The chronic disease Self‐Management Programme: A phenomenological study for empowering vulnerable patients with chronic diseases included in the EFFICHRONIC project

Abstract Introduction The Chronic Disease Self‐Management Programme (CDSMP) has resulted in improved health outcomes for patients. However, research has focused mainly on those with chronic conditions and has not extensively explored prevention programmes targeting individuals with specific vulnerability profiles. Aim This study aimed to understand the effects of the CDSMP on the lived experience of vulnerable patients included in the EFFICHRONIC project in France, based on their needs and expectations before and after participation. Methods We conducted a qualitative phenomenological semio‐pragmatic study based on 37 in‐depth interviews with 20 patients (20 before/17 after CDSMP). Results By transforming existential dimensions (identity, relationship with others and bodily experience), chronic illness generates new needs in the vulnerable person. By resonating with the expectations and needs of participants, the CDSMP induces motivation and a sense of belonging to a community of peers. It has enabled the participants to become actors of their own health until empowerment. Although some limitations are reported, the programme has awakened a desire in the participants to take better care of their health and to develop personal skills with, for some, a desire to become involved in health education. Conclusion Our phenomenological approach highlighted the resonance between the programme (its design and implementation) and the lived experience of patients, as an effective element of empowerment. This necessitates training the facilitators to elicit the lived experience of patients. Furthermore, as a patient‐centred approach is required, the facilitators need to learn how to adapt the design of the programme to the singularity of the patient. Patient or Public Contribution Patients provided the data that were collected through in‐depth interviews, and their experiences before and after the programme were analysed.


| INTRODUCTION
The continuing increase in the number of people with chronic disease is one of the greatest challenges for healthcare systems worldwide.
Chronic condition multimorbidity is high, with prevalence increasing with age (up to 50% after 65 years). 1 The increasing proportion of older adults in the population, and of younger adults with chronic disease who will live to an advanced age, has huge consequences for policy and healthcare expenditures. 2 It has been estimated that chronic diseases may account for nearly 60% of overall mortality. 3 In most countries, the poorest people are at the highest risk of developing chronic disease. 4 The authors have added that vulnerable populations are of more concern because chronic diseases are responsible for 50% of the total disease burden in low-income countries. 4 Vulnerable populations refer to a wide range of groups, including the economically deprived, the ethnic minorities, the elderly or those who encounter barriers to accessing health care (geographical isolation, low access to public transportation, lack of social networks). 5,6 Several studies have reported almost an additional 10% of chronic disease in vulnerable populations. 7 They state that patients living in poverty are much more likely to be in poor health and to have disabling conditions, and are less likely to have used many different types of health care. Vulnerability may thus promote the incidence of chronic disease due to a higher frequency of risk factors in this population. Conversely, vulnerability can also be the consequence of chronic disease. 8 The work of Jeon et al. 9 demonstrated how socioeconomic and cultural differences produce short-and long-term inequalities in terms of self-care and health. This supports studies showing that chronic illness aggravates social vulnerability or precipitates people into precarity through loss of work. 10 A growing number of behavioural interventions to help people live with chronic diseases are emerging. 11 Among them, selfmanagement involves actions and behaviours necessary for the protection and promotion of health and for the management of the physical, emotional and social effects of the chronic disease. In a study of diabetic patients with vulnerability criteria (limited spoken English, uninsured and/or poor school education), a supervized, structured self-management programme demonstrated better outcomes than in usual care. 12 However, in the same population, a recent study 13 identified barriers limiting the implementation of selfmanagement (difficulty in accessing care/healthcare, interference with the social environment, lack of motivation). In addition, older people with low incomes consider health care and healthy ageing less essential than a population of the same age with higher incomes. 14 On the other hand, three factors would favour the benefit of selfmanagement in this population: peer support, a patient-centred approach and positive empowerment. Vulnerable people participated less often in self-management programmes and differed in support preferences (identifying community resources, improving communication and shared decision-making with healthcare providers). 15 Taken together, vulnerable people represent patients with the greatest need for education and support, but they are characterized by the highest task frequency and lowest self-efficacy, resulting in weaker adherence to self-management programmes. These findings may lead to a better tailoring of self-management approaches to address the specific requirements of the vulnerable population with chronic diseases. 16 Among the self-management techniques, the Chronic Disease Self-Management Programme (CDSMP) 17 was developed by a research group at Stanford University (US), and was built based on the qualitative work of Corbin and Strauss. 18,19 Since then, the CDSMP has been successfully implemented face to face around the world. [20][21][22] It includes the development of an action plan, and provides feedback with respect to problem-solving skills and other desired behaviours. It also serves as a guidance and training in attaining competencies such as the reinterpretation of symptoms and disease management. The conceptual elements underlying the methods of the CDSMP are self-efficacy, empowerment, peer-topeer education, recognition of the social determinants of health, community participation and risk stratification. 23 A few studies have recently been published and have highlighted a positive benefit of the CDSMP regarding ethnic minorities or low-wage workers. [24][25][26][27] Recently, the EFFICHRONIC project (http://effichronic.eu/) aimed to evaluate the CDSMP intervention in five European countries (France, Italy, Netherlands, United Kingdom and Spain) by specifically including adults with a chronic disease and vulnerable conditions (low income, social or geographic isolation) as well as their caregivers. 28 The revised Medical Research Council guidelines 29 have emphasized the need not only to measure outcomes but also to detail the process of implementing the intervention under study. Michie et al. 30 argued that qualitative or mixed methods can be used to understand health behaviours and thus identify effective components of a complex intervention such as the CDSMP. Although the CDSMP improves health, little is known about how participants experience the programme or the processes involved.
In this article, we conducted a qualitative study with vulnerable patients included in the CDSMP of the EFFICHRONIC project in France. The aim was to understand the effects of this programme by collecting information regarding the patients' lived experience, needs and expectations before and after their participation. This knowledge could help us to better understand what works in a complex intervention and to integrate it into educational strategies.

