasibility: Adherence to the intervention
Time Frame: from baseline (t1) to the end of the 6-weeks intervention (t2)
Assessed by the number of sessions attended in relation to the total number of sessions (\[number of sessions attended / total number of sessions\] \* 100).
Secondary Outcomes
- Feasibility: dropout rate(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))
- Change in sensory ability: interoceptive awareness(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))
- Change in negative emotion: perceived stress(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))
- Feasibility: reach(End of 6-week-intervention (t2))
- Change in well-being: psychological well-being(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))
- Change in positive emotion: life-satisfaction(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))
- Change in negative emotion: anxiety(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))
- Change in lifestyle: sleep quality(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))
- Feasibility: retention rate(12 weeks post baseline (6 weeks post intervention) (t3))
- Feasibility: Change in credibility and acceptance(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))
- Change in cognitive ability: objective cognitive function(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))
- Change in sensory ability: self-perceived bodily abilities(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))
- Change in cognitive ability: subjective cognition function(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))
- Change in positive emotion: mindfulness(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))
- Change in social connectedness with others(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))
- Change in lifestyle: physical activity(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))
- Change in motor ability: frailty(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))
- Change in well-being: general well-being(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))
- Change in social integration / loneliness(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))
- Change in lifestyle: social activity(a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3))