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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
58
REMINDer adapts the REMIND program (Nicotra et al., 2022) for telehealth, integrating cognitive, motor, sensory, emotional, and social stimulation through "music, dance-based movement, and mindfulness". The program consists of 2 online sessions/week for 60 minutes each over 6 weeks, led by trained facilitators experienced in dance movement therapy and mindfulness exercises. Sessions are divided into welcome/warm-up (10 min), training (40 min), and relaxation/feedback (10 min) phases. Using a structured manual, participants perform exercises that address the program's multimodal stimulation. The REMINDer program is delivered in a group setting via an online videoconferencing system. The "intervention, no intervention" (AB) group undergoes the training program between t1 and t2 and then resumes their normal lifestyle from t2 to t3. The "no intervention, intervention" group (BA) maintains its normal lifestyle from t1 to t2 and then participates in the training program from t2 to t3.
German Center for Neurodegenerative Diseases (DZNE), Dresden
Dresden, Saxony, Germany
Feasibility: Adherence to the intervention
Assessed by the number of sessions attended in relation to the total number of sessions (\[number of sessions attended / total number of sessions\] \* 100).
Time frame: from baseline (t1) to the end of the 6-weeks intervention (t2)
Effectiveness: Change in overall mental and physical well-being
Assessed by the Short-Form-Health Survey (SF-12), range 0 to 100, higher scores indicate greater mental and physical well-being.
Time frame: from baseline (t1) to the end of the 6-weeks intervention (t2)
Feasibility: reach
\[participants enrolled / participants screened and eligible\] \* 100
Time frame: End of 6-week-intervention (t2)
Feasibility: retention rate
\[participants completing t3 / participants enrolled\] \* 100
Time frame: 12 weeks post baseline (6 weeks post intervention) (t3)
Feasibility: dropout rate
Assessed by the number of participants who did not complete the intervention and follow-up period divided by the total number of participants that underwent the randomisation process.
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Feasibility: Change in credibility and acceptance
Assessed by the Credibility Expectancy Questionnaire (CEQ), instruction adapted, range 1 to 9, higher scores indicating higher credibility and acceptance
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
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Change in cognitive ability: subjective cognition function
Assessed by the Everyday Cognition Scales (ECog-12), short form, instruction adapted, range 1 to 4 (mean), higher scores indicate higher subjective cognitive impairment / worse cognitive state
Time frame: 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
Assessed by the Consortium to Establish a Registry for Alzheimer's Disease (CERAD): word list learning. Instruction adapted, range subscale wordlist learning 0 to 10, higher scores indicate better memory function
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in motor ability: frailty
Assessed by the Tilburg frailty indicator (TFI), range 0 to 15, higher scores indicate higher frailty.
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in sensory ability: interoceptive awareness
Assessed by the Multidimensional Assessment of Interoceptive Awareness (MAIA), subscale awareness, range 0 to 5, higher scores indicate more positive body awareness
Time frame: 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
Assessed by the Body Self-Efficacy Scale (BSE), range 1 to 5, higher scores indicate greater feelings associated with the four domains: guilt, shame, authentic pride and hubristic pride
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in well-being: psychological well-being
Assessed by the Ryff's Psychological Well-Being Scales (PWB), short form (18 items), range 1 to 7, higher scores indicate greater well-being.
Time frame: 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
Assessed by the Heidelberg State Inventory (HSI-24), range 1 to 5, higher scores indicate higher well-being
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in positive emotion: life-satisfaction
Assessed by the General Life Satisfaction Short Scale (L1), range 0 to 10, higher scores indicate greater satisfaction with life
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in positive emotion: mindfulness
Assessed by the Freiburg Mindfulness Inventory (German: FFA), range 1 to 4, higher scores indicate more mindfulness
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in negative emotion: perceived stress
Assessed by the Perceived Stress Scale (PSS-10), range 1 to 5, higher scores indicate greater levels of perceived stress
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in negative emotion: anxiety
Assessed by the State-Trait Anxiety Inventory (STAI-5), short form, range 1 to 4, higher scores indicate higher anxiety
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in social integration / loneliness
Assessed by the German Version of the UCLA Three-item loneliness scale (LS-S), range 1 to 5, higher scores indicate less social integration / more loneliness
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in social connectedness with others
Assessed by the Inclusion of Other in the Self (IOS), range 1 to 7, higher scores indicate more overlap indicating higher social connectedness
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in lifestyle: social activity
Assessed by the Lubben Social Network Scale (LSNS-6), range 0 to 30, higher scores indicate bigger active and intimate networks of family and friends
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in lifestyle: physical activity
Assessed by the Physical Activity Scale for the Elderly (PASE), minimum score 0, higher scores indicate greater physical activity
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in lifestyle: sleep quality
Assessed by the Jenkins Sleep Scale 4 (JSS-4), range 0 to 20, higher scores indicate more sleep problems
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)