REMINDer - a Digital Environmental Enrichment Intervention (REMINDer)

Feasibility and Preliminary Efficacy of a 12-weeks Digital Environmental Enrichment Intervention in Cognitively Unimpaired Older Adults (REMINDer)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: REMINDer (A digital environmental enrichment intervention)

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • German Center for Neurodegenerative Diseases (DZNE), Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention, no intervention (AB); Beginning with the digital multimodal intervention (REMINDer) and then transitioning to a no intervention phase (sequence: AB).	Behavioral: REMINDer (A digital environmental enrichment intervention); 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.
Experimental: No intervention, intervention (BA); Starting with a no intervention phase and subsequently moving to the digital multimodal intervention (REMINDer) (sequence: BA).	Behavioral: REMINDer (A digital environmental enrichment intervention); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	from baseline (t1) to the end of the 6-weeks intervention (t2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: reach	[participants enrolled / participants screened and eligible] * 100	End of 6-week-intervention (t2)
Feasibility: retention rate	[participants completing t3 / participants enrolled] * 100	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.	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	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	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	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	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.	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	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	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.	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	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	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	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	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	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	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	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	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	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	a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)

Collaborators and Investigators

• Sponsor: German Center for Neurodegenerative Diseases (DZNE)
• Collaborators: Principal Investigator: PD Dr. Olga Klimecki-Lenz
• Investigators: Principal Investigator: Miranka Wirth, Dr. habil. Dipl.-Psych., German Center for Neurodegenerative Diseases (DZNE), Dresden; Principal Investigator: Olga M. Klimecki, PD Dr., German Center for Neurodegenerative Diseases (DZNE), Dresden

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): December 13, 2024
• Study Completion (Actual): December 13, 2024

Study Registration Dates

• First Submitted: July 27, 2024
• First Submitted That Met QC Criteria: July 27, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Adherence; Feasibility; Alzheimer's disease; Prevention; Aging; Well-being; Lifestyle; Dance; Quality-of-life; Dance-movement therapy
• Other Study ID Numbers: SR-EK-477112023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No