2.1. Study design and objectives
This study was conducted from April 2021 to December 2021 as a prospective, parallel-group, a randomized controlled trial. The aim was to explore the feasibility and effects of Wechat official account network intervention on family caregivers of people with dementia on positive emotion (the primary outcome), caregiver competence,caregiver satisfaction (the secondary outcomes) immediately post- intervention (T1) and at the 3-month follow-up (T2), compared with the controls. All data were entered by a research assistant who was blinded to the randomization and allocation results.
2.2. Participants
The participants were family caregivers of people with dementia. Multiple strategies were used to recruit participants from community centers, the inpatients and outpatient clinics. The criteria for participation included: (a) being 18 years or older; (b) having been providing care for at least 3 months prior to recruitment; (c) being able to use a smartphone; (d) being informed consent and voluntary participation in the investigation. A family caregiver is defined as an unpaid individual who has a significant personal relationship with the person with dementia and is involved in assisting him/her with activities of daily living. Excluded were those with (a) a history of mental disorders; (b) serious or chronic pain and/or physical diseases such as cancer and cardiovascular disease; and/or (c) who are participating in other intervention. Randomization was conducted independently by a research assistant using the random numbers table generated by SPSS 18.0 and was not disclosed until the eligible participants completed baseline assessment and signed the informed consent form. Attrition in this study was referred to both dropouts (participants no longer participating in any research-related activities after randomization) and loss of follow-up.
2.3. Sample Size Calculation
According to the study of Aihua Yao et al [20]. The mean score of PAC was 30.52±4.38 in the experimental group and 27.13±4.78 in the usual care group after intervention. The sample size was calculated using PASS 11 software, using the two-group independent mean method to calculate the sample size of experimental group and control group N1=52, N2=52 (Test level α=0.05, test efficiency 1-β=0.95, ratio r=1). Considering the problem of lost follow-up, the sample size was increased by 10% to determine the final sample size of the experimental group N1=58, and that of the control group N2=58.
2.4. Intervention
The control group: usual care (home visits by traditional community workers, telephone follow-up by hospital nurses). The intervention group according to the three dimensions of PAC model: quality of caregiver/care receiver daily relationship, caregiver’s feeling of accomplishment, and the meaning of the caregiver’s role in daily life. Thus, the intervention content is divided into three areas: caring knowledge and skills, communication skills, and positive psychological support. The three dimensions of PAC model( Fig 1) are important variables of the intervention content of wechat public account. (a)PAC model emphasizes that caregivers build a good relationship through emotional communication and effective communication in the process of care can enhance the feelings of both sides. (b)The sense of caregiver’s accomplishment refers to the sense of competence and self-efficacy generated in the process of taking care of patients, which is a happy or successful feeling because their own value has been affirmed. Therefore, the intervention content of wechat public account should provide professional disease knowledge and skill guidance, and teach caregivers to deal with patients' mental and behavioral abnormalities. (c)The dimension of the meaning of the caregiver’s role in daily life emphasizes to enrich caregivers' daily life. Therefore, the intervention content of wechat public account should provide positive psychological support to improve caregivers' happiness and willingness to continue caring.
As a result of the symptom of dementia can be summed up 3 respects: living ability drop, abnormal mental behavior, cognitive obstacle. Therefore, the dimension of caring knowledge and skills includs Care knowledge, ability to live care, mental and behavioral disorders care, and cognitive impairment care. The final intervention content includs 6 areas: Care knowledge, ability to live care, mental and behavioral disorders care, cognitive impairment care, communication skills, and positive psychological support. Push one area content every two weeks. The researchers taught themselves and created an wechat official account with the name "Home of dementia Caregivers". The intervention content will be edited and written by the researcher. After discussion, the research group members will re-check and upload the content to the wechat public account after passing the examination.
The intervention period of this study was determined to be 3 months. The project researcher instructed the caregivers to open wechat, search and follow the public account "Home of Cognitive Caregivers" created by the project. The researcher introduced the usage method of the wechat public account to the caregivers and the way to visit the relevant content. If there were any incomprehension, the researcher would explaine them one by one. After the instruction, caregivers will be invited to demonstrate the operation process of wechat public account to the project researcher. If caregivers still have difficulties in using the account, they will be instructed again until they can master and use the account well. Then the researcher will add caregivers to the wechat group, which can urge and remind caregivers to check the wechat public account content, also can facilitate caregivers to exchange experience with each other. The project researcher check the reading status of caregivers in the background of wechat official account. The numbers of views and reads have become important criteria by which to judge the attention paid to articles. If caregivers do not read in time, the researcher can remind caregivers to check the content of wechat official account by phone or wechat group, or directly send the content of wechat official account to the wechat group for caregivers to read.
2.5. Ethical considerations
Ethical approval for this study was obtained from the ethics committee of Affiliated Hospital of Zunyi Medical University. Before randomization, written consent was sought from the family caregivers to participate in the study on a voluntary basis. Each participant was allowed to clarify questions about the purpose and procedures of the study. The participants were given assurances that their identity and the personal information that was collected would remain confidential, and that they had a right to withdraw from the study at any time.
2.6. Measures
The family caregivers were invited by the trained research assistant to complete a set of outcome measures (described below) at baseline (T0), immediately after the intervention (T1), and at the 3-month follow-up (T2).
the primary outcome: Positive Aspect of Caregiving (PAC)
The caregiving positive emotion was assessed using the Positive Aspect of Caregiving (PAC) [21]. This scale is composed of 9 items, including two dimensions: self-affirmation and life outlook. The total score ranges from 9 to 45, and the higher scores indicating higher the level of positive feelings. The Total Cronbach's α coefficient of PAC scale is 0.90, in which the Cronbach's α coefficient of self-affirmation dimension is 0.89, and the Cronbach's α coefficient of life outlook dimension was 0.83. The PAC scale is a psychological assessment tool with good reliability and validity, which can be used in the study of caregivers of dementia patients.
The secondary outcome: Caregiver Competence Scale (CCS)
The sense of competence experienced by the caregiver was measured using the Caregiver Competence Scale (CCS) [22]. Cronbach's α coefficient is 0.81. This scale, composed of 4 items, measures the caregivers’ perceived competence of their own performance in the caregiving tasks, with a maximum score of 16 points and higher scores indicating more feelings of competence: (a) acquired knowledge to deal with difficult situations; (b) overall feelings of being a good caregiver; (c) feelings of competence; and (d) feelings of self-confidence.
The secondary outcome: Revised Caregiving Satisfaction Scale
The caregiving satisfaction with the care provided was assessed using the Revised Caregiving Satisfaction Scale (RCSS) [23]. Cronbach's α coefficient is 0.81.This scale is composed of 6 items, evaluating different positive aspects of caregiving: (a) global satisfaction helping the relative; (b) feeling closer to the patient; (c) enjoying being with the patient; (d) boosting the caregiver’s self-esteem; (e) delighting in the patient’s pleasure; and (f) giving meaning to the caregiver’s life. With a maximum score of 30 points, higher scores in the RCSS indicate more feelings of satisfaction.