DementiaSAIN_UMRNCT05885620
SAMi Intervention Study to Evaluate Smartwatch Interventions in Persons With MCI and Dementia
A study testing drinking reminder and cognitive task (smartwatch-based application) in people with Dementia and Mild Cognitive Impairment, run by University of Rostock at 1 site in Germany.
Trial summary
Assistive Technologies (ATs) can help people living with dementia (PwD) maintain their everyday activity. Still, there is a gap between potential and supply. Involving future users can close the gap. But the value of participation from PwD is unclear. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dementia, Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- drinking reminder and cognitive task (smartwatch-based application)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 10 Nov 2020to 10 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of mild cognitive impairment or dementia
- Mini Mental Status Examination (MMSE) ≥ 9 and ≤ 28 points
Who cannot join
- clinically relevant impairment of visual acuity and/or hearing
- relevant speech/language impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensor-based Individualized Activity Management System for People With Dementia: Intervention Study
Assistive Technologies (ATs) can help people living with dementia (PwD) maintain their everyday activity. Still, there is a gap between potential and supply. Involving future users can close the gap. But the value of participation from PwD is unclear.
The study examined smartwatch interactions from people with dementia or with mild cognitive impairment. Participants received "regularly" (n=20) or "intensively" (n=20) intrusive audio-visual prompts on a customized smartwatch to perform everyday tasks. Participants' reactions were observed via cameras. Users' feedback was captured with questionnaires.
Read the detailed description
This was a mixed methods study involving different stakeholder groups in a stepwise approach towards the user-centered evaluation of a smartwatch-based application for PwD. A preparatory qualitative study focused on identifying needs and requirements for mobile assistive devices. An observatory field study revealed potential use cases for smartwatches for persons with dementia. The subsequent intervention study examined smartwatch interactions and gathered users' feedback concerning usability, design, usefulness and concerns. Participants with mild cognitive impairment or dementia received either "regularly" (n=20) or "intensively" (n=20) intrusive audio-visual prompts to perform everyday tasks. All participants were prompted to complete two tasks, prompts were repeated up to three times if they failed to completely solve a task. Prompts were triggered using a smartphone as remote control. Patient reactions were observed via video cameras. Each task was rated with 1 point for success, 0.5 for incomplete task fulfillment or 0 for failure. Both tasks were summarized, resulting in success values from 0 to 2 points.
Abbreviations:
PwD: people with dementia MCI: mild cognitive impairment AT: assistive technology
- Conditions
- Dementia, Mild Cognitive Impairment, Alzheimer Disease, Dementia With Lewy Bodies, Dementia, Vascular, Dementia, Mixed
- Being tested
- drinking reminder and cognitive task (smartwatch-based application)
- Keywords
- Assistive technology, User-centered design, Usability, Smartwatch, Dementia
- Medical subject headings
- Dementia, Cognitive Dysfunction, Alzheimer Disease, Lewy Body Disease, Dementia, Vascular, Mixed Dementias, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drinking reminder and cognitive task (smartwatch-based application)Device
task A: prompt to drink some water task B: prompt to circle bells on a sheet
| Study group | Role | What they receive |
|---|---|---|
| regular | Active comparator | components of interventions:
1. short vibration and short audio signal,
2. textual greeting,
3. textual prompt,
4. picture
5. short vibration Receives: Device: drinking reminder and cognitive task (smartwatch-based application) |
| intense | Active comparator | components of interventions:
1. long vibration and long audio signal,
2. textual greeting,
3. textual prompt and speech output,
4. animation
5. long vibration Receives: Device: drinking reminder and cognitive task (smartwatch-based application) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success
Observation of success regarding to researchers' success protocol.
Measurement is performed in the following:
- Live observation during procedure rated with 0, 0.5 or 1 point: 0 points: Participant shows no activity that could potentially lead to task fulfillment.
0.5 points: Participant intiated actions that result in incomplete task fulfillment.
1 point: Participant completely fullfilled the task (task A: drunk some water tasb B: circled something on the worksheet with the pencil).
Only the best performance for each task was rated. Repetitions were not scored. The scores of both tasks were summarized, resulting in success values from 0 to 2 points.
Measured: during procedure
Secondary outcomes (4)
Usability
Measurement of perceived usability according to score calculated from 10 items of post-intervention questionnaire.
Items were answered on a 5-step Likert scale. Negatively worded items were converted.
Each item was rated with 0,1,2,3 or 4 corresponding to the answer on the Likert scale with the following direction: 0 is used for the strongest disagreement, 4 for strongest agreement. Then the sum of all scores is multiplied with 2.5, leading to possible usability scores from 0 to 100. Higher scores present better usability.
Measured: directly after intervention
Design
Measurement of satisfaction with design assessed with 6 items of post-intervention questionnaire.
Items were answered on a 5-step Likert scale. Each item was rated with 1,2,3, 4 or 5 corresponding to the answer on the Likert scale with the following direction: 1 is used for the strongest agreement, 5 for the strongest disagreement.
Lower scores present higher satisfaction with design.
Measured: directly after intervention
Usefulness
Assessment of perceived usefulness captured with 3 items of post-intervention questionnaire.
Items were answered on a 5-step Likert scale. Each item was rated with 1,2,3, 4 or 5 corresponding to the answer on the Likert scale with the following direction: 1 is used for the strongest agreement, 5 for the strongest disagreement.
