Worldwide, over 50 million people were living with dementia in 2020, with over 10 million new cases each year [1]. Due to population ageing, the number of affected persons is expected to almost double every 20 years, reaching 82 million in 2030 and 152 million in 2050 [2]. In Switzerland, where the population is among the oldest on the planet, 146,500 people were living with dementia in 2020, with one new person diagnosed every 17 minutes [3]. For each person with dementia (PwD), between one and three relatives are involved in providing assistance, supervision and care, which increase in intensity over the course of the disease [3]. These informal caregivers of a person with dementia (ICD), often the spouse or adult children, spend on average 5.7 hours a day in caregiving; female ICD contribute 70% of these hours [4]. ICD voluntary involvement is key to the sustainability of most health care systems as it covers about 40% of the costs of dementia worldwide [4], and 47% in Switzerland [5].
The sustainability of the contribution of ICDs is a core public health issue, as taking up such a role is becoming more difficult due to shifting family structures (e.g. smaller family size, family members living further apart, blended family), as well as higher employment rates for women and increasing professional pressure on all workers [6]. Although informal caregiving is often considered rewarding as it provides a sense of personal accomplishment and strengthens relationships [7], it also imposes high demands and costs, particularly for those involved in dementia care. Many ICDs experience long periods of chronic stress and a heavy subjective burden, reduced quality of life and social isolation, as well as increased physical and mental health challenges, compared to their non-caregiving counterparts or to caregivers of people without dementia [e.g. 8, 9]. ICD subjective burden and health deterioration are core predictors of early institutionalisation [10] and mistreatment [11] of their care recipient. In Switzerland as in many other high-income countries, a diversity of support options are available for PwD and their ICDs. Most of the support focuses on diagnosis, treatment and care for the PwD, as well as respite and information for the ICD [12, for more details see 13]. Training opportunities supporting ICD self-management are less common, despite their relevance to prevent the exhaustion of ICDs and protect their quality of life [14].
Identifying and adapting a psycho-educative group intervention for ICDs in Switzerland
The Medical Research Council (MRC) framework describes four phases for the development of complex interventions [15]: 1) develop or identify intervention, 2) feasibility, 3) evaluation and 4) implementation. In order to develop a psycho-educative intervention for ICD we conducted several steps belonging to the first three phases of the MRC framework (for an overview, see Fig. 1).
Development phase. We conducted a scoping literature review to identify effective interventions for improving the quality of life of ICDs (step 1), which showed that focusing on coping strategies with a psycho-educative group intervention holds the most promise for countering chronic stress in ICDs [e.g. 16]. Indeed, a recent meta-analysis of 56 multifactorial studies confirmed that coping strategies and self-efficacy were core and highly stable predictors of subjective caregiver burden [17]. Two other meta-analyses showed that psycho-educative interventions have the broadest effects, compared to other forms of support [18, 19]. Coping with the daily stress of dementia caregiving is the main focus of the psycho-educative group programme “Learning to feel better… to help better” (LFBHB) developed in Quebec, Canada, which is currently the sole intervention in French supported by empirical evidence [20]. This programme of 15 weekly sessions of two hours each focuses on five main themes: 1) Daily life organisation and communication with a PwD; 2) The appraisal of stressful situations, identification of what is modifiable versus non-modifiable and choice of relevant coping strategies; 3) Problem solving in modifiable situations, in particular for problem behaviours of the person with dementia; 4) Reframing in non-modifiable situations, in particular for thoughts and emotions related to mourning; 5) Finding and asking for support (for more detail see the methods section). The LFBHB programme was first tested in a randomized controlled trial across six centres in Quebec with 116 ICDs; It was found effective in decreasing the frequency of behaviour problems in the PwD and associated distress in the ICD, with respective effect sizes of d=0.09 and d=0.38 [20].
