Registration
The protocol for this non-randomized controlled trial is registered at the Chinese Clinical Trial Registry, ChiCTR2300074788 (https://www.chictr.org.cn/). We registered on August 16, 2023.
Aims, objectives,and hypotheses
This protocol describes the design of an innovative dementia literacy intervention program that aims to promote healthy behaviors and prevent dementia using multi-format and multi-themed intervention approaches.
This study aims to:
- Determine the effectiveness of the elderly dementia literacy intervention program, on dementia knowledge literacy, attitude literacy, and self-management behavior literacy.
- Explore the difficulties and challenges of implementing the dementia literacy program among community-dwelling elderly people.
We hypothesized that older adults in the intervention group would report higher dementia knowledge, attitude, and self-management behavior literacy compared to the usual care group after the three-month intervention. Additionally, they would be better equipped for early prevention, timely diagnosis, and management of dementia.
Design
This study will be a non-randomized controlled trial. Two community health service centers in Guangzhou have been selected based on their large numbers of older adult attendees. After sectionalization, participants will receive either the intervention or usual care. The groups will not be randomized considering the physical health status and living convenience of older adults, such as the availability of time and energy to participate in the health literacy interventions at regular intervals throughout the trial.
This study will invite experts specializing in cognitive disorders to evaluate the dementia literacy intervention program. Then, according to expert opinions, the content and form of the intervention will be further modified to ensure the feasibility of the intervention plan. During the formal intervention, the first author will provide intervention measures for the intervention group and be responsible for overall project management, including raining delivery, overseeing the entire trial, and data quality assessment. Additionally, each community will have a project team consisting of a senior community nurse and four research assistants. The project team will primarily be responsible for patient recruitment, assisting in the intervention process, and data collection. Project team members will undergo standardized training before the intervention and data collection to ensure the quality of the intervention trial and data collection. The trial has been approved by our Ethical Committees and was registered with the Clinical Trial Registry. The study design is outlined in Figure 1.
Participants
The participants who meet the following criteria will be recruited: (a) age ≥ 60 years, (b) residing in the community for at least three months, (c) can participate in the program for one hour every two weeks, (d) having no communication or mobility barriers and being able to cooperate in completing the study, and (e) being willing to participate in this survey with informed consent. Exclude criteria will be: (a) diagnosed with dementia, (b) suffering from a severe mental illness or diagnosed with major depression, (c) with a short-term history of acute cardiovascular or cerebrovascular disease, and (d) no mobile phone and other communication devices to use WeChat.
Recruitment
During this study, recruitment posters will be distributed in places frequented by older adults, such as the community committee, community health service center, and exercise squares. Simultaneously, pamphlets containing relevant study information will be distributed to elderly residents, and recruitment information will be shared within community WeChat groups. The aim is to recruit 84 eligible participants willing to participate in the study.
Sample size
The sample size was estimated according to the formula: The n is the sample size;𝜇a is the u-value corresponding to the Type I error probability; 𝜇𝛽 is the u-value corresponding to the Type II error probability; 𝛿 represents the expected effect size, which is the absolute difference in means between two groups; 𝜎2 represents the population variance and can be estimated using the sample variance, which is the average of the variances of the two groups. α was set at 0.05 and β at 0.10. Referencing the study by Ayisi-Boateng et al. a minimum sample size of 34 cases is needed [34]. The required sample size becomes at least 42 cases after factoring in a 20% dropout rate. We aim to recruit 84 participants for this study, with 42 per group.
Study intervention
Intervention group
According to the definition of dementia literacy, we divide the intervention program into three themes: dementia knowledge, dementia attitude, and dementia self-management behavior literacy [35,36]. The content of the program considers the most recent guidelines, such as “Guidelines for the Prevention and Treatment of Senile Dementia” and “Chinese Expert Consensus on the Diagnosis and Treatment of Alzheimer’s Disease-Origin Mild Cognitive Impairment 2021” [37,38]. Intervention methods include dementia knowledge seminars, dementia knowledge popularization videos, and WeChat group information pushes and question answering. The main contents and arrangements of dementia literacy interventions for older adults are shown in Table 1.
Dementia knowledge seminars: We will hold two dementia knowledge seminars per month in the community, and the theme will focus on one of the three aspects of dementia health literacy. Each seminar will last approximately 45 minutes: 20 minutes for knowledge presentations, 10 minutes for interactive games, 10 minutes for learning assessments such as word matching, and five minutes for participants to share their experiences and insights freely.
