Adaptation and validation of the Erlangen activities of daily living test to the Latin American cultural area
| ISRCTN | ISRCTN87242816 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87242816 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsors | Universitätsklinikum Erlangen, Centro Mexicano Alzheimer, Universidad Nacional Autónoma de México |
| Funders | Universitätsklinikum Erlangen, Centro Mexicano Alzheimer, Universidad Nacional Autónoma de México |
- Submission date
- 09/10/2025
- Registration date
- 02/12/2025
- Last edited
- 02/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Dementia is one of the most common causes of health impairments in older people. Impairments in activities of daily living (ADL) are particularly critical, as they sustainably restrict the independence of those affected. Therefore, the reliable and valid assessment of ADL is of outstanding importance for the diagnosis of dementia, but also in the investigation of the effectiveness of new treatment methods for dementia. Often, limitations in ADL are assessed with proxy-rated instruments, completed by relatives of the affected person or caregivers, sometimes also by self-assessment in cases of mild cognitive impairment (MCI) or mild dementia. However, both self-assessments and proxy-rated assessments are biased in their assessment of what ADLs a person is still capable of performing. This is partly because a certain living environment (e.g. independent living or day-care settings) no longer allows participants to perform ADLs spontaneously.
It is therefore very important to be able to measure ADL capabilities with a performance test. Researchers have therefore developed and published the Erlangen Test of Activities of Daily Living (E-ADL), which has proven its validity and reliability, particularly in people with moderate to severe dementia. In the present study, the validity and reliability of a Spanish version adapted to the Mexican context (E-ADL-LAT) are to be evaluated. On the one hand, the performance test items of the E-ADL were culturally adapted to the Mexican culture. On the other hand, two very easy tasks were replaced by culturally adapted tasks from the ETAM to create a test instrument that can be used for people with severe dementia as well as for people with mild to moderate dementia. Thus, it should be possible to assess their degree of independence in everyday life (i.e. their level of impairment in ADL) validly and reliably.
Who can participate?
People with mild, moderate, and severe dementia or mild cognitive impairment, living independently or attending day-care services, who speak fluent Spanish and do not have severe motor impairments or current psychosis, are eligible to participate. Participants must have a close caregiver who can also provide informed consent.
What does the study involve?
The study will investigate the validity and reliability of the culturally adapted Spanish version of the Erlangen Test of Activities of Daily Living (E-ADL-LAT) in people with mild cognitive impairment as well as in people with mild to severe dementia in Mexico. Participants will complete the performance test (E-ADL-LAT) either in person or remotely, and caregivers will provide information for the Barthel Index and selected NOSGER subscales. Cognitive abilities will be assessed using the MoCA.
What are the possible benefits and risks of participating?
All participants may benefit from the structured assessment of their remaining ADL capabilities, which may not be recognized in daily life. Identifying these abilities can support more needs-oriented care and appropriate assistance in daily activities. Based on previous validation studies of the E-ADL and ETAM, no risks are expected during participation.
Where is the study run from?
1. Centro Mexicano Alzheimer, CDMX, Mexiko
2. University Clinic Erlangen, Erlangen, Germany
When is the study starting and how long is it expected to run for?
October 2025 to December 2026
Who is funding the study?
There is no external funding. The study is realized with infrastructure and human resources from the Centro Mexicano Alzheimer, the University Clinic Erlangen, and the Universidad Nacional Autónoma de México
Who is the main contact?
