The primary objectives are to examine both the (cost-)effectiveness of an innovative 1-year lifestyle intervention on lifestyle change measured by the validated Lifestyle for Brain Health Score (LIBRA) in older adults with a subjective cognitive…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Risicofactoren voor dementiebij mensen met geheugenklachten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be change in participants* dementia risk profile as
measured by the LIfestyle for BRAin Health (LIBRA) score between baseline and
12 months.
Secondary outcome
Secondary outcomes include cognitive functions (episodic memory, executive
functions, information processing speed, and attention). Other secondary
outcomes include measures of body mass index (height and weight), office
systolic and diastolic blood pressure, and lab measures including cholesterol
levels (total, HDL, LDL, triglycerides), HbA1c levels, creatinine-based eGFR
levels. Smoking, alcohol intake and current relevant medical conditions
(coronary heart disease, kidney disease, type 2 diabetes, depression, hearing
loss, sleep disorders) will be assessed through self-report. Additional
questionnaires include health-related quality of life and capabilities,
instrumental activities of daily living, health locus of control,
self-efficacy, mastery, healthy diet, physical activity, cognitive stimulation,
stress, and depressive symptoms, sleep quality, social support and feelings of
loneliness, and lastly knowledge on dementia risk and protective factors. For
cost-effectiveness, questionnaires on resource utilization, medical
consumption, and productivity costs are administered. Additional measures
include change in diagnosis (if applicable), demographics (age, sex,
educational level, socioeconomic position (household income), paid/voluntary
work hours, ethnicity, marital status, living situation), medication use,
hearing loss. For process evaluation, questionnaires and interviews are
administered on implementation, mechanisms of impact and contact (e.g.,
appointments with lifestyle coach, use of the breinzorg.nl self-management
tool, use of the voucher program, experiences and usefulness, etc.).
Background summary
Dementia prevention through lifestyle has much potential but is not implemented
in routine care. Patients referred to memory clinics, such as people with mild
cognitive impairment (MCI) and subjective cognitive disorder (SCD), are at high
risk for dementia and tend to have a worse health and lifestyle profile. While
they might greatly benefit from lifestyle changes, there is no offer to help
them make those changes.
Study objective
The primary objectives are to examine both the (cost-)effectiveness of an
innovative 1-year lifestyle intervention on lifestyle change measured by the
validated Lifestyle for Brain Health Score (LIBRA) in older adults with a
subjective cognitive disorder (SCD) and mild cognitive impairment (MCI); and to
identify possibilities, barriers, and facilitators for sustainable
implementation of the lifestyle intervention.
Study design
Multicenter, randomized controlled trial comparing Group A (tailored lifestyle
intervention) with Group B (general health advice)
Intervention
Participants are randomly allocated on a 1:1 ratio to participate either in
Group A (tailored lifestyle intervention) or Group B (general health advice)
for a duration of 12 months. The lifestyle intervention comprises three parts
1) Lifestyle coaching, 2) a voucher program, and 3) online self-management.
Group B will receive general health advice.
Study burden and risks
- Study participation might be beneficial, as it can improve brain health and
overall health.
- Drawing blood samples might cause mild pain and sometimes a bruise.
- Measurements may take some time, therefore also possible to fill out online.
- Sports activities performed as part of the study may increase chances of
injuries or tripping.
- Intervention based on motivational and educational approach, no participant
will be forced to follow certain guidelines.
Dr. Tanslaan 12
Maastricht 6229ET
NL
Dr. Tanslaan 12
Maastricht 6229ET
NL
Listed location countries
Age
Inclusion criteria
1) Being >=50 years;
2) Having a diagnosis of SCD or MCI;
3) Having at least two modifiable risk factors for dementia
Exclusion criteria
1) Having a diagnosis of dementia;
2) Conditions affecting safe and continuous engagement in the intervention
(e.g. under treatment for current malignant diseases, major psychiatric
disorders (e.g. major de-pression, psychosis, bipolar disorder), other
conditions preventing co-operation as judged by the local study nurse or
consulted physician at the local study site;
3) Participation in any other intervention study at time of pre-screening.
4) Insufficient understanding of the Dutch language
Design
Recruitment
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 | NL86513.068.24 |