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TeNDER - affecTive basEd iNtegrateD carE for betteR Quality of Life - a feasibility trial in Germany (wave 1 and 2)

TeNDER - affecTive basEd iNtegrateD carE for betteR Quality of Life - a feasibility trial in Germany (wave 1 and 2) - TeNDER 1 and 2

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00024723
Enrollment
115
Registered
2021-03-09
Start date
2021-04-07
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Parkinson's disease Alzheimers disease and other types of dementia Cardiovascular diseases F00 F01 G30 F03 F02 I60 I61 I62 I63 I64 G20

Interventions

Group 1: Control group: Recieves standard therapy during hospitalisation. Additionally, after inclusion and before discharge, data will be gathered via the SF-36 questionnaire, a question from the tec

Sponsors

Schön Klinik Bad Aibling SE & Co. KG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: PATIENTS General • Age =60 years; • Have a caregiver or reference person. • Sufficient cognition capabilities to take informed decisions. • Acceptance to participate and have signed the informed consents. • Agree to use the provided devices; • Understand local language; • Ability to walk (with or without walking aids) or able to use wheelchair; • Compliance with scenario setting. AD • Patient with Alzheimer Disease accordingly to the NINCDS-ADRDA criteria or diagnosed dementia with MMSE score of 19 to 28; PD • Patients with confirmed diagnosis of Parkinson Disease accordingly to the criteria by United Kingdom Parkinson’s Disease Brain Bank (UKPDSBB) criteria or according to a neurological assessment; CVD • Patient that presents one of the following: o Cardiovascular failure grade II-III NYHA; o Coronary heart disease: both stable and acute coronary artery disease (ACS) with or without ST elevation; o Atrial Fibrillation; o Cardiac Pacemaker Carrier; o Cerebral Stroke; • Preserved language comprehension and communication skills. CAREGIVER General • To be able to consent and to comply with at least one of the following requisites: o To be employed by a public or private company or directly by the patients to provide direct care and thus support daily activities. o To live with and/or take care of a relative (or other close relationship) affected by Parkinson’s disease or Alzheimer’s disease or/and others dementia or CVD o To provide logistic support to a family member or a close friend affected by Parkinson’s disease or Alzheimer’s disease or/and others dementia or CVD. • Express readiness in the use of technologies to use the devices PROFESSIONALS General • To be able to consent and to be qualified and working in a medical or social area specialized in the care or support of Parkinson’s, Alzheimer’s or/and dementia and cardiovascular diseases (including general practitioners, nurses, social workers and others).

Exclusion criteria

Exclusion criteria: PATIENTS General Patients whose caregiver is unwilling to participate / assist; Patients / caregivers are unwilling to work with the technologies used in this project. AD • Advanced stages of the disease (for example Alzheimer’s disease: avoid GDS 6-7). • Patients with acute stroke in the previous six months (Hachinski scale score > 4); • Pyramidal and or Extrapyramidal signs at neurological examinations; • Patients’ whom informal carer (family care giver) is not willing to participate/assist; • Patients/carer is unwilling to work with technologies used in this project; • Advanced stage of disease. PD • Parkinsonism syndromes (Multiple System Atrophy (MSA) Progressive Supranuclear Palsy (PSP), Corticobasal Syndrome (CBS) • Dementia with Lewy bodies (DLB) • Patients with secondary parkinsonisms; • Patients’ whom informal carer (family care giver) is not willing to participate/assist; • Patients/carer is unwilling to work with technologies used in this project; • Advanced stage of disease. CVD • Patients’ whom informal carer (family care giver) is not willing to participate/assist; • Patients/carer is unwilling to work with technologies used in this project • ACS less than 4 weeks ago; • Severe aortic stenosis; • Severe visual or hearing impairment. CAREGIVER General • Caregivers not able to consent. • Caregivers not aware of the daily needs of PROFESSIONALS General • Not working as a professional involved in the care or support of AD, PD, CVD patients. • Working practice and environment not connected to Alzheimer’s’, Parkinson’s’ and other dementias. • Conflict of interest. • Not to be able to consent.

Design outcomes

Primary

MeasureTime frame
Data gathering via the SF-36 questionnaire (quality of life)

Secondary

MeasureTime frame
Usability of the TeNDER system (questionnaire of usability "User Experience Questionnaire")

Countries

Germany

Contacts

Public ContactBarbara Schaepers

Schön Klinik Bad Aibling SE & Co. KG

bschaepers@schoen-klinik.de08061-903-1952

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026