Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04723667 |
| Other study ID # |
0000 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2020 |
| Est. completion date |
June 10, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
Chinese University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to evaluate the effects of a 13-week empowerment-based psycho-behavioral
program to improve neuropsychiatric symptoms, cognitive functions, and health-related quality
of life among persons with mild cognitive impairment. Its feasibility will be first evaluated
in a pilot study and subsequently in a randomized controlled trial (RCT)
Description:
Dementia has become a global pandemic. It affects 50 million people worldwide and this number
is projected to have a three-fold increase to over 150 million by 2050. Dementia is
characterized by a progressive deterioration in cognitive functions that interferes an
individual to live independently. It jeopardizes the quality of life of the sufferers and
their families and poses tremendous economic burden on health and social systems. In 2018,
the total cost incurred by dementia worldwide was up to US$ 1 billion and it was forecasted
to double in 2050. Since dementia is incurable, efforts to mitigate the burgeoning population
of dementia should be directed to its prodromal reversible stage, that is, mild cognitive
impairment (MCI).
MCI refers to the transitional stage between normal age-related cognitive decline and
dementia. It is characterized by cognitive decline in a single or multiple cognitive domains
including memory, executive functions, attention, language and visuospatial skills, but the
ability to engage in activities of daily living is preserved. The global prevalence of MCI is
10 to 20% in persons aged 65 or older, and up to 25.9% for those aged above 80 years.
Current research effort focuses on addressing the cognitive symptoms of persons with MCI
(PwMCI), least attention was paid to the co-existing neuropsychiatric symptoms (NPS). Such
non-cognitive symptoms, indeed, affect persons in different stages of cognitive impairment,
there is no exception for MCI. NPS is an umbrella term that captures psychological and
behavioural symptoms, typical psychological symptoms encompass depression, apathy, and
anxiety, which may cluster into a syndrome and precipitate behavioural symptoms such as
agitation and disinhibition. Two systematic reviews simultaneously reported that up to 85% of
the MCI population are afflicted with at least one of these symptoms, with depression being
the most prevalent followed by anxiety and irritability. Comparing to those without such
symptoms, they tend to have poorer quality of life, more severe functional loss, and with a
fourfold increased risk for progression to dementia.
Despite the fact NPS is highly prevalence among PwMCI, effective management with
comprehensive outcome measurement is yet to be determined. An empowerment-based,
comprehensive multimodal intervention with MCI-specific outcome measurement on overall NPS is
warranted. Such intervention should cover skills compensation with transferral into daily
life, lifestyle reform, strength-based activity, cognitive restructuring, and
disease-specific education. This study aims to evaluate an empowerment-based
psycho-behavioral program on improving NPS, cognitive function and health-related quality of
life among persons with MCI. This is a mix-methods study comprising an assessor-blinded
randomized controlled trial and a descriptive qualitative study
As for the sample size calculation, the sample size of the pilot study was set based on a
general rule of thumb of 30 participants, which has been shown adequate for exploring
feasibility and outcome estimates to inform future trials. Those for the major study, Power
analysis using G*Power was performed to estimate the sample size for the RCT. According to
the result of a systematic review that the pooled effect size of the non-pharmacological
interventions on depression among persons with MCI was 0.47 (Lin et al., 2020), this study
conservatively assumed the effect size of a similar but more comprehensive intervention on
the primary outcome of NPS as 0.4. A sample size of 125 per study group is needed to achieve
80% power at a 5% level of significance, allowing a 20% attrition for a 17-week study.
Block randomization was used to allocate the participants to an intervention group, which
received an empowerment-based psycho-behavioral program, or a control group, which received a
health education program, at 1:1 ratio. The random sequence was generated by a computer
randomization software on randomization.com. Each number was printed on a standard 2cm x 2cm
memo and placed into an opaque and sealed envelope. To assure adequate allocation
concealment, the allocation procedure was conducted by an independent research assistant who
was not involved in this study.
For the quantitative data, all test comparisons were set at two-side at a level of
significance of 0.05. The quantitative data were analyzed by SPSS Statistics (version 27)
according to the intention-to-treat principle. Descriptive statistics were used to summarize
the socio-demographic data, clinical profile, and outcome variables. The similarity of study
groups at baseline was examined using chi-square test for categorical data and independent
t-test for continuous data. All participants were assessed at baseline (T0), immediate
post-test (T1), and four-week post-test (T2) to determine changes in their MBI-C, GDS-SF,
AES, K10, HK-MoCA, MIC, and SF-12v2 scores. A generalized estimating equation (GEE) model was
used to determine between- and within-group differences in outcome variables across three
data collection timepoints. All statistical analyses were two-tailed with a 5% level of
statistical significance. Effect size estimates were calculated for all mean differences
using Cohen's d values, and were classified as negligible (d<0.2), small (0.2≤ d<0.5), medium
(0.5≤d< 0.8), or large (d≥0.8) effects (Lakens, 2013). Post-hoc power analysis was performed
for all outcome variables using G*Power software. Individual semi-structured interviews were
conducted to explore the perceived effects of the psycho-behavioral program and the
qualitative data were analyzed by content analysis.
Lin, R. S. Y., Yu, D. S. F., Chau, P. H., & Li, P. W. C. (2021). An
empowerment-psycho-behavioral program on neuropsychiatric symptoms in persons with mild
cognitive impairment: Study protocol of a randomized controlled trial. Journal of Advanced
Nursing.
