REMINDer - A Digital Environmental Enrichment Intervention

NCT06530277 | Completed

• 1 other identifier: SR-EK-477112023
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Feasibility; Adherence; Prevention; Aging; Alzheimer's disease; Dance; Dance-movement therapy; Lifestyle; Well-being; Quality-of-life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (20)

• Feasibility: reach

  End of 6-week-intervention (t2)

• Feasibility: retention rate

  12 weeks post baseline (6 weeks post intervention) (t3)

• Feasibility: dropout rate

  a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (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: subjective cognition function

  a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)

Study Arms (2)

Intervention, no intervention (AB)

EXPERIMENTAL

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

Behavioral: REMINDer (A digital environmental enrichment intervention)

No intervention, intervention (BA)

EXPERIMENTAL

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

Behavioral: REMINDer (A digital environmental enrichment intervention)

Interventions

REMINDer (A digital environmental enrichment intervention) 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.

Intervention, no intervention (AB); No intervention, intervention (BA)

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• German Center for Neurodegenerative Diseases (DZNE): lead

Study Sites (1)

German Center for Neurodegenerative Diseases (DZNE), Dresden

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. habil. Dipl.-Psych.

Model Details: The intervention will be compared to a 6-week passive control (waitlist with delayed intervention, AB-BA design) in a cross-over study design.

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: July 31, 2024
• Study Start: August 1, 2024
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: February 6, 2025

Record last verified: 2024-07

Locations

DE (1)