To test the feasibility of supplying a tailored, digital health app, designed to increase insight in how to reduce one*s dementia risk, in the general practice. Secondly, we aim to explore the usability of experience-sampling method (ESM) technology…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility will be evaluated on the basis of: (1) difference in change in
LIBRA scores between groups; (2) use of the health app (percentage of
completers, access to and time spent on app); (3) the number of excluded
individuals and dropouts; (4) participants* understandings, attitudes and views
towards their LIBRA profile and the health app, including their role when
embedding behavior change into everyday life; and (5) perspectives of involved
primary care practitioners on the LIBRA profile and health app in terms of
acceptability, demand, integration and implementation.
Usability of ESM technology will be evaluated based on ESM-derived data points,
response rates and participants* subjective experiences regarding the method
and its feedback.
Secondary outcome
A secondary study endpoint is the frequency and severity of the 12 individual
LIBRA factors present within study participants at baseline and at follow-up.
Background summary
Dementia is an important public health problem in our aging society. As there
is currently no treatment available, attention is shifting towards preventive
strategies. Robust evidence indicates that health and lifestyle factors
influence dementia risk. Yet, these findings have not been translated in public
risk reduction strategies.
Study objective
To test the feasibility of supplying a tailored, digital health app, designed
to increase insight in how to reduce one*s dementia risk, in the general
practice. Secondly, we aim to explore the usability of experience-sampling
method (ESM) technology in this digital health app.
Study design
Primary care-based Proof-of-Concept (PoC) trial with embedded ESM pilot study
Intervention
In the PoC trial, both the intervention (n=90) and control group (n=90) will
get one session of personal face-to-face general practitioner (GP) guidance
about living a brain-healthy lifestyle (based on their individual *LIfestyle
for BRAin health** (LIBRA) score; a validated risk score that assesses how
brain-healthy one*s current lifestyle is, based on 12 modifiable risk and
protective factors for dementia). The intervention group will additionally get
access to the personalized digital health app called MijnBreincoach. This app
provides the user with daily messages (e.g. tip, quiz, challenge, information)
regarding a LIBRA risk or protective factor that the user chose to focus on.
Within the ESM pilot study, one additional group of participants (n=20) will
get access to the MijnBreincoach app but participants will also be asked to
respond to ESM questionnaires and they will receive ESM-based feedback. The
total duration of study participation will be 3 months.
Study burden and risks
The participants need to fill in an online questionnaire at the start of the
study. Afterwards, all participants need to plan one appointment with their GP
or practice nurse. This appointment will consist of a blood pressure
measurement (if no recent measurement is available), and a discussion of the
participant*s LIBRA profile along with personal advice and setting sustainable
and realistic lifestyle goals. After this appointment, the intervention group
will get access to the MijnBreincoach app which they can use on a daily basis
at their own discretion. After 3 months, online questionnaires will be
administered. These are not considered burdensome or stressful. A subsample of
participants (n=10) from the intervention group and ESM-pilot study, and
involved health care professionals (n=4) will be asked to participate in a
short interview at the end of the study. The ESM-group will additionally be
asked to collect ESM data for 6 consecutive days. Specifically, they will
receive a short questionnaire at 10 random moments during the day (between 7:30
AM and 10:30 PM), after which they will receive personal feedback. No negative
effects because of participation are expected, as use of provided information
is at the discretion of the participant and drawn from authoritative public
health resources. Participating in the study has an additional advantage to the
participants. The study will increase knowledge about modifiable dementia risk
factors, give people insight in their individual health profile, and provide
them with strategies and tips to promote their cognitive health.
Dr. Tanslaan 12
Maastricht 6229 ET
NL
Dr. Tanslaan 12
Maastricht 6229 ET
NL
Listed location countries
Age
Inclusion criteria
• Registered with a participating general practice
• Age 40-60 years old on date of consent
• Medically stable
• Proficient in Dutch language
• Access to internet in order to use the smartphone application
• Owns a smartphone
• Presence of any one (or more) of the following risk factors:
o Depression - previous history or active episode of minor depression as
recorded on medical record - if general practitioner deems patient fit to
participate
o Diabetes type 2 (diagnosis e.g. on a diabetes disease register)
o Hypertension
o Obesity (BMI >= 30)
o Current smoker
o Hyperlipidemia
o More than moderate consumption of alcohol (>1 standard unit per day)
o Coronary heart disease
o Chronic kidney disease
o Inactive to moderately inactive lifestyle
o Lack of cognitive activity
o Unhealthy diet
Exclusion criteria
• ¬Active episode of major depression, if general practitioner deems patient
too severely ill to participate, recorded in medical record or assessed by a
validated instrument
• People who are unable to give informed consent
• People who have dementia
• People with certain conditions because of which they cannot make the
suggested lifestyle changes by default (e.g. special dietary requirements due
to e.g. bariatric surgery or coeliac disease); movement constraints (e.g. due
to cerebral palsy or hemiparesis)
• People who have previously used the MijnBreincoach app
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 | NL75147.068.20 |
| Other | NL9773 |