Digital and paper-based DemTect for the detection of cognitive changes: How well do they agree and how good is the usability of the digital format?
| ISRCTN | ISRCTN15891080 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15891080 |
- Submission date
- 08/06/2023
- Registration date
- 09/06/2023
- Last edited
- 13/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Cognitive impairment and its associated limitations have a major impact on the health of people worldwide and result in high healthcare costs. Patients recovering from serious illness, major surgery or infection often report temporary or long-lasting cognitive impairment. This also affects individuals recovering from a coronavirus infection. Approximately 20% of individuals with a confirmed coronavirus infection report long-lasting symptoms (or Long Covid) including cognitive difficulties such as forgetfulness, lack of focus, and impaired thinking. Cognitive assessments are critical in the management of individuals with Long Covid and play an important role in identifying cognitive impairment.
One of the most commonly used instruments to screen for cognitive impairment is DemTect. DemTect is usually administered by paper-and-pencil in a clinic by a physician or other health care professional. The company movos AG (https://www.movos.ch/) is currently developing a digital version (mobile app) of DemTect. The mobile app will allow individuals to perform DemTect by themselves without a health care professional. This may provide a more efficient and user-friendly screening method. The DemTect validation study will investigate how comparable and feasible the digital version of DemTect is compared to the paper-based version.
Who can participate?
A random selection of individuals from the general population of the Canton of Zurich, who participated in the Corona Immunitas Zurich seroprevalence studies (https://www.corona-immunitas.ch) and consented to be contacted for further research purposes, will be invited to participate in this study.
What does the study involve?
All participants will be invited for two study visits at the study center during which they will complete the digital and paper-based versions of DemTect. The order of the versions is random. At the first study visit, participants will be randomly divided into two groups:
• Group 1 fills out the paper-based version of DemTect at study visit 1 and the digital version at study visit 2 (three weeks after study visit 1).
• Group 2 will complete the digital version of DemTect at study visit 1 and the paper-based version at study visit 2 (three weeks after study visit 1).
Three weeks after the second visit, participants will be asked to complete the digital version of the DemTect on their own at home. They will also receive a questionnaire asking about the quality and their preferences regarding the two different versions.
What are the possible benefits and risks of participating?
The results of this study will help to develop a potentially more efficient and user-friendly screening method for detecting cognitive impairment. The risks of participating in this study are minimal.
Where is the study run from?
The study is run from the Epidemiology, Biostatistics and Prevention Institute (EBPI) at the University of Zurich, Switzerland.
When is the study starting and how long is it expected to run for?
May 2023 to January 2024
Who is funding the study?
Movos AG (Switzerland)
Who is the main contact?
Dr. Tala Ballouz, MD PhD MPH
tala.ballouz@uzh.ch
Contact information
Scientific
Epidemiology, Biostatistics and Prevention Institute (EBPI)
University of Zurich
Hirschengraben 84
Zurich
8001
Switzerland
 ORCID ID |
0000-0003-4721-1879 |
|---|---|
| Phone | +41 44 634 46 10 |
| miloalan.puhan@uzh.ch |
Scientific
Epidemiology, Biostatistics and Prevention Institute (EBPI)
University of Zurich
Hirschengraben 84
Zurich
8001
Switzerland
| ORCID ID |
0000-0002-7134-1000 |
|---|---|
| Phone | +41 44 634 43 60 |
| anja.frei@uzh.ch |
Public
Epidemiology, Biostatistics and Prevention Institute (EBPI)
University of Zurich
Hirschengraben 84
Zurich
8001
Switzerland
| ORCID ID |
0000-0003-2334-8600 |
|---|---|
| Phone | +41 44 634 35 48 |
| tala.ballouz@uzh.ch |
Study information
| Study design | Single-centre randomized crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Validation of self-administered digital DemTect for neurocognitive screening: a randomized crossover trial |
| Study objectives | The overall aim of this validation trial is to evaluate the agreement and usability of the digital (mobile-based) self-administered format of DemTect (SA-DemTect) for the detection of cognitive impairment compared with the traditional paper interviewer-administered format ( IA-DemTect). We hypothesize that there is no difference between the scores of the two DemTect formats with regards to the total or domain scores, providing evidence of mutual exchangeability of the two formats. |
| Ethics approval(s) |
Approved 03/08/2023, Cantonal Ethics Committee Zurich (Stampfenbachstrasse 121, Zurich, CH-8090, Switzerland; +41 43 259 79 70; Info.KEK@kek.zh.ch), ref: 2023-01039 |
| Ethics approval additional information | Approval pending, Ethics committee of the canton of Zurich, Switzerland (Kantonale Ethik-Kommission Zürich: Stampfenbachstrasse 121, CH-8090 Zurich, Switzerland; +41 43 259 79 70; Info.KEK@kek.zh.ch). |
| Health condition(s) or problem(s) studied | Detection of cognitive changes (mild cognitive impairment and dementia) using DemTect - a validated neurocognitive screening instrument. |