1. Prof. Dr. Carolin Donath, carolin.donath@uk-erlangen.de
2. Maestra Regina Altena, regina@cmalzheimer.org.mx
3. Maestra María Teresa Gutiérrez Alanís, teregut2003@yahoo.com.mx
Contact information
Scientific, Principal investigator
University Clinic Erlangen
Psychiatric and Psychotherapeutic Clinic
Schwabchanlage 6
Erlangen
91054
Germany
| Phone | 091318534526 |
|---|---|
| carolin.donath@uk-erlangen.de |
Public
Centro Mexicano, Alzheimer, Av. Insurgentes Sur 2047 B, San Angel, Alvaro Obgregon
CD DE MEXICO
0100
Mexico
| Phone | +525519488192 |
|---|---|
| regina@cmalzheimer.org.mx |
Public
Universidad Nacional Autónoma de México, Circuito Ciudad Universitaria
CD DE MEXICO
04510
Mexico
| Phone | +525529409478 |
|---|---|
| teregut2003@yahoo.com.mx |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational validation study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Objectively and culturally specific assessment of everyday practical skills in people with dementia - adaptation and validation of the Erlangen ADL test (E-ADL) to the Latin American cultural area (E-ADL_LAT) |
| Study objectives | Primary Objectives: 1. Cultural adaptation of the Erlangen ADL Test (E-ADL) for the Latin American context (E-ADL_LAT): To develop a culturally appropriate version of the E-ADL for use with people with dementia in Mexico and Spanish-speaking Latin America, enabling objective assessment of daily living skills through a performance-based test. Expected outcome: Obtain a valid, reliable, and culturally adapted Latin American version of the E-ADL test. Secondary Objectives (Validation Hypotheses): 1. Assessment of test administration objectivity: The E-ADL_LAT will demonstrate high administration objectivity due to a precise test manual. 2. Assessment of scoring objectivity: The E-ADL_LAT will demonstrate high scoring objectivity due to a detailed scoring guide including anchor examples. 3. Test-retest reliability: The E-ADL_LAT will show satisfactory test-retest reliability. 4. Interrater reliability: The E-ADL_LAT will show satisfactory interrater reliability. 5. Internal consistency: The E-ADL_LAT will demonstrate satisfactory internal consistency, measured via Cronbach’s Alpha. 6. Convergent validity: The E-ADL_LAT will show substantial correlations with related constructs, including cognitive performance and instrumental activities of daily living (IADL). 7. Concurrent validity: The E-ADL_LAT will show substantial correlations with an established external measure of daily living skills (Barthel Index), indicating it measures the same construct. 8. Discriminant validity: The E-ADL_LAT will demonstrate low correlations with unrelated constructs (agitation/aggression, depression, social behavior), supporting its discriminant validity. |
| Ethics approval(s) |
Not yet submitted |
| Health condition(s) or problem(s) studied | Dementia and Mild Cognitive Impairment |
| Intervention | The E-ADL-LAT is a standardized performance test consisting of six tasks: Task 1: Making a Bean Taco (i.e. spreading one spoonful of beans onto a tortilla and rolling the tortilla as if preparing it to be eaten as a taco) Task 2: Pouring a Beverage (i.e. opening the bottle and filling the glass up to the marked line) Task 3: Putting on a T-shirt (i.e. taking the t-shirt, turning it to the correct side, and putting it on as if getting dressed to go out) Task 4: Hand Washing (i.e. washing hands with soap and then drying them afterwards) Task 5: Making a Phone Call (i.e. looking up Dr. Orozco’s number in a phone list, dialing the number, and listening to the voicemail to find out the office hours on Tuesdays) Task 6: Handling Finances (i.e. choosing the cheapest price for eggs from three flyers, calculating the total amount required for all the products, and taking the necessary amount from a wallet) Each task is rated by the tester according to a standardized scale from 0 to 6 points. The total score of the E-ADL-LAT ranges from 0 to 36 points, with a higher score indicating a better capability in performing ADL. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Activities of Daily Living measured with the culturally adapted Latin American version of the Erlangen Test of Activities in Daily Living (E-ADL-LAT) at baseline. |
| Key secondary outcome measure(s) |
Measured at baseline: |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 55 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Community-dwelling people living with cognitive impairments 2. Symptoms of dementia (any type except Parkinson’s disease dementia) or mild cognitive impairment (MoCA score < 26) 3. Sufficient vision and hearing (use of supporting devices included) 4. No paralysis of upper extremities 5. Fluent oral Spanish sufficient to understand and follow test instructions 6. Availability of a close caregiving relative who provides consent, agrees to participate in the study-related survey and answers the peer-rating scales, supports the participant’s involvement. 7. Provision of informed consent by the participant; if lacking capacity, consent must be obtained from the legally authorized representative |
| Key exclusion criteria | 1. Parkinson’s disease dementia 2. Severe motor impairments of the upper extremities (paralysis or comparable) 3. Insufficient vision or hearing that cannot be adequately corrected with aids (e.g. glasses, hearing devices) 4. Psychotic disorder 5. Severe depressive episode |
| Date of first enrolment | 01/11/2025 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Germany
- Mexico
Study participating centres
Ciudad de México, CDMX
01060
Mexico
Erlangen
91056
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/10/2025: Trial's existence confirmed by Bavarian Academic Center for Latin America (BAYLAT).
