The overall aim is to investigate whether a coach-supported mHealth intervention for lifestyle improvement can reduce the risk of dementia in those with low SES and/or a migration background aged 50-75 years. The specific objectives are to…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This is a type 2 hybrid implementation-effectiveness randomised controlled
clinical trial. There is a primary effectiveness outcome and there are several
implementation outcomes.
- Effectiveness: composite score of systolic blood pressure, LDL-cholesterol
and BMI. We will use the z-score of the difference between baseline and 12
months follow-up values to be analyzed as continuous variables, as previously
done in the HATICE trial.
- Implementation of the mHealth application: Since the different implementation
outcomes will have to be weighed against each other, we will measure multiple
aspects of implementation using mixed methods.
o Acceptability: user-friendliness and credibility (qualitative research
methods).
o Adoption: quantitative analysis of the utilisation, usage and uptake of the
mHealth intervention.
o Appropriateness: qualitative analysis of the perceived fit or relevance of
the mHealth intervention in the target population.
o Feasibility: qualitative analysis to what extent the mHealth application can
be carried out in a low socio-economic setting and in a population with a
migration background.
o Fidelity: qualitative evaluation of the degree to which the mHealth
application is implemented compared to the original design.
o Implementation cost: analysis of the implementation costs will be part of a
health economic analysis.
o Sustainability: quantitative evaluation of the extent to which the mHealth
application is being used during the 12 months of the implementation trial.
Secondary outcome
- Change in CAIDE and LIBRA dementia risk score
- Change in individual modifiable components of the CAIDE and LIBRA risk score
(i.e. blood pressure, BMI, total cholesterol, physical activity)
- Disability (questionnaire: WHO Disability Assessment Schedule 2.0 (WHODAS
2.0, 12-item))
- Depressive symptoms (questionnaire: Geriatric Depression Scale 15-item
(GDS-15))
- Self-efficacy (questionnaire: Partners In Health (PIH))
- Cost-effectiveness
- Intervention costs
- Cognitive functioning, assessed with culturally-sensitive short cognitive
test battery
- Digital measures for social daily functioning measured by BeHapp (remote
behavioural monitoring app). Only in a subgroup of participants willing to
install the BeHapp app; separate consent will be asked on the informed consent
form.
Background summary
Dementia is a growing public health problem as its prevalence is expected to
rise the coming decades, particularly among people of lower socio-economic
status (SES) and/or migration background. Given the absence of curative
treatment, there has been a growing interest in interventions aimed at
dementia prevention to mitigate the rising demand for dementia care. Dementia
is associated with up to 40% modifiable risk factors which may pose an additive
or even synergetic effect on dementia risk. Even a modest reduction of 10% in
these risk factors can significantly decrease the incidence of dementia,
especially in vulnerable communities with lower socioeconomic status and/or a
migration background, where these risk factors are more prevalent. This
prompted the development of a mHealth multidomain intervention, targeting
several risk factors simultaneously. The widespread use of mobile phones,
coupled with increasing access to the internet via mobile devices, presents a
unique opportunity for leveraging mHealth to reach these underserved
populations. Development of this platform is based on the experiences of the
Prevention of Dementia by Mobile Phone Applications (PRODEMOS) project and the
Healthy Aging through Internet Counselling of the Elderly (HATICE) study. The
aim of these studies was to improve healthy lifestyle for the prevention of
dementia and cardiovascular disease in a middle-aged to elderly population,
delivered through a coach-supported app. In the MIND-PRO project we will built
on the lessons learned from PRODEMOS and HATICE to further adapt a mobile phone
application and tailor it to a population with a migration background and/or
low-SES in the Netherlands.
Study objective
The overall aim is to investigate whether a coach-supported mHealth
intervention for lifestyle improvement can reduce the risk of dementia in
those with low SES and/or a migration background aged 50-75 years.
The specific objectives are to investigate:
- The effectiveness of a coach-supported mHealth intervention for lifestyle
improvement to reduce the risk of dementia in those with low SES and/or a
migration background aged 50-75 years.
- The implementation of this blended mHealth intervention for dementia
prevention, operationalised as the acceptability, adoption, appropriateness,
feasibility, fidelity, cost, and sustainability.
Study design
The study is a single-centre, investigator initiated, prospective, open-label
blinded endpoint randomized controlled trial with 12 months intervention. The
study will be conducted in the Netherlands. We will test a culturally-sensitive
blended mHealth intervention in a mixed population of vulnerable persons with
low SES and/or a migration background. We will use a type 2 hybrid
implementation-effectiveness design for a proof of concept study on both
effectiveness and implementability of a blended mHealth intervention using a
composite of three objectively measurable dementia risk factors as a composite
effectiveness outcome.
Intervention
Participants randomized to the intervention arm will have access to an app that
facilitates self-management of dementia risk factors (obesity, physical
inactivity, hypertension, hypercholesterolemia, and active smoking). After
secure login, the app shows the participants* own dementia risk profile,
created through baseline measurements. Participants can set goals for lifestyle
change, monitor these goals and enter self-measurements of for example weight,
blood pressure and exercise. Furthermore, the platform facilitates an
environment with evidence-based education modules (both static and
interactive), educational videos which will be developed within the project and
news items that are arranged according to personal risk factors. The
participants will be supported by an experienced lifestyle coach trained in
motivational interviewing who will be matched to the ethnicity of the
participants as much as possible. The control condition will be a static app
without coach or interactive features, with general health advice. The mHealth
platform will be built in accordance with the highest security requirements in
healthcare. It will comply with NEN 7510, the Health Insurance Portability and
Accountability Act (HIPAA) and General Data Protection Regulation (GDPR).
Study burden and risks
The risks of participating in this study are negligible as it is a non-invasive
and minimally burdensome study which may lead to a healthier lifestyle,
potentially reducing the risk of dementia. There will be three site visits in
total, including screening, baseline, and final visits. These visits can occur
either at the research site or at the participant's home. Participants are
required to provide blood samples (finger-prick) on two occasions (at t0 and
t12) and will undergo physical examination (blood pressure and weight
measurements) during the visits. Additionally, participants will engage with
the intervention platform, which may require them to spend variable amounts of
time on the app according to their preferences. The use of the intervention
platform is expected to not involve any other health risks than the risks that
older individuals generally experience with an active lifestyle. The
intervention platform aims to support a healthier lifestyle and doesn't replace
primary care, with the assigned coach overseeing goal-setting and safety. The
intervention focuses on non-therapeutic aspects and does not involve
investigational treatments.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Age >= 50 years under 75 years;
- Basic level of literacy in Dutch;
- Possession of a smartphone;
- Turkish or South-Asian Surinamese background; OR Dutch background with low
SES background, operationalised using educational level and occupational
status.
- Increased risk of dementia based on:
1. >= 1 dementia risk factors defined as: hypertension, dyslipidaemia, Diabetes
Mellitus, Active smoking, Overweight, Lack of physical exercise, Depression
2. OR Manifest cardiovascular disease, as diagnosed by specialist or general
practitioner
Exclusion criteria
- Previously diagnosed with dementia by a specialist or general practitioner
- A score below the cut-off score of 21 on the Rowland Universal Dementia
Assessment Scale (RUDAS), a validated dementia screening method specifically
developed to be less susceptible to cultural, linguistic, and educational
biases. The RUDAS is available in multiple languages, including Dutch and
Turkish.
- Any condition expected to limit 12 months compliance and follow-up, including
metastasised malignancy or other terminal illness
- Any impairment interfering with operation of a smartphone
- Participating in another RCT on lifestyle behavioural change
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 | NL84958.018.23 |