| Intervention | Since this study is a crossover trial, all participants will receive both IA-DemTect and SA-DemTect and will act as their own controls. Eligible participants will be randomly assigned in a 1:1 allocation ratio using age stratified (<65 years and ≥65 years) block randomization to receive the two formats in a randomized order. The list of random numbers will be created in R software using the package blockrand. According to the allocation sequence, participants will receive either : - SA-DemTect first followed by IA-DemTect, or - IA-DemTect followed by SA-DemTect. These two assessments will be conducted during two study visits at the study center. SA-DemTect will be self-administered by participants on their mobile phones, and IA-DemTect will be conducted by trained research personnel. All participants will afterwards be asked to conduct the SA-DemTect assessment again at home. At the end of this third assessment, participants will receive an electronic questionnaire that assesses the usability of the app and their preference with regards to the standard or digital version. Learning/practice effects are reduced by a three-week latency period between each of the assessments and by using three different versions of DemTect (A-C). For the administration of the IA format, we will use DemTect version B and for the administration of the SA format, we will use DemTect version A or C. 1. Paper-based interviewer-administered DemTect The DemTect assessment contains five short and easy-to-administer tasks that assess the short and long-term verbal memory, working memory executive function, mental flexibility and language. The IA-DemTect is normally administered by healthcare professionals and requires little training. The total administration time is 8 to 10 minutes. For the purpose of this study, the assessment will be shown on a trial-specific web-based platform (developed by movos AG; accessed on a computer) rather than on paper. The administration of the IA-DemTect via the platform is identical to the traditional paper version and allows ease of data collection and minimizes error (e.g., score calculation errors). 2. Digital-based self-administered DemTect The SA-DemTect will be available via an app that is compatible with both iOS and Android operated devices. Participants will be able to download and install the app with a personalized link and ID. Participants will only be able to access the app during the specific study visit in which they receive the SA-DemTect (app will be automatically deactivated after a single assessment completion). At the time of the third assessment (i.e., three weeks after the second visit), the app will be reactivated for another single use. The content and structure are identical to the standard IA-DemTect format with test instructions being shown directly on the phone. For tasks that usually require trained personnel to list words or numbers, the participant will be able to hear the instructions (numbers/words) directly through the app and will be asked to type or record them, depending on the individual task. |
| Intervention type | Other |
| Primary outcome measure | Degree to which the SA- and IA-DemTect scores and sub-scores agree with each other (assessed by the intraclass correlation coefficient). SA- and IA-DemTect scores are assessed at baseline and week three. |
| Secondary outcome measures | 1. Agreement (assessed by kappa coefficients) of SA- and IA-DemTect in the classification of cognitive impairment (none, mild and significant cognitive impairment). SA- and IA-DemTect scores are assessed at baseline and week three. 2. Agreement of the two SA-DemTect assessments scores with each other (i.e., at-home versus clinical setting), as measured at baseline or week three (depending on the allocation sequence) and week six. 3. Differences in completion times of SA- and IA-DemTect assessments, measured at baseline and week three. 4. Usability of SA-DemTect evaluated at week six using participant questionnaires, and 5. Participant preferences with regards to the SA- and IA-DemTect evaluated at week six using participant questionnaires. |
| Overall study start date | 01/05/2023 |
| Completion date | 20/01/2024 |
Eligibility
| Participant type(s) | Population |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 134 |
| Total final enrolment | 153 |
| Key inclusion criteria | 1. Aged 18 years or older 2. Fluent in German (reading and writing) 3. No documented neuropsychiatric disturbances influencing cognitive ability and ability to follow the study procedures 4. Have a mobile phone 5. Provided informed consent |
| Key exclusion criteria | All individuals not fulfilling the previously mentioned inclusion criteria will be excluded. |
| Date of first enrolment | 09/08/2023 |
| Date of final enrolment | 08/11/2023 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Hirschengraben 84
Zurich
8001
Switzerland
Sponsor information
University/education
Epidemiology, Biostatistics and Prevention Institute (EBPI)
Hirschengraben 84
Zurich
8001
Switzerland
| Phone | +41 44 634 46 10 |
|---|---|
| miloalan.puhan@uzh.ch | |
| Website | https://www.ebpi.uzh.ch/en.html |
"ROR" |
https://ror.org/02crff812 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 15/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in peer-reviewed scientific journals. |
| IPD sharing plan | Individual participant level data underlying the results reported in the publications will be made available at a later date directly from the authors or via an openly accessible repository. tala.ballouz@uzh.ch |
Editorial Notes
13/05/2024: The following changes have been made:
1. The overall study end date was changed from 29/12/2023 to 20/01/2024.
2. The intention to publish date was changed from 01/08/2024 to 15/12/2024.
15/11/2023: The intention to publish date has been changed from 01/06/2023 to 01/08/2024.
14/11/2023: The following changes have been made:
1. The recruitment end date has been changed from 24/10/2023 to 08/11/2023.
2. The overall study end date has been changed from 23/10/2023 to 29/12/2023 and the plain English summary updated accordingly.
3. The final enrolment number has been added.
09/08/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 03/08/2023 to 09/08/2023.
2. The recruitment end date was changed from 18/10/2023 to 24/10/2023.
05/07/2023: The following updates have been made:
1. The overall study end date has been changed from 23/10/2023 to 23/11/2023 and the plain English summary updated accordingly.
2. The recruitment start date has been changed from 01/07/2023 to 03/08/2023.
3. The recruitment end date has been changed from 18/09/2023 to 18/10/2023.
09/06/2023: Trial's existence confirmed by Canton of Zurich Cantonal Ethics Committee