Feasibility and evaluation phases. In a previous study, we evaluated the feasibility of this programme in a different cultural context, French-speaking Switzerland, with a one-group pre-post design involving 18 ICDs across two regions [13] (step 2). The programme was well accepted, with high participation rates (on average, ICDs took part to 92% of the sessions) and low dropout rates (21%). Participants showed substantial and significant improvements in burden (d=0.41), psychological distress (d=0.54) and self-efficacy (d=0.43). However, recruitment was a challenge due to the length of the programme [13]. Consequently, we performed a qualitative evaluation to identify barriers and facilitators of the recruitment process [21] (step 3). Based on these findings, the programme was then adapted, with a participatory approach, to facilitate recruitment (step 4). Following the adaption, we conducted a second feasibility and pilot trial (step 5) to evaluate if this new intervention showed improved feasibility while maintaining similar effects as observed in the first feasibility study. The current article describes the approaches and results for steps three, four and five (see Fig. 1).
Aims of the Study
The aim of step 3 was to identify the facilitators and barriers to participation in the LFBHB programme using semi-structured interviews with professionals or volunteers involved in the recruitment of participants. The aim of step 4 was to adapt the programme to the Swiss context based on the identified facilitators and barriers, using a participative approach involving experts as well as ICDs with experience in the programme. Step 5 was a feasibility study: Within a pilot trial with a single group pre- and post-test design, conducted in two regions of the French-speaking part of Switzerland, we evaluated whether the new LFBHB-Switzerland programme showed improved feasibility and similar effects compared to the original LFBHB evaluated in our previous trial. Regarding improved feasibility, we expected 1) an efficient recruitment process (easy recruitment of 7 to 10 participants per group, few refusals linked to the length of the programme), 2) high participation and low drop-out rates during the programme, and 3) improved acceptability of the diverse components of the programme. Regarding the changes in outcomes associated with participation in the programme, we expected improvements on the five core outcomes comparable in size to those observed in our first trial. These five outcomes are the frequency of behaviour problems in the PwD, the reactions of the ICD to these problems, as well as the ICD’s subjective burden, self-efficacy, and psychological distress. In parallel, we aimed to obtain in-depth qualitative information about the new features of the programme, as well as its benefits and challenges, from the point of view of ICDs.
Step 3: Qualitative study of facilitators and barriers to participation
Methods. At the end of our first pilot trial testing the feasibility of the original LFBHB programme, we conducted a qualitative study of facilitators and barriers to participation [21, 22]. We conducted semi-structured interviews with 15 professionals or volunteers employed in 10 different institutions actively involved in the recruitment of LFBHB participants, such as memory clinics, homecare agencies, day-care centres, the Alzheimer Association and the Red Cross. The questions focused on facilitators and barriers to participation in the context of the recruiter’s institution, of their relationship with ICDs and of ICD’s reactions to the information provided about the intervention. Interviews lasted on average 40 minutes (min = 21, max = 62). All interviews were audio recorded, verbatim transcribed and verified. We conducted a content analysis following the procedure described by Mayring [23] with inductive category development.
Results. We identified three categories [for details, see 21, 22]: 1) compatibility with everyday life and resources, 2) finding the right moment for participation and 3) familiarity of the recruiter as a facilitator for participants’ involvement. Regarding 1) compatibility with everyday life and resources, a major obstacle to participation was the duration of the programme. Many ICDs were reluctant to commit for 15 weeks as they were living from day to day due to a highly unpredictable and demanding context. A second barrier was transportation to the course location, which was often difficult for older participants. A third hindrance was the term “training” used in the course flyers, which was often associated with effort and high demands. Regarding 2) finding the right moment for participation, many recruiters first came in contact with the ICD when the latter was already stressed and exhausted. At such a time, respite was a priority. Taking part in a psycho-educative programme, which requires resources to develop new competencies, was seen as additional stress. Regarding 3) familiarity of the recruiter as a facilitator for participants’ involvement, recruiters with a good knowledge of and a trusting relationship with ICDs found it easier to identify those who could benefit from the programme and provide them with adapted information, while the ICDs listened to them with confidence. Recruiters with a good knowledge of the programme were able to provide detailed and relevant information, while those with less knowledge often presented LFBHB as one support option among others.
