REMINDer - A Digital Environmental Enrichment Intervention
NCT Number: NCT06530277
Acronym: REMINDer
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: BEHAVIORAL: REMINDer (A digital environmental enrichment intervention)
Sponsor: German Center for Neurodegenerative Diseases (DZNE)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-01
Completion Date: 2024-12-01
Locations: German Center for Neurodegenerative Diseases (DZNE), Dresden, Dresden, Saxony, 01307, Germany

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.

Primary Outcome Measures: 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: 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)