The objective is to validate the NESTORE Platform in relation to three main evaluation criteria: For (1) Feasibility, we will evaluate the validity and the appropriateness of the procedures for the proposed intervention. For (2) Usability and (3)…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
General prevention for maintaining health
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility assessment is done with log files reporting number, type, severity
and cause of each problem encountered. Usability and Acceptance assessment is
done with the score on respectively the System Usability Scale and the
Technology Acceptance Model for the complete NESTORE Platform and for each
single component in the different phases of use: Installation, Set-up, First
use, Extended use.
Secondary outcome
For Feasibility, the secondary outcome is related to the preliminary assessment
of efficacy, i.e. the possible improvement in the NESTORE well-being domains.
For Usability, the secondary outcome is assumed to be the rate of users
willingly to continue the intervention after the study (assessed 2 weeks after
the conclusion of the study).
For Acceptance, the secondary outcome measures are:
- the drop-out rate (% of users abandoning the study because of lost interest)
- the rate of users continuing the intervention after the study (assessed 2
weeks after the conclusion of the study).
Background summary
As people generally live longer, maintaining cognitive and physical autonomy of
older adults is a key challenge that all modern societies must face. Nowadays,
technology-based interventions to improve health care and to promote healthy
lifestyles are a tangible reality and they represent an important opportunity
to foster healthy aging at a larger scale. The NESTORE project aims to create
an ecosystem of coaching services for promoting *countermeasures* to the
physiological decline related to aging, with the use of different
ICT-components which together form the NESTORE Platform.
Study objective
The objective is to validate the NESTORE Platform in relation to three main
evaluation criteria: For (1) Feasibility, we will evaluate the validity and the
appropriateness of the procedures for the proposed intervention. For (2)
Usability and (3) Acceptance, we mean to assess respectively the usability and
acceptance/compliance of the NESTORE Platform both as a whole and in each
single component during the different phases and according to the applicable
methods and norms.
Study design
Feasibility study of a multi-centre randomized prospective intervention study.
Intervention
ICT-mediated coaching activities to maintain or improve state in four domains:
physical, nutritional, cognitive and social
Study burden and risks
The risks associated with participation can be considered small. The NESTORE
Platform meets the safety requirements for such equipment. In term of use
safety, the NESTORE Platform will warn about using the systems when the user is
doing other activities demanding his/her attention (e.g. driving). The advices
and suggestions of the system are based in recommendations made by scientific
organizations and are not expected to suppose additional risks to participants.
Participants can choose to (not) use all and any of the devices, as their usage
is a study parameter. The burden for the participants lies in the installation
of the NESTORE Platform (they need to be at home during installation) and the
measurements that need to be done. However, with a respectful and personalized
approach, these activities can even be perceived as a pleasant social activity.
This notion was shared by the attendants of the co-design sessions we organized
in the senior centres. Here, it was underlined that it is important to see the
participants as equal partners in this research, rather than subjects, as they
can assist us in improving the NESTORE Platform (only the intervention group),
while getting in insight into their own health (both intervention and control
group). We aim to make this study a pleasant project with the help of the
involved senior centres Seniorenwelzijn and SooS Blauwhuis, with a dedicated
NESTORE group, to make lasting participation more likely.
Coolhaven 96a
Rotterdam 3024 AG
NL
Coolhaven 96a
Rotterdam 3024 AG
NL
Listed location countries
Age
Inclusion criteria
Age: between 65 and 75 years.
Community dwelling, living in their own home.
Independent for all instrumental activities of Lawton & Brody index (phone use,
shopping, preparing meals, housekeeping, laundry, transportation, use of
medication, handle finances)
Physically high functioning, with at least a score of 9+ points in the Short
Physical Performance Battery.
Preserved cognition, with at least a score of 24 points in the Mini Mental
State Examination (MMSE).
Able to use information and communication technology devices. With enough
skills to install apps and shoot pictures in a smartphone.
Availability of the minimum technical system requirements at home: WIFI
connection and a tablet or smartphone with Android 7.0 or newer and Bluetooth
connectivity.
Voluntarily agreeing to participate providing informed consent.
Exclusion criteria
Persons involved in another clinical trial.
Persons reporting deficient vision.
Persons reporting deficient hearing.
Presence of 2 or more symptoms of the Geriatric Depression Scale.
Presence of the following chronic conditions diagnosed by a doctor:
cardiovascular, metabolic, neurologic, immunologic, respiratory, kidney
diseases or diabetes in treatment with insulin. Note: Persons with hypertension
under pharmacological control, hypercholesterolemia, hypertriglyceridemia,
arthrosis, diabetes not treated with insulin, osteoporosis or constipation can
participate in the study.
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 | NL71590.078.19 |