An Intervention Effect Study of a Mobile Medical Supportive Care Program for Family Caregivers With Dementia Combined With Diabetes: a Randomized Controlled Trial
Phase: NA
Conditions: Diabetes, Senile Dementia, Alzheimer Type
Sponsor: Yuanjiao Yan

The research plan
Identifiers: NCT06785857
Unique Protocol ID: K2021-05-024
Brief Title: A Study of Mobile Medical Supportive Care Program for
Family Caregivers With Dementia Combined With Diabetes
Date: 2021-5-1
ⅠResearch Background
Alzheimer's disease, a common degenerative disease of the central
nervous system, refers to the overall impairment of intelligence, memory
and personality that occurs in old age (age ≥60 years), manifested by
memory, calculation, thinking, language, orientation and emotional
disorders, as well as personality changes, and a decline in the ability to
engage in social activities and the ability to live on one's own. The
number of dementia patients in China accounts for about a quarter of
the global population, making it the country with the largest number of
dementia patients in the world. Studies have found that type 2 diabetes
is
highly
susceptible
to
the
development
of
dementia
due
to
hyperglycemia and insulin resistance, and the risk of vascular dementia
in diabetic patients is 2.27 times higher than that in non-diabetic
patients. Alzheimer's patients with comorbid diabetes are at high risk for
physical and mental health risks due to cognitive impairment and mental
and behavioral abnormalities, and are almost incapable of self-care, and
are heavily dependent on their caregivers. Caregivers are faced with
complex clinical symptoms such as diabetic foot and neuropsychiatric
manifestations of dementia, and may even develop a sense of despair

and fear. The provision of holistic, continuous, professional and
personalized care services for caregivers is an urgent issue that needs to
be addressed.
ⅡPurpose of Research
This project aims to build a mobile health supportive care program
for family caregivers with dementia combined with diabetes, and to
evaluate the clinical application effect of the mobile health supportive
care program for family caregivers with dementia combined with
diabetes. The research results will provide more economical and efficient
care guidance for family caregivers, thus improving the overall quality of
care and quality of life for patients with dementia and diabetes.
ⅢResearch Method
（1）Object of Study
1）Source of the study subjects and the sampling methods
The convenience sampling method started from May 2022 to the
end of the sample number, and family caregivers with dementia and
diabetes in 5 community neighborhood committees (cities) and 10
villages (rural areas) of a community health service center that met the
inclusion criteria were selected.
2）Inclusion criteria for the study subjects
Caregivers:
Carers have legal kinship with the patient (such as spouse, children,
or siblings), nannies and hourly workers who do not charge care fees;
work 8 hours / day and 5 days / week for 1 month;
aware, reading and understanding adults;
has at least one smart phone (access to Internet) and skilled use;

informed consent and voluntary participation in investigation and
research.
Care recipients:
meets the diagnostic criteria for senile dementia;
meets the diagnostic criteria for type 2 diabetes;
patients are 60 years old and the resident population in the area.
3）Exclusion criteria for the study subjects
Caregivers:
severe physical or mental illness;
people with drug or alcohol dependence;
caregivers are participating in similar intervention studies.
Care recipients:
Serious physical illness, major disease or terminal disease;
patients with drug or alcohol dependence.
4）Sample size estimation
The sample size is calculated according to the ratio of 1:1 between
the test group and the control group, and the sample size calculation
method of "difference test of two sample means comparison" is used.
The calculation formula is:
Based on the literature review, with the caregiver care burden as
the main outcome measure of this study, n1 and n2 were the required
sample
size,
respectively;
α
=0.05,
β
=0.1,
two-sided
test,
μ0.05/2=1.96,μ0.1=0.282, mean difference δ = 33.91-27.04=6.87, and
overall standard deviation of the intervention σ =6.85. After calculation,
the sample size of both groups was 22 cases, considering 15% shedding

