Dementia-friendly Apothecaries as a Resource for Mental Heath in the Elderly
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-90
SponsorLudwig-Maximilians - University of Munich
About this trial
The DARE study (Dementia-Friendly Apothecaries as a Resource for Mental Health in the Elderly) is a multicenter, prospective cohort study aiming to identify individuals with cognitive impairments early in pharmacies and enhance their access to support services. Partner pharmacies are equipped with memory test stations, and pharmaceutical staff are trained to guide participants. The digital memory test evaluates cognitive, psychosocial, and health factors, displaying results in a traffic light graphic. Participants with concerning results are referred to specialists or support services.
The study's primary goals are to establish pharmacies as dementia screening hubs, improve care for affected individuals, promote interdisciplinary collaboration, and lay the groundwork for legal and billing frameworks. An optional subproject validates the screening through neurological evaluations.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age: Participants must be 60 years or older at the time of consent.
Language Proficiency: Sufficient knowledge of the German language to understand instructions and participate in the study.
Cognitive Status: Presence of self-reported, relative-reported, or pharmacist-identified cognitive impairments (e.g., memory problems or mild cognitive changes).
Consent: Ability to provide informed consent voluntarily.
Disqualifiers
Severe Sensory Impairments: Participants unable to see or hear well enough to complete the digital assessments or questionnaires.
Previous Dementia Diagnosis: Individuals with a prior formal diagnosis of dementia, whether with or without underlying pathology.
Severe Cognitive or Physical Impairments: Any condition that would prevent meaningful participation in the digital tests or structured screening process.
Trial population
Study Population: The study population consists of individuals aged 60 and older, recruited from urban and rural pharmacies. Participants include those with self-reported, relative-reported, or pharmacist-identified cognitive impairments ranging from initial symptoms to mild dementia. The cohort emphasizes diversity, capturing various demographic factors such as migration background, education level, marital status, and living situations, with a focus on underrepresented and underserved groups, including isolated individuals and those in rural areas.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,020 Participants
are grouped into 1 trial groupGroup A: prospective cohort study
Trial outcomes
Primary outcomes
1
Change in WHOQOL-BREF psychological domain score
Quality of life will be assessed using the World Health Organization Quality of Life Questionnaire, Brief Version (WHOQOL-BREF). The primary outcome is the change in the psychological domain score from baseline to 24-month follow-up. The psychological domain score will be calculated according to the WHOQOL-BREF scoring manual and transformed to a 0-100 scale, with higher scores indicating better quality of life. Unit of Measure points (0-100 scale) Time Frame Baseline and 24 months
Time frame
2025 - 2027Secondary outcomes
1
Healthcare utilization: number of healthcare contacts
Outcome Measure Title: Number of healthcare contacts Description: Healthcare utilization will be assessed using a structured study-specific questionnaire administered via telephone at 12- and 24-month follow-up. The outcome will be the number of healthcare contacts within the preceding 12 months, including visits to general practitioners, medical specialists, hospital admissions, and use of support services (e.g., counseling services, memory clinics, or social support programs). Unit of Measure: Number of contacts (count) Time Frame: 12 months and 24 months
Time frame
2025 - 20272
Proportion of participants with new diagnosis of cognitive or neurological disorder
Description: New diagnoses will be assessed via participant self-report during structured telephone interviews at follow-up. The outcome is defined as the proportion of participants reporting a newly established diagnosis of a cognitive or neurological disorder (e.g., mild cognitive impairment or dementia) since baseline. Where feasible, diagnoses will be verified through available clinical documentation. Unit of Measure: Percentage of participants (%) Time Frame: 12 months and 24 months
Time frame
2025 - 2027Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ludwig-Maximilians - University of Munich
Lead sponsor
Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention
Collaborator
Source ClinicalTrials.gov