REMINDer - A Digital Environmental Enrichment Intervention

NCT ID: NCT06530277

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2024-12-13

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention, no intervention (AB)

Beginning with the digital multimodal intervention (REMINDer) and then transitioning to a no intervention phase (sequence: AB).

Group Type: EXPERIMENTAL

REMINDer (A digital environmental enrichment intervention)

Intervention Type: BEHAVIORAL

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.

No intervention, intervention (BA)

Starting with a no intervention phase and subsequently moving to the digital multimodal intervention (REMINDer) (sequence: BA).

Group Type: EXPERIMENTAL

REMINDer (A digital environmental enrichment intervention)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

German Center for Neurodegenerative Diseases (DZNE)

OTHER

Sponsor Role: lead

Responsible Party

Miranka Wirth

Dr. habil. Dipl.-Psych.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miranka Wirth, Dr. habil. Dipl.-Psych.

Role: PRINCIPAL_INVESTIGATOR

German Center for Neurodegenerative Diseases (DZNE), Dresden

Olga M. Klimecki, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

German Center for Neurodegenerative Diseases (DZNE), Dresden

Locations

German Center for Neurodegenerative Diseases (DZNE), Dresden

Dresden, Saxony, Germany

Countries

Germany

Other Identifiers

SR-EK-477112023

Identifier Type: -

Identifier Source: org_study_id