| EFFICHRONIC project intervention
The CDSMP consisted of a series of six workshops, 2.5 h each, which were held once a week for 6 weeks. The number of participants was no more than 15. An important conceptual element of the intervention concerned peer education. Participants with a chronic condition were encouraged towards self-management by professionals as well as peers (other participants with a chronic condition). One professional and one peer would volunteer together to lead a series of workshops. To this end, professionals and peers were recruited and trained on the CDSMP principles. Generally, each workshop had between seven and eight activities, with specific objectives to achieve. Each one integrated different techniques (individual work, small and large groups, brainstorming, etc.), had an agenda and time defined for each activity. Over the course of six workshops, participants were able to (i) set realistic health goals, (ii) learn to self-manage pain and discomfort, (iii) learn to self-manage their diet and (iv) learn to self-manage physical activity, mood and the way the disease influenced their personal relationships. The intervention is designed to actively involve participants. Through different activities, participants are supported to make different changes that increase confidence in their ability to manage the disease. The facilitators create the climate appropriate for changes to occur. For this, it was important not to judge people or their actions, to respect confidentiality in the workshops and to support fair participation.

| Design of the qualitative study
A qualitative semio-pragmatic phenomenological study was chosen to describe and understand the lived experience of vulnerable and chronically ill patients before and after their participation in the CDSMP intervention of the effichronic project. This report was guided by the COnsolidated criteria for REporting Qualitative research (COREQ). 31

| Participants and recruitment procedures: Purposive sampling
All inclusion and noninclusion criteria of the EFFICHRONIC project have been described elsewhere. 28 Briefly, conditions of vulnerability included older people (over 65 years) living alone or in retirement homes, or in a situation of social or family isolation; persons receiving a disability pension or allowance; low-income ethnic minorities; and low-income legal immigrants, refugees and/or asylum seekers. For asylum seekers, their residence had to have been known for at least 6 months. Low income was defined as below the poverty line at 60% of the median standard of living for the year 2015. 32 To evaluate precarity, we used Gijon's social-familial evaluation scale, which takes into account the person's familial and socioeconomic situation, housing, social relations and social support and assistance. The score is interpreted as follows: between 10 and 14: vulnerability in social support; 15 or greater: important lack of social support. 33 Our qualitative study was presented to the EFFICHRONIC leaders and facilitators orally, followed by an email that was then sent.
Participants in their groups were asked to partake in the study. The contact details of the volunteers were given to the investigator, who then contacted them by telephone to agree on a date and place for the first interview before their participation in the programme. They knew they would be contacted 6 months later to arrange the second interview after their participation in the CDSMP. The location of the interviews was left to the convenience of the participants. Fifteen of the first interviews were conducted at the participants' home (then 13 interviews at a 6-month interval). This had the advantage of placing the person in his/her living environment. Four interviews took place in rooms in the administrative centre of the City A University Hospital. One interview took place at the 'Secours Populaire' (a nonprofit French association engaged in providing food aid, clothing, access to and maintenance of housing, access to health care, socioprofessional integration, access to cultural activities and, more generally, access to rights for all) of City A. The interviews were carried out in urban, semi-rural and rural areas, and reflected a range of occupations and income levels of participants.
As qualitative research is an iterative process of sampling; required sample sizes cannot be calculated a priori. We used purposive sampling to obtain a diversity of patients' experiences.
The following criteria guided participant recruitment: age, sex, speaking French, educational level, vulnerability conditions and the experience of living with a chronic disease.

