Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05207930 |
Other study ID # |
G-UAMH |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 1, 2022 |
Est. completion date |
May 14, 2022 |
Study information
Verified date |
October 2021 |
Source |
The Hong Kong Polytechnic University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Background: Cognitive frailty is an at-risk state of dementia that it can be reversed by
manipulating the lifestyle factors, such as cognitive activity and nutrition/dietary pattern.
Their protective effects depend on a prolonged adherence to these factors. However, in the
literature, most of the cognitive interventions are centred-based and supervised. Nutrition
intervention depends on the provision of supplement or a complimentary supply of food. There
is a lack of interventions with components of sustaining cognitive and nutrition training
effect for the community-dwelling older people with cognitive frailty in home settings.
Objectives: This study aims to examine the feasibility and preliminary effects of a gamified,
home-based, cognitive-nutritional training (GAHOCON) programme for community-dwelling older
people with cognitive frailty on protective diet adherence, cognitive function, frailty
nutrition, and body composition.
Description:
Methods: This study employs a pilot randomized controlled trial design. Recruitment will be
conducted in elderly community centres. Participants who are aged ≥ 60 years,
community-dwelling, and having cognitive frailty will be recruited. Participants will be
randomized into either intervention or control group at a 1:1 ratio by permuted block
randomization with a block size of 8 people. In the intervention group, participants will
attend both centre-based training for one month and home-based training for 2 months. Health
education on cognitive frailty and nutrition are included in the centre-based training.
GAHOCON is included in the home-based training. The gamified cognitive-nutritional training
employs digital gaming technology to develop a programme by combining cognitive training and
nutrition education to promote the health of older people cognitive frailty. In the control
group, participants will attend only the centre-based training. For the outcomes, this study
will measure the feasibility in terms of the willingness of participants to be randomized,
study participation rate, follow-up rates, response rates to questionnaires, adherence rate,
level of participation of the tablet-based training, and time needed for data collection.
Adherence to protective diets, cognitive function, frailty, nutrition, and body composition
will be measured at baseline (T0), immediately after the completion of the intervention (T1).
Convenience sampling will be employed to recruit 30-40 subjects for pilot testing.
Feasibility indexes will be reported by descriptive statistics, such as mean with standard
deviation and frequency with percentage. To test the hypothesis on the effects, a
non-parametric test (i.e., Wilcoxon Signed-rank test) will be used to compare the outcome
variables across time points to test the within-group effect in both groups separately. The
level of significance was 0.05.
Significance: If this intervention is feasible and effective, this is going to provide a
first of its kind home-based intervention to promote both cognitive functions and modify the
dietary pattern of older people with cognitive frailty. First, it changes the cognitive
training mode from a centre-based and supervised one to a home-based, self-paced, and
tele-monitored one. Home-based training enables a more sustainable engagement of training for
older people. This is particularly important during the COVID-19 pandemic period when all the
elderly centres are closed. Home-based interventions are more accessible and convenient. It
also solves the problem of space limitation in elderly centres in the community that more
beneficiaries can be covered in space-limiting elderly centres. Second, it changes the mode
of nutritional intervention from a supplement-based one to a daily-diet-based one. This
intervention could enhance the nutrition and change their dietary pattern of
community-dwelling older people with cognitive frailty by engaging them to protective diets,
which ensures the sustainability of the beneficial effects of the protective diets towards
cognitive frailty. Third, it changes the training mode from a training- and learning-oriented
one to a gaming-oriented one. It brings more joy to community-dwelling older people even at
the time when they are at home. It also fosters training adherence.