Step 4: Adaptation of the programme to the Swiss context using a participatory approach
Methods. Seven experts in the field of dementia caregiving composed our multidisciplinary advisory team (psychology, nursing, social work, occupational therapy). These experts were active in diverse environments (applied research, education in nursing, memory clinic, day-care centres, Alzheimer Association) in two cantons of Switzerland (Fribourg and Jura). All experts were familiar with the LFBHB programme. Based on the results of the qualitative study, this advisory team elaborated concrete propositions for improving recruitment and for shortening the programme. The propositions on recruitment were then submitted to 4 other professionals from local memory clinics (1 geriatrician, 1 neuropsychologist) and homecare agencies (2 nurses). We also presented the propositions for programme shortening to 1) 5 ICDs (5 women: 4 spouses and 1 sister) with experience in the LFBHB programme, within a focus group, and 2) 4 other experienced LFBHB course leaders from 3 regions of Switzerland and from Québec (Canada), within semi-structured individual interviews. All the discussions were audio recorded and the expressed opinions were summarized.
Results. All experts and ICDs were in favour of keeping the five main themes of the programme. All of them further agreed that the didactic methods should globally be maintained, namely providing information about one theme with its practical tools, then applying these tools to the stressful situations of the course participants, and in addition encouraging the latter to use these tools at home between course sessions (homework). All participants further agreed on the importance of asking experienced caregivers who had already completed the course to share their knowledge with course participants. As regularly telling their live stories during the course would put an additional burden on the experienced caregivers, all experts and all ICDs considered the use of filmed stories an excellent alternative. We identified a consensus for shortening the programme and improving recruitment by three means:
- Before the start of the programme, raising the ICDs’ awareness about stress and coping by showing them a 30-min introduction video film about stress and coping in the context of dementia caregiving. This video presents in detail the course content, including stories of former participants.
- During the programme, a) condensing and standardising information delivery by using short didactic video films (5 videos of 8 to 15 min, one per theme) including stories of how former participants applied the programme strategies in their daily life, to facilitate transfer, and b) limiting the number of exercises for all themes (1-2 instead of 2-3) as well as conducting some exercises in subgroups so that more participants can be active. These changes helped reduce the number of sessions to 7 (instead of 15) with a slightly longer session duration of 3 hours (instead of 2 hours), for a total of 21 hours (instead of 30).
- After the programme, offering additional opportunities to exercise during booster sessions, so that all participants have a sufficient opportunity to practice the programme strategies despite the reduced duration and get continuing support after the end of the intervention.
Step 5: Feasibility study
Methods
In reporting on this quasi-experimental intervention study we follow the Template for Intervention Description and Replication Checklist (TIDieR) guidelines [24]. The data presented here were collected between 2017 and 2020.
Sample
We recruited a convenience sample of 47 ICDs through service providers in the field of dementia (Alzheimer Association, home care nurses, memory clinics, day-care centres) operating in two regions of the French-speaking part of Switzerland (Fribourg and Jura). Participants volunteered for a psycho-educative intervention focusing on stress management, along with pre- and post-intervention interviews. Inclusion criteria were 1) being a regular informal caregiver (at least once a week on average) of a person living with a diagnosis of dementia (as reported by the ICD based on a physician evaluation), 2) caring for this person since at least 6 months. Exclusion criteria were 1) insufficient French-language skills, 2) low caregiver burden (score below 10 on the Zarit Burden Interview), and 3) no memory or behavioural problems in the PwD. Participating ICDs were mostly women (83%, N = 39), and often spouses (51%, N = 24) or children (45%, N = 21) of the PwD, with a median age of 61 years (Q1 = 56, Q3 = 69, range 38–83). PwD were more often men (57%, N = 27) with a median age of 78 years (Q1 = 72, Q3 = 84, range 55–93). All had a diagnosis of dementia, including 51% (N = 24) Alzheimer’s disease, 34% (N = 16) unspecified or mixed dementia, 9% (N = 4) vascular dementia, 4% (N = 2) fronto-temporal dementia, and 2% (N = 1) Lewy body dementia. The ICDs had been providing care for a median duration of 2 years (Q1 = 2, Q3 = 4, range 0.75–10 years), and were currently in charge of the patient for a median of 5 days per week (Q1 = 1.5, Q3 = 7, range 0.5–7 days). Participants were requested to pay a course fee of 210 Swiss Francs (230 US$), which could be waived upon request (this occurred for two ICDs).
