Preventive intervention of mild cognitive impairment in Anhui, China
| ISRCTN | ISRCTN15775827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15775827 |
- Submission date
- 29/08/2022
- Registration date
- 21/09/2022
- Last edited
- 21/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Background and study aim
Alzheimer's disease (AD) is the most common cause of dementia, a general term for memory loss and other cognitive abilities serious enough to interfere with daily life. AD has become a significant global public health challenge. Early preventive intervention to delay AD onset has become a key measure for many countries worldwide to address the challenge. Mild cognitive impairment (MCI) is the intermediate transition stage from normal cognitive people to AD. Thus MCI is of significant public health significance for preventing AD. Early prevention of MCI for those at risk of MCI is the key to slowing the spread of AD. In this study, the idea of a hierarchical preventive intervention for MCI was applied as a primary prevention strategy, aiming to reduce the MCI risk among older community dwellers effectively and at a low cost.
Who can participate?
People aged 55-75 years with normal cognitive function
What does the study involve?
The MCI risk assessment tool was developed and applied to assess the risk of MCI for older community dwellers. The participants are categorized into three risk groups (high, medium, and low) based on the risk score of MCI. Different lifestyle intervention plans are given to the participants according to their risk group and the sources of the risk. Changes in MCI total risk, somatic function, cognitive function, activities of daily living, and psychological status are evaluated at 8, 16, and 24 weeks after the intervention.
What are the possible benefits and risks of participating?
There are not thought to be any risks involved with participating in the study. A possible benefit could be that participants will develop a healthy lifestyle that has a wide range of benefits and prevents many chronic diseases including AD.
Where is the study run from?
Sample communities in Hefei, Anhui province (China).
When is the study starting and how long is it expected to run for?
March 2020 to December 2023
Who is funding the study?
National Natural Science Foundation of China (China)
Who is the main contact?
Miss Yan Zhang
zhangymail@ahmu.edu.cn
Contact information
Prof Yan Zhang
Principal Investigator
Principal Investigator
Anhui Medical University
81 Meishan Road
Hefei
230032
China
| Phone | +86 (0)551 65116395 |
|---|---|
| zhangymail@ahmu.edu.cn |
Study information
| Study design | Community trial with a cross-over design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Risk stratification and hierarchical intervention strategy for mild cognitive impairment among older community dwellers |
| Study objectives | After the intervention, the subjects will demonstrate lower scores on the total risk score, better levels of somatic function, cognitive function, activity of daily living, and psychological status. |
| Ethics approval(s) | Approved 01/03/2020, Anhui Medical University ethics committee (81 Meishan Road, Hefei, Anhui Province, China; +86 (0)551 65161053; email: not applicable), ref: 20200323 |
| Health condition(s) or problem(s) studied | Mild cognitive impairment (MCI) |
| Intervention | The intervention was divided into two stages. In the first stage, the 24-weeks of intervention were given to the intervention group (community A), and for the control group (community B) only natural development was observed. In the second stage, the intervention was stopped for community A, but only follow-up observation continued; however, the same 24-weeks preventive intervention started for community B. Interventions focused on nine risk factors: social isolation, cognitive reserve, drinking, smoking, hypertension, hyperlipidemia, diabetes, exercise, and depression. The specific intervention list is as follows: Social isolation: High-risk group: 1. Health education (professionals, once a month, 4 times in total) 2. Social engagement (once a month, 4 times in total) 3. Health education (once a month, 4 times in total) Medium risk group: 1. Health education (two lectures by professionals) 2. Social engagement (once every 2 months, two times in total) 3. Health education (twice a month, 8 times in total) Low-risk group: 1. Health education (two lectures by professionals) 2. Health education (twice a month, eight times in total) Cognitive reserve： High-risk group: 1. Memory training (twice a month, eight times in total) (two rounds) 2. Educational activities (twice a month, eight times in total) (two rounds) 3. Educational activities for the elderly Medium risk group: 1. Memory training (once a month, four times in total) 2. Educational activities (once a month, four times in total) 3. Educational activities for the elderly Low-risk group: 1. Memory training (once every two months, two times in total) 2. Educational activities (once every two months, two times in total) 3. Educational activities for the elderly Drinking: High-risk group: 1. WeChat official account push (based on the 5R model, dedicated person responsible, once every 2 weeks, eight times in total) 2. Signing an abstinence pledge (heavy drinkers) 3. Abstinence Self-monitoring Questionnaire (once a month, four times in total) 4. Abstinence Family Member Monitoring Questionnaire (once a month, four times in total) Medium risk group: 1. WeChat official account push (based on the 5R model, dedicated person responsible, once