Our main objective is to investigate the feasibility of measuring NPS in daily life with experience sampling and wearable technology. Our secondary objective is to investigate the presence of and fluctuations in NPS in the daily lives of patients…
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Qualitative data collected with an evaluation form to assess the experience and
acceptance of the wearables and ESM by patients with dementia and their primary
caregivers.
Secondary outcome
Biometric data (i.e. blood volume, skin conductance, body temperature, and
motion/activity) derived from the smartwatch and behavioural data derived from
the experience sampling questionnaire.
Background summary
Dementia is often primarily considered a cognitive disorder, but nearly all
individuals with dementia exhibit neuropsychiatric symptoms (NPS), such as
depression and anxiety, at some stage of the disease. NPS are associated with
an increased risk of dementia progression, a higher rate of cognitive decline,
and high caregiver burden. In the memory clinic, NPS are measured with
subjective questionnaires that are administered at one specific moment in time,
which do not take daily fluctuations over time in NPS into account. This
hampers tailored treatment of NPS. It is our hypothesis that apps and wearables
enable continuous (passive) health monitoring and more objective measurements
of NPS during daily life.
Study objective
Our main objective is to investigate the feasibility of measuring NPS in daily
life with experience sampling and wearable technology. Our secondary objective
is to investigate the presence of and fluctuations in NPS in the daily lives of
patients with dementia.
Study design
This is an observational study. Patients with dementia and their caregivers
will be monitored for 14 consecutive days using experience sampling and smart
watch technology. Biometric data will be continuously collected with the
Empatica EmbracePlus. This smartwatch has a PPG sensor, EDA sensor, peripheral
thermometer, accelerometer, and gyroscope in order to collect respectively
information about the blood volume, skin conductance levels, body temperature,
and motion/activity levels. Behavioural data will be collected using experience
sampling in the caregiver. A questionnaire consisting of six to eight questions
will be randomly administered to the caregiver seven times per day. An
evaluation form will be administered to the patient and caregiver after the
observation period.
Study burden and risks
Participants will be continuously passively monitored for 14 consecutive days
with a smartwatch, and caregivers will be prompted to answer six to eight
questions seven times a day on their smartphone during this 14-day period. Both
methods are non-invasive. It might occur that the wristband of the smartwatch
causes some discomfort in patients, and/or that the caregiver questionnaire is
prompted at an inconvenient time during the day. The burden, however, is
minimal. There is no direct benefit for participants.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
- >=18 years old
- Legal capacity
- Patient and primary caregiver are able to read Dutch
- A clinical dementia diagnosis
- Symptoms of depression and/or anxiety are present as indicated by the primary
caregiver on the Neuropsychiatric Inventory
- Patient and primary caregiver live in the same house
- Primary caregiver is in possession of/- and makes use of their smartphone on
a daily basis
- Participants are available for 14 consecutive days without interruption
Exclusion criteria
- Other conditions (e.g. neurological or psychiatric) or medication that may
affect anxiety and/or depression
- Other conditions or medication that are known to affect skin conductance,
body temperature, and motion/activity levels
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84028.078.24 |