Procedure
The study was performed in accordance with the Helsinki Declaration and was approved by the local ethics review board (ISRCTN13512408). Written informed consent was obtained from each ICD following oral and written information provided by a member of the research team. Fig. 2 offers an overview of the study procedure.
Before the intervention, during an individual interview with an experienced researcher, participants completed five questionnaires. During the interview, we asked whether participants needed someone else to care for their PwD during the intervention, which we could organise with the local Alzheimer Association, our partner in the project. The ICDs then participated in the intervention described below. After the end of the intervention, they took part in a second interview with the same researcher to complete the five questionnaires again, and report on their experience with the intervention by answering open and closed questions.
Intervention
The LFBHB intervention was originally developed by Louise Levesque, Francine Ducharme and their team in the years 2000s, based on Lazarus and Folkman’s transactional theory of stress and coping [25]. The programme aimed at improving the ability of ICDs to cope with the stressful demands of caring for a person with dementia living at home [26]. Its content focuses primarily on 1) the appraisal of stressful situations, and 2) the coping strategies, organised around the five themes presented earlier. Regarding appraisal, participants learn to break down a global situation into specific ones, identify precisely what is stressful, and distinguish between situations or aspects which can be modified and those which cannot. Regarding coping strategies, participants are trained to choose an appropriate strategy depending on whether the situation can be modified or not, to use problem solving techniques for modifiable situations (seven-step procedure), to use reframing for unmodifiable situations (looking at things from another angle to reduce painful emotions), and to seek social support (identify precise support needs and the best persons to address each of them, learn through role playing how to ask efficiently for the needed support). In addition, information is provided on how dementia may affect the communication and relational behaviour of the affected person, and how ICDs may improve their communication skills and prevent tensions, including role-playing exercises about communication. The programme uses a combination of 1) information provision, 2) group discussions, 3) work on personal stressful situations, and 4) exercises at home. The content and methods used in programme are described in detail in Lévesque et al. [26]. Participants receive a booklet containing key information and exercise sheets, and the course leaders deliver the intervention according to a detailed manual. A logbook was given to participants to collect notes about difficult and enriching situations in their daily caregiving during two weeks before the start of the intervention. The shortened intervention consisted of 7 weekly group sessions of 3 hours each (with a 20-minute break in the middle). It was held in a quiet room with easy road and public transportation access, located at the School of Health in Fribourg or at a local day-care centre in Jura between 2017 and 2020. Two nurses and three psychologists with expertise in dementia and work experience with informal caregivers delivered the sessions in pairs for large groups (7-10 participants) or alone for smaller groups. All course leaders had completed a 4-day training related to the intervention programme, had experience in leading the courses and had received supervision from a trained psychotherapist with extensive experience in psycho-educative group interventions. Adherence to the course manual was not assessed as it had already been confirmed in a previous phase [13].
Measures
We collected 1) quantitative measures for five outcomes, using four questionnaires (one is assessing two outcomes), and 2) quantitative and qualitative post-intervention reports on the experience about the programme.
Questionnaire measures
Caregiver’s subjective burden. We measured the burden using the Zarit Burden Interview [27], a validated and widely used 22-item questionnaire. Responses are provided on a scale from 0 (never) to 4 (very often). Scores above 18 indicate a heavy burden and scores above 32 a severe burden [28].