| Data collection: Semi-structured in-depth interviews before and after participating in the CDSMP
The interview guides (Supporting Information 1 and 2) were con-  | 949 methodology team checked the appropriateness, as well as the intelligibility, of the questions in two initial test sessions administered by the investigator. Follow-up prompts were designed to encourage participants to recount their personal experiences as authentically as possible. The investigator received preliminary training on phenomenological reformulation (prompts) to carry out the in-depth interviews. She reported her involvement after each interview.
After reading the briefing note, the investigator introduced herself as a junior general practice doctor (junior GP) working on her thesis. Before the interview began, the research objectives of the interview were explained to the participants. She made sure to create an atmosphere of confidence such that answers would be spontaneous and truthful. The respondents were informed that their responses would remain confidential and anonymized, meaning that their personal identification details would not appear. They were made aware of the possibility of being able to stop the interview at any time without any reason, and to withdraw from the study if they wished. The interviews were recorded. The sound quality was sufficient to produce audible and understandable voice files. The recordings were transcribed verbatim. We did not plan to collect nonverbal data. The interviews were anonymized by a coding from A to T (the letter A corresponds to the first participant interview and T to the twentieth) associated with number 1 for the interview conducted before the programme, and number 2 for the interview at 6 months.

| Analysis
Pragmatic phenomenology is a descriptive method of categorizing lived experiences recorded in interview transcripts. In this semiopragmatic method, 34,35 the analyst considers all the semiotic elements of a text, including linguistic and contextual clues. The approach of this semio-pragmatic analysis (Table 1) is based on several processes: on the semiotic characterisation of the selected themes, on a process of constant comparison 36 to construct empirical categories and on a principle of logical data ordering inspired by C. S.
Peirce's theories. 37 As a result of this ordering, the category that is the most conceptually dense (i.e., the highest level in the hierarchical classification of signs) controls the meaning of the phenomenon at stake.
The last step consists of restoring the meaning of the studied phenomenon in all its dimensions in the form of a general synthetic statement. Investigator triangulation was achieved by compiling the analyses of the two qualitative research experts and of the trained investigator. The interviews were stopped upon reaching data saturation, without the need to add more participants. See Table 2 for the participant characteristics.  Zone A is urban, B rural, C semi-rural. **psychological stages of serious illness according to E. Kübler-Ross.

| Research ethics and patient consent
***Gijón Scale : It takes into account the family situation, economic, housing, social relations, and socio-human support of the person. Between 5 and 9: the social situation is good or acceptable. Between 10 and 14 the person is socially at risk. Greater than or equal to 15 there is a social problem.
| 953 stuff, we're the ones who really know' said F2, who added 'we'll try to see each other outside, to continue our mutual aid'. The group enhances individual commitment: 'I did things that I never thought I would do, because there were commitments, but for the whole group it was like that' (E2). A2 continued to be involved: 'I put action plans in place that I still carry out today'. F2: 'it also helped me to tell myself to change my treatment, so I'm going to switch to immunosuppressants. My rheumatologist has been trying for 13 years'. O2 decided to get dentures, change his glasses and quit smoking. 1. Patients able to convey their experience during an interview and whose needs correspond to the elements of the programme design.

