HealthyREMINDerNCT06530277
REMINDer - A Digital Environmental Enrichment Intervention
A study testing REMINDer (A digital environmental enrichment intervention) in people with Healthy, run by German Center for Neurodegenerative Diseases (DZNE) at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- REMINDer (A digital environmental enrichment intervention)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2024to 13 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
German Center for Neurodegenerative Diseases (DZNE), Dresden
Dresden, Saxony, 01307
About this study
Official title: 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.
Read the 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
- Being tested
- REMINDer (A digital environmental enrichment intervention)
- Keywords
- Feasibility, Adherence, Prevention, Aging, Alzheimer's disease, Dance, Dance-movement therapy, Lifestyle, Well-being, Quality-of-life
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMINDer (A digital environmental enrichment intervention)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention, no intervention (AB) | Experimental | Beginning with the digital multimodal intervention (REMINDer) and then transitioning to a no intervention phase (sequence: AB). Receives: 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). Receives: Behavioral: REMINDer (A digital environmental enrichment intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: from baseline (t1) to the end of the 6-weeks intervention (t2)
Secondary outcomes (20)
Feasibility: reach
[participants enrolled / participants screened and eligible] * 100
Measured: End of 6-week-intervention (t2)
Feasibility: retention rate
[participants completing t3 / participants enrolled] * 100
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Aug 2024
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The intervention will be compared to a 6-week passive control (waitlist with delayed intervention, AB-BA design) in a cross-over study design.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miranka Wirth, German Center for Neurodegenerative Diseases (DZNE)
- Investigators
- Miranka Wirth, Dr. habil. Dipl.-Psych., Principal investigator, German Center for Neurodegenerative Diseases (DZNE), DresdenOlga M. Klimecki, PD Dr., Principal investigator, German Center for Neurodegenerative Diseases (DZNE), Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530277
- Sponsor's protocol ID
- SR-EK-477112023
- Acronym
- REMINDer
- Status last verified
- Jul 2024
- First submitted
- 27 Jul 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of a 12-weeks Digital Environmental Enrichment Intervention in Cognitively Unimpaired Older Adults (REMINDer)
- ClinicalTrials.gov ID
- NCT06530277
- Acronym / sponsor ID
- REMINDer / SR-EK-477112023
- Conditions
- Healthy
- Keywords
- Feasibility, Adherence, Prevention, Aging, Alzheimer's disease, Dance, Dance-movement therapy, Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)University, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention will be compared to a 6-week passive control (waitlist with delayed intervention, AB-BA design) in a cross-over study design.
| Arm | Type | Receives |
|---|---|---|
| Intervention, no intervention (AB) | Experimental | Behavioral: REMINDer (A digital environmental enrichment intervention)Beginning with the digital multimodal intervention (REMINDer) and then transitioning to a no intervention phase (sequence: AB). |
| No intervention, intervention (BA) | Experimental | Behavioral: REMINDer (A digital environmental enrichment intervention)Starting with a no intervention phase and subsequently moving to the digital multimodal intervention (REMINDer) (sequence: BA). |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention, no intervention (AB), No intervention, intervention (BA) |
Primary outcome
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).
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.
20 secondary outcomes
Feasibility: reach
Time frame: End of 6-week-intervention (t2)
Feasibility: retention rate
Time frame: 12 weeks post baseline (6 weeks post intervention) (t3)
Feasibility: dropout rate
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
Time frame: 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miranka Wirth, Dr. habil. Dipl.-Psych. principal investigator
German Center for Neurodegenerative Diseases (DZNE), Dresden
Olga M. Klimecki, PD Dr. principal investigator
German Center for Neurodegenerative Diseases (DZNE), Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REMINDer (A digital environmental enrichment intervention) in people with Healthy, run by German Center for Neurodegenerative Diseases (DZNE) at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Adherence to the intervention (time frame: from baseline (t1) to the end of the 6-weeks intervention (t2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.