Memory and behavioural problems (MBP) and caregiver’s MBP-related distress. We measured these two outcomes with the Revised MBP Checklist [29], a questionnaire which measures the frequency of 24 MBP in the previous week from 0 (never) to 4 (daily), and the extent to which this disturbed or upset the ICD between 0 (not at all) and 4 (extremely). This questionnaire is in French and has satisfactory psychometric properties: the factor structure is confirmed, internal consistency is good and the convergent validity is well established [29].
Caregiver’s psychological distress. We used the short version of the Ilfeld Psychiatric Symptoms Index [30], a questionnaire asking participants to rate 14 symptoms related to depression, anxiety, anger and cognitive disturbance, on a 4-point scale from 1 (never) to 4 (very often). The psychometric properties are satisfactory for the English [30] and French [31] versions.
Caregiver’s self-efficacy. We measured self-efficacy as initially suggested by Bandura [32], with a visual analogue scale ranging from 0 (no confidence at all in my ability to assume my caregiver role) to 10 (full confidence).
Post-intervention reporting on the experience of the programme
Quantitative. We assessed the perceived usefulness of the four strategies (communication, modifying unhelpful thoughts, problem solving and support seeking) and seven methods (short video films, information provided by the course leaders, course booklet, working on personal situations, large group exchanges, small group exchanges and exercises at home) used in the programme. For each, there were three items: 1) I found it interesting, 2) I found it useful, and 3) It helped me in my daily life. Answers were to be given on a 5-point scale: 0 Not at all or very little, 1 A little, 2 Moderately, 3 Very, 4 Extremely. As they correlated highly with each other (in nearly all cases Spearman’s ρ > .50) we created a new variable which was the average of the three items for each strategy or method. Regarding the four strategies, we also asked the two following questions: 1) I found it difficult to understand, 2) I found it difficult to apply; With answers on the same 5-point scale.
Qualitative. Semi-structured interviews were performed with participants two weeks after the end of the programme, at the location where the course was given or in their homes. The interview guide focused on benefits and negative aspects of the intervention as well as participants’ experience regarding the course, including adapted or new elements such as the course material (e.g. films) and the organisation of the course. Interviews were audio recorded, verbatim transcribed and anonymized.
Data analysis
Quantitative. We used descriptive statistics to provide general information on the study outcomes (mean and standard deviation, SD, to allow comparability with the original study, as well as the median, Q1 and Q3, as the variables showed some deviation from normality) and to analyse the quantitative post-intervention reports (median, Q1, Q3 and boxplots). For the five quantitative outcomes, changes between pre- and post-intervention were tested with a MANOVA for repeated measures, with time (pre versus post) and measure (the five scales yielded by the questionnaires) as independent variables, and the questionnaire score as the dependent variable. If this analysis yielded a significant result for the time effect, we computed for each outcome a post hoc paired t-test (one-tailed), and the effect size (Cohen’s d). We also tested differences between the original programme [15 sessions, 13] and the shortened one regarding changes between pre- and post-intervention for the five outcomes with a programme (original versus short) x time MANOVA for each of the five outcome. Differences between the original and short programme were also tested for the quantitative post-intervention reports with a Mann-Whitney U test.
Qualitative. The coding system developed during the first pilot study was used to code the qualitative interviews [13]. This coding system was developed by following the Mayring [23] approach for summarizing content analyses with inductive category assignment. The interviews in the current study were analysed and reviewed to evaluate if all quotes could be assigned to a code and category of the coding system developed earlier or if new codes or categories needed to be added. Additional categories and codes were created with the Mayring [22] inductive summarizing approach to assign in-depth information about the adapted and new elements of the course (the different steps of the approach are described in [13]). Regular meetings within the research group were held to discuss findings and discrepancies, in particular during interview coding with the pilot study coding system. Atlas.ti version 9 analytical software was used to facilitate the analysis process.