This exploratory mixed methods study was initially conducted from May 2016 to June 2018 in three stages. The first phase of the study was conducted using a qualitative approach to the content analysis methodology to expand and complete the PLST model. Then, in the second stage, the researcher made a multisectional questionnaire using a standard questionnaire and the results of a qualitative study. Finally, the educational intervention was carried out using a pretest-posttest group based on the educational needs of caregivers resulting from qualitative study and within the framework of the PLSTE model with the aim of improving caregivers' practice, caregiving skills, and dealing with CBPWD.
Key informants (14) in the qualitative phase of the study were caregivers of People with Dementia (PWD). Caregivers were people whose patients had a case with a psychiatrist or in an educational hospital. It should be noted that some caregivers were serving at home and some in the elderly nursery homes (primary caregiving). Other informants (14) were those who had somehow entered the course of the disease, including the family of patients. An in-depth unstructured interview was conducted with 29 caregivers as a sample to reach data saturation.
The inclusion criteria of the study were all caregivers who had at least 6 months of experience taking care of people with dementia (PWD). We were interested in participating in the study. We were willing to express their experiences and completed and signed the written consent form. Refusing to collaborate with the researcher and interviewing were exclusion criteria. A total of 33 informants were enrolled in the study, of which four were excluded from the study due to lack of inclusion criteria and non-participation. To select the informants, the scholar referred to accessible and qualified caregivers personally and invited them to participate in the study.
How to Conduct Interviews and Collect Data in the Qualitative Phase
In this study, the corresponding author (SZ) was responsible for conducting the interview. Interviews with participants were done by phone or face to face. Before the interview, caregivers were asked to express their basic demographic information, including age, sex, marital status, level of education, length and hours of caregiving, and previous caregiving experience, as outlined in Table 1. Interviews were conducted only in the presence of the researcher without the presence of others. At the beginning of each interview, the research objectives were explained to the participants, and for the interviews to be recorded, verbal consent was obtained. At the end of each interview, the consent of the participants was recalled according to the issues mentioned in the interview. The interviews started with some questions for more familiarity and a more intimate climate and then continued with asking about the caregiving experience of the informants about taking care of people with dementia (PWD). According to the informants' experiences, the next questions were not predicted, and the patient was asked according to the previous conversation. The interviews were recorded by the recorder and immediately transcribed in Microsoft Word. After transcribing the interviews and reviewing them by the authors, 4 interviews were repeated due to the need to obtain more information from the caregivers.
Sampling Procedure and Sample Size in Quantitative Phase
With the aim of conducting the intervention and determining the sample size in this phase, two groups of family and official caregivers were selected due to limited access to caregivers. The sample size was estimated to be 32 informants by n= (zα/2+zβ) ²S²/d² formula (factor of safety 95% and test coefficient 80%). This number was increased to 38 informants due to reduction during the intervention and in the follow-up phase. The inclusion and exclusion criteria were the same as those in the qualitative phase. To select the samples, the available files of People with Dementia (PWD) in educational hospitals affiliated with Isfahan University of Medical Sciences and psychiatrists' offices were reviewed. Six family caregivers and 32 caregivers working in elderly nursery centers were willing to participate in the study.
According to the first (FZ) and second (SZ) authors’ experiences in conducting qualitative research, they were more involved in data analysis. Interviews were transcribed for analysis using the "new comment" command and Microsoft Word. The text of each interview was carefully studied, and after breaking the text, first-level codes were extracted. Primary codes were categorized based on similarities and differences, and by titling each class and repeating the classification and merging of similar codes and adding newly generated codes, second-level codes were extracted. Finally, the main themes were produced and classified. When all the data were coded and agreed upon for the classes, each class was also examined for saturation.
Scientific Trustworthiness of the Results
Regarding trustworthiness (14, 15, 16), credibility, dependability, conformability, transferability, and authenticity were applied. To apply trustworthiness in the whole study, the researcher attempted to collect and analyze appropriate data with the maximum variety (official and family caregivers) according to Lincoln and Guba criteria to reach saturation. The process of data analysis was a reciprocal continuous rotational comparison, and to control any ambiguity, the data were controlled by the members themselves (Member Check). The codes obtained from the Peer Check and External Check methods by the authors' team were revised and modified in the presence of five experienced professors in the field of qualitative studies and psychiatric professors (14) (17).