Dementia knowledge popularization video: Following the theme of dementia health literacy, two dementia knowledge popularization videos will be created each month. These videos will be distributed in the WeChat groups of the intervention group. Each video will be a maximum of five minutes, with an original content. The presentation format involves lively and vivid image animations combined with explanations in simple and understandable language.
WeChat Group Information Sharing and question-answering:We will set up a dedicated WeChat group to answer participants’ questions about dementia and communicate daily health knowledge together. The group will share dementia literacy-related knowledge tweets weekly, and the tweets are sourced from “Senile Dementia,” “Dementia,” “Alzheimer’s Disease,” “Alzheimer’s Disease Prevention and Treatment Association,” “Chinese Alzheimer’s Disease Association,” and other dementia public sharing platforms and public numbers. We will regularly share videos about dementia, including movies, variety shows, documentaries, and news, to help participants understand and recognize dementia better.
Control group
The control group will receive routine community care services, including regular health follow-ups and physical examinations, written health education, and stylistic health activities. However, they will not receive additional care services related to dementia literacy. The intervention group will receive dementia literacy interventions concurrently with routine community nursing services.
Outcome measures
The program will be evaluated at baseline [T0] and post-intervention [3 months—T1]. The primary outcomes measured at three months will be: dementia knowledge literacy, dementia attitude literacy, and dementia self-management behavior literacy. The primary outcomes will be measured using validated tools.
Dementia knowledge literacy
The Alzheimer's Disease Knowledge Scale (ADKS) will be used to measure the dementia knowledge literacy [39]. The scale contains 30 judgmental right or wrong questions that evaluate the test taker's knowledge of Alzheimer's disease assessment, diagnosis, care, life impact, prevalence, prevention, risk factors, symptoms, treatment, and management. The composite score is calculated by counting the number of correctly answered questions, and can range from 0 to 30. The Cronbach's alpha, retest reliability, and split-half reliability of the scale are 0.71, 0.81, and 0.55, respectively.
Dementia attitude literacy
The Dementia Attitudes Scale (DAS) is used to measure the dementia attitude literacy [40]. It includes 20 items, each assessed on a 7-point Likert scale from 1 [strongly disagree] to 7 [strongly agree], with a total scale score ranging from 20 to 140. The higher the total score, the more positive the attitude toward dementia. The Cronbach's alpha of the value for the scale is 0.83.
Dementia Self-management behavioral literacy
The Chinese version of the Health Promoting Lifestyle Profile-Ⅱ (HPLP-Ⅱ) is used to measure the dementia self-management behavioral literacy of the study participants [41]. The scale consists of 40 items with six dimensions: nutrition (6 items), physical activity (8 items), health responsibility (11 items), interpersonal relationships (5 items), spiritual growth (5 items), and stress management (5 items). The items are scored on a four-point Likert scale from 1 to 4 as “never,” “sometimes,” “often,” and “always,” with a total score range of 40–160. A score of 1–2, 2–3, or 3–4 indicates a low, medium, or high level of health promotion lifestyle, with higher scores indicating a better health promotion lifestyle. The Cronbach's alpha of this scale ranged from 0.63–0.81, with a retest reliability of 0.69.
Data collection procedure
Data collection will be conducted by two community project team members. All participants will complete the sociodemographic questionnaires, ADKS, DAS, and Chinese versions of the HPLP-II. Reassessment data will be collected at the end of the three-month intervention program. Community project members will redistribute the ADKS, DAS, and HPLP-II questionnaires to participants in both the intervention and control groups. Sociodemographic data will include participants' names, contact information, gender, age, employment status, education level, occupation, accommodation, marital status, cohabitation, family relationships, history of relevant illnesses, health status, and experience of dementia exposure. All data will be collected through paper questionnaires completed by the study participants. The project team members will assist those with visual impairments, difficulty writing, or limited education to fill out the forms after obtaining their opinions.
Data analysis
All data will be quantified and entered into a computer to create a database. Two persons will enter the data to ensure correct data entry. Statistical analysis will be performed using the SPSS 27.0 software. All tests will be two-sided and p-values<0.05 will be considered statistically significant. Sociodemographic information, DAS, ADKS, and Chinese versions of the HPLP-II will be described using frequencies and percentages, as well as means and standard deviation. In order to evaluate the effectiveness of the intervention program, t-tests will be used to analyze the differences in dementia literacy between the study participants before and after the intervention.
Ethical considerations
This study has been approved by the Ethical Committees and registered in the Clinical Trial Registry. The study participants will be informed of the purpose and methodology of the study and will be asked to sign an informed consent form before the survey and intervention. Participants and their family members or legal guardians will have the option to cancel their participation in the study at any time. Patient privacy will be ensured at all times.