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ResQCare-MCI: A prospective, exploratory study evaluating the questionnaire on caregiver resilience and burden in relatives of people living with prodromal syndrome

ResQCare-MCI: A prospective, exploratory study evaluating the questionnaire on caregiver resilience and burden in relatives of people living with prodromal syndrome - ResQCare-MCI

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00034543
Enrollment
160
Registered
2024-08-27
Start date
2025-03-19
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

Burden of people living with prodromal dementia syndrome and their primary caregivers

Interventions

Group 1: People with prodromal syndrome and their primary caregivers are included at their first appointment in the outpatient memory clinic. After the routine assessment (Geriatric Depression Scale (
- Person with prodromal syndrome: perceived stress, theory of mind, insight into illness

Sponsors

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Psychiatrie und Psychotherapie, ZpGA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Person living with prodromal syndrome: - Prodromal syndrome in the assessment of everyday activity according to a Clinical Dementia Rating (CDR = 0.5) - adequate German language skills - GDS-15 < 5 and clinically no relevant depressive syndrome - Relatives present - No current inpatient stay and not living in a nursing home Informal caregiver: - highest degree of availability to the person with prodromal syndrome compared to other caregivers - Living in the same household as the person with prodromal syndrome - adequate German language skills

Exclusion criteria

Exclusion criteria: Person living with prodromal syndrom: - No below-average cognitive performance in one or more cognitive domains (SD = 1 from the mean of the age- and education-adjusted norm) - [for hair sampling: Use of cortisone preparations (cortisol, hydrocortisone and cortisone)] Informal caregiver: - Known current diagnosis of depression / current psychiatric and/or psychotherapeutic treatment / severe depression symptoms in QIDS-SR16 survey = 16 points - Psychotic syndrome in the context of internal or psychiatric illnesses - [for hair sampling: Use of cortisone preparations (cortisol, hydrocortisone and cortisone)]

Design outcomes

Primary

MeasureTime frame
Validity and predictive value of the ResQCare-MCI at two measurement times 6 months apart (T0 and T1)

Secondary

MeasureTime frame
Measurable burden on relatives (depression (Quick Inventory of Depressive Symptomatology, QIDS-SR16), resilience (Resilience Scale, RS-11), stress experience (Perceived Stress Scale, PSS-10), health status according to the International Classification of Functioning (ICF), WHODAS 2.0)) at T0 and T1; Association and prediction of ResQCare-MCI with and of at T0) sociodemographic data, cognitive performance profile (Mini-Mental Status Test, MMST, neuropsychological examination), as well as affective and cognitive facets of the Theory of Mind (Story-Based Empathy Task, SET); at T0 and T1) psychological and behavioral symptoms (Neuropsychiatric Inventory, NPI), competence in everyday life (Scale for the Assessment of Impairment of Daily Living Skills in Older Patients with Cognitive Impairment, Bayer-ADL), and awareness of symptoms in people living with prodromal syndrome (Abridged Anosognosia Questionnaire-Dementia, aAQ-D)

Countries

Germany

Contacts

Public ContactSvenja Palm

Universitätsmedizin der JGU Mainz, Klinik für Psychiatrie und Psychotherapie, ZpGA

Svenja.Palm@unimedizin-mainz.de+49 6131 17 37

Outcome results

None listed

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