Lower scores present higher perceived usefulness.
Measured: directly after intervention
Concerns
Assessment of concerns and barriers captured with 7 items of post-intervention questionnaire.
Items were answered on a 5-step Likert scale. Each item was rated with 1,2,3, 4 or 5 corresponding to the answer on the Likert scale with the following direction: 1 is used for the strongest agreement, 5 for the strongest disagreement. Negatively worded items (5 items) were converted.
Lower scores represent less concerns.
Measured: directly after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start10 Nov 2020
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Neurodegenerative Diseases (DZNE), Fraunhofer Institute
- Responsible party
- Principal investigator, Doreen Goerss, University of Rostock
- Investigators
- Doreen Görß, MD, Principal investigator, Rostock University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885620
- Sponsor's protocol ID
- A 2020-0071
- Acronym
- SAIN_UMR
- Status last verified
- Jun 2023
- First submitted
- 9 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goerss D, Kohler S, Rong E, Temp AG, Kilimann I, Bieber G, Teipel S. Smartwatch-Based Interventions for People With Dementia: User-Centered Design Approach. JMIR Aging. 2024 Jun 7;7:e50107. doi: 10.2196/50107.
PubMed 38848116
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor-based Individualized Activity Management System for People With Dementia: Intervention Study
- ClinicalTrials.gov ID
- NCT05885620
- Acronym / sponsor ID
- SAIN_UMR / A 2020-0071
- Conditions
- Dementia, Mild Cognitive Impairment, Alzheimer Disease, Dementia With Lewy Bodies, Dementia, Vascular, Dementia, Mixed
- Keywords
- Assistive technology, User-centered design, Usability, Smartwatch, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Collaborators
- German Center for Neurodegenerative Diseases (DZNE), Fraunhofer Institute
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assistive Technologies (ATs) can help people living with dementia (PwD) maintain their everyday activity. Still, there is a gap between potential and supply. Involving future users can close the gap. But the value of participation from PwD is unclear.
The study examined smartwatch interactions from people with dementia or with mild cognitive impairment. Participants received "regularly" (n=20) or "intensively" (n=20) intrusive audio-visual prompts on a customized smartwatch to perform everyday tasks. Participants' reactions were observed via cameras. Users' feedback was captured with questionnaires.
Detailed description
This was a mixed methods study involving different stakeholder groups in a stepwise approach towards the user-centered evaluation of a smartwatch-based application for PwD. A preparatory qualitative study focused on identifying needs and requirements for mobile assistive devices. An observatory field study revealed potential use cases for smartwatches for persons with dementia. The subsequent intervention study examined smartwatch interactions and gathered users' feedback concerning usability, design, usefulness and concerns. Participants with mild cognitive impairment or dementia received either "regularly" (n=20) or "intensively" (n=20) intrusive audio-visual prompts to perform everyday tasks. All participants were prompted to complete two tasks, prompts were repeated up to three times if they failed to completely solve a task. Prompts were triggered using a smartphone as remote control. Patient reactions were observed via video cameras. Each task was rated with 1 point for success, 0.5 for incomplete task fulfillment or 0 for failure. Both tasks were summarized, resulting in success values from 0 to 2 points.
Abbreviations:
PwD: people with dementia MCI: mild cognitive impairment AT: assistive technology
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| regular | Active comparator | Device: drinking reminder and cognitive task (smartwatch-based application)components of interventions: 1. short vibration and short audio signal, 2. textual greeting, 3. textual prompt, 4. picture 5. short vibration |
| intense | Active comparator | Device: drinking reminder and cognitive task (smartwatch-based application)components of interventions: 1. long vibration and long audio signal, 2. textual greeting, 3. textual prompt and speech output, 4. animation 5. long vibration |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of mild cognitive impairment or dementia
- Mini Mental Status Examination (MMSE) ≥ 9 and ≤ 28 points
Key exclusion criteria (2 listed)
- clinically relevant impairment of visual acuity and/or hearing
- relevant speech/language impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drinking reminder and cognitive task (smartwatch-based application)task A: prompt to drink some water task B: prompt to circle bells on a sheet | Device | intense, regular |
Primary outcome
Success
Time frame: during procedure
Observation of success regarding to researchers' success protocol. Measurement is performed in the following: 1) Live observation during procedure rated with 0, 0.5 or 1 point: 0 points: Participant shows no activity that could potentially lead to task fulfillment. 0.5 points: Participant intiated actions that result in incomplete task fulfillment. 1 point: Participant completely fullfilled the task (task A: drunk some water tasb B: circled something on the worksheet with the pencil). Only the best performance for each task was rated. Repetitions were not scored. The scores of both tasks were summarized, resulting in success values from 0 to 2 points.
4 secondary outcomes
Usability
Time frame: directly after intervention
Design
Time frame: directly after intervention
Usefulness
Time frame: directly after intervention
Concerns
Time frame: directly after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Derived from this study: PubMed 38848116Goerss D, Kohler S, Rong E, Temp AG, Kilimann I, Bieber G, Teipel S. Smartwatch-Based Interventions for People With Dementia: User-Centered Design Approach. JMIR Aging. 2024 Jun 7;7:e50107. doi: 10.2196/50107.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doreen Görß, MD principal investigator
Rostock University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drinking reminder and cognitive task (smartwatch-based application) in people with Dementia and Mild Cognitive Impairment, run by University of Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success (time frame: during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05885620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.