every 2 weeks, eight times in total) 2. Signing an abstinence pledge (heavy drinkers) 3. Abstinence Self-monitoring Questionnaire (once a month, four times in total) 4. Abstinence Family Member Monitoring Questionnaire (once a month, four times in total) Low-risk group: 1. Popular science information push (from Popular Science China, dedicated person responsible, two times in total) 2. Signing an abstinence pledge (heavy drinkers) 3. Abstinence Self-monitoring Questionnaire (once a month, four times in total) 4. Abstinence Family Member Monitoring Questionnaire (once a month, four times in total) Smoking: High-risk group: 1. WeChat official account push (based on the 5R model, dedicated person responsible, once every 2 weeks, eight times in total) 2. Signing a pledge to stop smoking (heavy smokers) 3. Smoking Cessation Self-monitoring Questionnaire (once a month, four times in total) 4. Smoking Cessation Monitoring Questionnaire for family members (once a month, four times in total) Medium risk group: 1. WeChat official account push (based on the 5R model, dedicated person responsible, once every 2 weeks, eight times in total) 2. Signing a pledge to stop smoking (heavy smokers) 3. Smoking Cessation Self-monitoring Questionnaire (once a month, four times in total) 4. Smoking Cessation Monitoring Questionnaire for family members (once a month, four times in total) Low-risk group: 1. WeChat official account push (from Popular Science China, dedicated person responsible, three times in total) 2. Signing a pledge to stop smoking (heavy smokers) 3. Smoking Cessation Self-monitoring Questionnaire (once a month, fourtimes in total) 4. Smoking Cessation Monitoring Questionnaire for family members (once a month, four times in total) Hypertension: High-risk group: 1. Carry out health lectures on chronic diseases (hypertension, hyperlipidemia and diabetes) (professionals give lectures and answer questions, three times in total) 2. Individual medication and dietary guidance (professional doctor is responsible, once a month, four times in total) 3. Personalized exercise prescription (professional sports coach is responsible for it, once a month, four times in total) 4. Health education 5. Dietary records for 3 days (mobile phone photography, once a month) 6. Exercise sharing on WeChat (once a week) 7. Blood pressure self-monitoring (once a day) Medium risk group: 1. Carry out health lectures on chronic diseases (hypertension, hyperlipidemia and diabetes) (professionals give lectures and answer questions, two times in total) 2. Individual medication and dietary guidance (the professional doctor is responsible one time) 3. Personalized exercise prescription (professional sports coach, one time in total) 4. Health education 5. Dietary records for 3 days (mobile phone photography, once a month) 6. Exercise sharing on WeChat (once a week) 7. Blood pressure self-monitoring (three times a week) Low-risk group: 1. Carry out health lectures on chronic diseases (hypertension, hyperlipidemia and diabetes) (professionals give lectures and answer questions, one time in total) 2. Individual medication and dietary guidance (the professional doctor is responsible one time) 3. Personalized exercise prescription (professional sports coach is responsible for it, one time in total) 4. Health education 5. Dietary records for 3 days (mobile phone photography, once a month) 6. Exercise sharing on WeChat (twice a week) 7. Blood pressure self-monitoring (once a week) Hyperlipidemia: High-risk group: 1. Carry out health lectures on chronic diseases (hypertension, hyperlipidemia and diabetes) (professionals give lectures and answer questions, three times in total) 2. Individual medication and dietary guidance (professional doctor is responsible, once a month, four times in total) 3. Personalized exercise prescription (professional sports coach is responsible for it, once a month, four times in total) 4. Blood lipid test (two times in total, with an interval of more than 3 months) 5. Health education 6. Dietary records for 3 days (mobile phone photography, once a month) 7. Exercise sharing on WeChat (once a week) Medium risk group: 1. Carry out health lectures on chronic diseases (hypertension, hyperlipidemia and diabetes) (professionals give lectures and answer questions,two times in total) 2. Individual medication and dietary guidance (the professional doctor is responsible one time) 3. Personalized exercise prescription (professional sports coach is responsible for it, one time in total) 4. Blood lipid test (two times in total, with an interval of more than 3 months) 5. Health education 6. Dietary records for 3 days (mobile phone photography, once a month) 7. Exercise sharing on WeChat (once a week) Low-risk group: 1. Carry out health lectures on chronic diseases (hypertension, hyperlipidemia and diabetes) (professionals give lectures and answer questions, one time in total) 2. Individual medication and dietary guidance (the professional doctor is responsible one time) 3. Personalized exercise prescription (professional sports coach is responsible for it, one time in total) 4. Blood lipid test (two times in total, with an interval of more than 3 months) 5. Health education 6. Dietary records for 3 days (mobile phone photography, once a month) 7. Exercise sharing on WeChat (once a week) Diabetes: High-risk group: 1. Carry out health lectures on chronic diseases (hypertension, hyperlipidemia, and diabetes) (professionals give lectures and answer questions, three times in total) 2. Individual medication and dietary guidance (professional