Expansion of the PLST Model
By analyzing qualitative data, the researchers eventually created a new class and intervention for the PLST model by using one of the generated classes.
Educational Intervention based on PLST Extended Model
The educational sessions were held in the halls of the two elderly nursery centers of Sadeghieh and Rangin Kaman-sefid in Isfahan. The educational intervention was designed and carried out based on the educational needs of caregivers at all stages of taking care of people with dementia (PWD). In the initial and qualitative phases of this study, these factors were identified as the main needs of caregivers. Therefore, by analyzing qualitative data, the researchers extracted the educational needs of both knowledge and practice skills, adapted the educational content to the extended PLST model, and then used them during the intervention.
The intervention was provided by a team of psychiatrists, health education and health promotion experts, an elderly health research line, and a psychologist. The intervention group received the required education in 8 sessions of 2 hours and in groups of 13 and 12 persons. Educational sessions provided correct information to caregivers, focusing on knowledge from the nature and course of People with Dementia (PWD), the impact of the disease on the patient's religious and cultural capabilities, caregiving education according to the needs and daily activities of the patient, caregiving in connection with practice and psychological disorders of the patients, and caregiving according to high-risk and unsafe behaviors of the patients. In fact, with this intervention, caregivers obtain extensive education in the fields of caregiving management and planning, people with dementia (PWD), possible preventions, processes and courses of the disease, methods of increasing self-efficacy, and many other skills in the extended and systematic framework of PLST (Table 5).
To increase the knowledge of caregivers, the strategy of expressing successful and unsuccessful experiences of the caregivers (successive experiences) and mentioning different examples of different behaviors of patients and strategies used by caregivers to expose the CB of patients were useful. Since stigma or shame of occurrence of some unusual behaviors of patients is considered the most important barrier to caregiving, educating caregivers to improve communication skills, reduce negative emotions, correct mental errors, and replace positive thoughts were used to improve and upgrade the caregiving process. These sessions were conducted in the form of speeches, questions and answers, role plays, educational video clips, persuasions, and verbal encouragements. After the intervention, the caregivers received follow-up and telephone counseling for 1 month.
Data Collection Method in the Quantitative Phase
Data were collected using a questionnaire made by the researcher. This questionnaire was designed with the help of data from a qualitative study, some of the questions of the standard questionnaire (18), and another similar study (19).
The first part of the questionnaire included 12 questions about demographic characteristics. The second part of the tool was a questionnaire made by the researcher (containing 30 questions) to assess the caregivers' knowledge about the nature and course of the disease and how to take care of people with dementia (PWD), which was designed based on the qualitative study phase. The third part was concerned about measuring behavioral skills with the Likert method (never, seldom, sometimes, often, always from 4 to zero) in three caregiving fields of daily and physical needs of the patients, needs based on practice and mental disorders, and caregiving for risky and safety behaviors of the patient.
Determining the qualitative formal and qualitative validity of the questionnaire was done by a panel of 14 experts in health education, promotion of health, and psychiatry. The CVI and CVR of the questionnaire were 0.99 and 0.88, respectively. Additionally, for the reliability of instruments, a test-retest method with a time interval of 3 weeks was used with 29 caregivers. The reliability coefficients of the knowledge and behavior questions were 0.843 and 0.819, respectively. The reliability coefficient of behavior questions was separately evaluated in three different fields of caregiving: caregiving based on physical and daily needs of the patient (0.776), caregiving based on practice and psychological disorders of the patient (0.728), and caregiving based on risky and unsafe behaviors of the patient (0.759).
Data Analysis Method for Quantitative Phase
The collected data were coded into a computer and analyzed by SPSS statistical software version 18. In this regard, Pearson and Spearman correlation coefficients, independent t-tests, paired t-tests, and multiple regression models were used to determine the type and severity of the relationship between dependent variables and independent variables.