rate, at least 26 cases in each group, a total of 52 cases. Finally, 30
patients were included in each group, totaling 60 patients.
（2）Research Tool
①General Data questionnaire; ②Caregiver Burden Scale
(Caregiver Burden Inventory, CBI); ③Social Support Rating Scale (Social
Support Rating Scale, SSRS); ④Dementified Caregiver Knowledge
Assessment Scale (Dementia Caring Knowledge Scale, DCKS).
（3）Data Processing and Statistical Analysis
Statistical data was analyzed using SPSS 25.0 software. Quantitative
data were represented by normal distribution (
± s), non-normal by M
(QR); qualitative data by n (%). Quantitative data is designed to compare
two independent samples. If sample data follows normality, independent
sample t-test is used, otherwise Mann Whitney U test is used; for
comparison before and after intervention; if the difference follows
normal distribution, paired t-test is used, otherwise Wilcoxon rank sum
test is used. To compare qualitative data between different groups, use χ
2 test or Fisher's exact test; compare rank data between different groups.
Subject analysis (Per-protocol Subjects Analysis, PP).
四、The Project Involves the Implementation Plan of the Ethical Part

Study subjects, number of cases, intervention methods, enrollment
criteria, and exclusion criteria
There were 60 elderly family caregivers with dementia and diabetes,
and the intervention method was mobile medical supportive care
program. The enrollment criteria were: ①Care nannies and hourly
workers with legal kinship (such as spouse, children or siblings), etc.; ②
worked for 8 hours / day and 5 days / week for 1 month; ③well-aware

and reading and understanding adults; ④has at least a smart phone
(Internet access) and skilled use; ⑤informed consent and voluntary
participation in research. Exclusion criteria: ①Severe physical or mental
illness; ②patients with drug or alcohol dependence; ③caregivers are
participating in similar intervention studies.

Specimens to be collected and the sources of the specimens
No specimens were collected

Recruitment and protection measures of the subjects
①Recruitment: Select family caregivers of elderly people with
dementia and diabetes in 5 community neighborhood committees (cities)
and 10 natural villages (rural areas) in the jurisdiction of a community
health service center that meet the exclusion criteria.
②Protection: Carers have the right to refuse to answer any items
that
cause
psychological
discomfort
and
provide
door-to-door
assessment services whenever possible.

Research risks and preventive measures
No medication or any radioactivity, invasive procedures, and in
principle will not cause any risk or adverse effects on the physical health
of the subject.

The benefit of the study
Participation in this study may help subjects to better understand
the health of their caregivers, and the intervention is expected to
improve their social support function and reduce their care burden and
poor mood. However, it is also possible that participation in this study
did not directly benefit the subjects.


Expsts and compensation for subjects' participation in the project
Throughout the study, the subjects were unpaid and no fees were
charged to the subjects. When the subject is injured by his participation
in this study, the necessary medical measures will be taken for treatment
and compensation will be paid in accordance with the current national
laws. If in this study, lost work or transportation expenses, reasonable
expenses will be compensated.

Information and confidentiality about the subjects
All information concerning the subject's personal privacy will be
kept strictly confidential and only for academic purposes, and will not be
disclosed by any public report of the results of this study. This
information will not be available if necessary except for the ethics
committee and relevant researchers.

Process and procedure for the signing of the informed consent form
①Designated a member of the research group to explain the
purpose, significance and research process of the study to the subjects
and their caregivers (legal guardian or legal representative), do a good
job in communication and coordination, gain their trust, establish a good
cooperative relationship and sign the informed consent form.
②On the principle of the subject to sign together, the investigator
and the subject to sign together. For adult subjects who are capable and
able to identify themselves and are not illiterate, the legal representative
or the legal representative may sign the informed consent, for subjects
without capacity, incompetent, unconscious or illiterate to give informed
consent, after the oral consent, the witness signed the informed consent
on the informed consent form.

③After recruitment, 20% of the subjects were selected from the
population and asked whether they were informed of the study and the
content of the informed consent.