doctor is responsible, once a month, four times in total) 3. Personalized exercise prescription (professional sports coach is responsible for it, once a month, four times in total) 4. Glycosylated hemoglobin test (two times in total, with an interval of more than 3 months) 5. Health education Medium risk group: 1. Carry out health lectures on chronic diseases (hypertension, hyperlipidemia, and diabetes) (professionals give lectures and answer questions, two times in total) 2. Individual medication and dietary guidance (the professional doctor is responsible one time) 3. Personalized exercise prescription (professional sports coach is responsible for it, one time in total) 4. Glycosylated hemoglobin test (2 times in total, with an interval of more than 3 months) 5. Health education 6. Weight monitoring (once a month, four times in total) 7. Dietary records for 3 days (mobile phone photography, once a month) 8. Exercise sharing on WeChat (once a week) Low-risk group: 1. Carry out health lectures on chronic diseases (hypertension, hyperlipidemia, and diabetes) (professionals give lectures and answer questions, one time in total) 2. Individual medication and dietary guidance (the professional doctor is responsible one time) 3. Personalized exercise prescription (professional sports coach is responsible for it, one time in total) 4. Glycosylated hemoglobin test (two times in total, with an interval of more than 3 months) 5. Health education 6. Weight monitoring (once a month, four times in total) 7. Dietary records for 3 days (mobile phone photography, once a month) 8. Exercise sharing on WeChat (once a week) Exercise: High-risk group: 1. Health education (professionals give lectures and answer questions, one time in total) 2. Personalized exercise prescription (professional sports coach, once a month, four times in total) 3. Health education 4. Exercise sharing on WeChat (once a month, four times in total) Medium risk group: 1. Health education (professionals give lectures and answer questions, one time in total) 2. Personalized exercise prescription (professional sports coach, two times in total) 3. Health education 4. Exercise sharing on WeChat (once a month, four times in total) Low-risk group: 1. Health education (professionals give lectures and answer questions, one time in total) 2. Personalized exercise prescription (professional sports coach, one time in total) 3. Health education 4. Exercise sharing on WeChat (once a week) Depression: High-risk group: 1. Mental health guidance by professional doctors (two times in total) 2. Popular science videos pushed to the WeChat official account (from the National Center for Mental Health, eight times in total) 3. Health education Medium risk group: 1. Mental health guidance by professional doctors (two times in total) 2. Popular science videos pushed to the WeChat official account (from National Center for Mental Health, four times in total) 3. Health education Low-risk group: 1. Popular science videos pushed to the WeChat official account (from National Center for Mental Health, four times in total) 2. Health education An individualized intervention plan will be made based on an individual’s personal risk factors (the utmost three risk factors contributing most significantly to the risk scores) |
| Intervention type | Behavioural |
| Primary outcome measure | The change in the total risk score of each individual was used as the main observation index at baseline and at 8, 16, and 24 weeks |
| Secondary outcome measures | 1. Somatic function measured using the results evaluated by neurology professionals at baseline and at 8, 16, and 24 weeks 2. Cognitive function measured using the Mini-Mental State Examination (MMSE) at baseline and at 8, 16, and 24 weeks 3. Activities of daily living measured using the activities of daily living (ADL) at baseline and at 8, 16, and 24 weeks 4. Psychological status measured using the 9-item Patient Health Questionnaire (PHQ-9) at baseline and at 8, 16, and 24 weeks 5. Quality of life measured using the EQ-5D at baseline and at 8, 16, and 24 weeks |
| Overall study start date | 01/03/2020 |
| Completion date | 30/12/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 88 |
| Total final enrolment | 200 |
| Key inclusion criteria | 1. Aged 55-75 years, male or female 2. Owning a smartphone, have Instant Messenger (e.g., WeChat), and can use it proficiently 3. Is a permanent resident of the community and has no plan to leave the community for a long-term residence elsewhere within 1 year 4. Normal cognitive function (MMSE score of 24 or higher) 5. Be aware of the purpose of this study and willing to participate (sign informed consent) |
| Key exclusion criteria | Older adults with MCI or AD at baseline |
| Date of first enrolment | 01/01/2022 |
| Date of final enrolment | 30/03/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Anhui Medical University
81 Meishan Road
Hefei
230032
China
Hefei
230032
China
Sponsor information
National Natural Science Foundation of China
Government
Government
83 Shuangqing Road
Haidian District
Beijing
100085
China
| Phone | +86 (0)10 62327001 |
|---|---|
| bic@nsfc.gov.cn | |
| Website | http://www.nsfc.gov.cn/publish/portal1/ |
"ROR" |
https://ror.org/01h0zpd94 |
Funders
Funder type
Government
National Natural Science Foundation of China
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Results and Publications
| Intention to publish date | 30/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
21/09/2022: Trial's existence confirmed by the Anhui Medical University ethics committee.
