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A controlled pilot study investigating the feasibility, acceptability, and effects of the personalized communication medium “HILDE” on loneliness and affective well-being in older adults.

A controlled pilot study investigating the feasibility, acceptability, and effects of the personalized communication medium “HILDE” on loneliness and affective well-being in older adults. - HILDE-Eval

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00039046
Enrollment
30
Registered
2026-01-21
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Loneliness and affective well-being in older adults (65 years and older)

Interventions

Group 1: Intervention group: use of the personalized communication system and demonstrator “HILDE” (a haptic device / tangible user interface) to listen to personalized, biography-based audio messages
recommendation: two sessions per week between 20 and 45 minutes. Relatives are asked to actively contribute to the design (e.g., incorporating biographical memories through photos, objects).

Sponsors

Charité - Universitätsmedizin Berlin (Forschungsgruppe Geriatrie)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: Minimum age 65 years. Participants understand German-language instructions and are able to provide informed consent. Sufficient hearing ability to understand spoken language. If cognitive impairments are present: mild to moderate severity (provided the person is capable of giving informed consent). Additionally for the control group: access to a smartphone for personal use (can be provided by study staff if needed).

Exclusion criteria

Exclusion criteria: No relatives/next of kin available (assessment of social status). Severe dementia (based on diagnosis or medical assessment) or inability to provide informed consent. Acute, severe illness. Complete deafness.

Design outcomes

Primary

MeasureTime frame
Primary endpoint: Adjusted post-score on the UCLA Loneliness Scale (3-item version) at follow-up (T1) after 4 weeks, adjusted for the baseline (T0) value.

Secondary

MeasureTime frame
Secondary endpoints: Mental well-being (PHQ-2; GAD-2), positive/negative affect (i-PANAS-sf), general (life) satisfaction (Subjective Happiness Scale, SHS), usability (UEQ-S), acceptance (adapted UTAUT2-based questionnaire including social support/influence and self-efficacy), objective usage data (number of token placements/interactions and total usage time in minutes).

Countries

Germany

Contacts

Public ContactNils Lahmann

Charité - Universitätsmedizin Berlin (Forschungsgruppe Geriatrie)

nils.lahmann@charite.de+49 30 450 529 066

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026