2.
A design that responds to the needs of the chronically ill patients: The CDSMP was designed to operate within a framework of support, to provide appropriate information, community support, a reinforcement of personal efficacy and to enable empowerment.
3. Facilitators, caregivers and peers, capable of eliciting the lived experience, expectations and needs of patients with chronic illness, and of implementing the programme in a way that is adapted as closely as possible to these needs, through a patient-centred approach.

| DISCUSSION
Our findings demonstrate that the vulnerable patient with a chronic disease (i) has a specific experience, (ii) encounters difficulties in understanding the whole process of care and (iii) finds it difficult to access the different health professionals and social assistance. All of these issues generate needs. Through our study, we have shown that certain characteristics of the CDSMP were able to meet the needs of the participants by transforming their lived experience. This in turn induced motivation along with a sense of belonging to a community of peers, and promoted empowerment.
We have shown the importance of identifying barriers and facilitators through participation in a self-management programme, particularly among the vulnerable population.
The first category showed that chronic illness transforms the Our study also highlighted the role of access to information and understanding of the healthcare system in chronic illness. This is consistent with Mackey's work, 47 showing that low literacy can lead to chronic illness. However, the study also showed that the adapted design is not enough. Favourable implementation conditions are needed. Among them, participants indicated that a person-centred approach by facilitators is essential for change. This reinforces the work of Michie et al., 30  The last category shows that the programme raises awareness of the importance of health education and awakens a desire to take better care of one's health and to commit to developing skills. This strong commitment leads to becoming an actor of one's own health.
Participants stated that 'sharing the experience of others leads to better self-management'. They emphasized the 'enormous support of the group' as the main determinant of empowerment, which is the goal of any educational process. These findings help us understand the mechanisms and processes that come into play using an approach Finally, our work has shown that some participants still need support and follow-up, while others show an enthusiasm to make a lasting commitment to collective health promotion. These are patients who have become aware that 'therapeutic education has changed their lives', that 'sharing experiences with peers is essential'. This means that, alongside scientific knowledge, there is 'experiential lay knowledge' that must be taken into account and that can be helpful to their peers. 54 This is what leads to autonomy and human dignity.
In a programme that is not focused on any one specific disease, it would be useful to offer a final interview to each person to identify their needs: those who need to consolidate some of their skills and direct those who could become patient-experts to appropriate training. Some have not been successful in maintaining their actions or in sustaining their goals, due to a lack of personalized support.
Various perspectives have been proposed to extend the effects of an intervention. Chen 55

| Strengths and limitations of the study
This study hypothesized an internal methodological consistency between the researched object (lived experience), the phenomenological approach to data collection and the semio-pragmatic data analysis, promoting a logic of emergence. One of the strengths of the study is that it has analysed, in the same population, the experiences and expectations of a health education programme before and about 6 months after participation. Semio-pragmatic analysis allows precision of the logical constructs of a studied phenomenon by using Peirce's Theory of signs, limiting investigator-related interpretation bias. Moreover, the participants were suffering from different diseases, and had a number of different demographic characteristics (age, sex, origin, family situation, different socioeconomic situations, living places). The methods used made it possible to highlight commonalities in the patients' experiences, despite these differences.
The qualitative phenomenological approach privileges a form of questioning that allowed us to access the richness of their lived experience of chronic illness in a way that is patient-centred. 58,59 Conversely, there was a male/female imbalance in our population that can be considered as a limitation, although this was representative of the population participating in the EFFICHRONIC programme (75% women). We should also acknowledge a potential selection bias in the programme, some people having already participated in therapeutic education workshops. This profile of patients may be more invested in their chronic illness, but we could suppose them also to be less receptive to a novel educative intervention. On the other hand, the majority of the participants included in our study were selected by the facilitators (bias towards social desirability).
However, the process of empowerment makes it possible to consider that if the participant had initially accepted to partake in the context of what he or she knew of the facilitator, the transformation of his or her lived experience could not be attributed to that facilitator.

| CONCLUSION
To the best of our knowledge, this is the first qualitative study to evaluate the CDSMP with pre-and postinterviews. Our phenomenological approach highlighted the resonance between the programme (its design and implementation) and the lived experience of patients, as an effective element of empowerment. This necessitated training the facilitators to elicit the lived experience of patients, and, as a patient-centred approach is required, facilitators had to learn to adapt the design of the programme to the singularity of the patient.
Despite some limitations, the programme has awakened a desire in the participants to take better care of their health and to develop personal skills, with some wanting to become more involved in community health education. Personalized follow-up actions complementing this type of intervention might provide an additional benefit for participants.

DATA AVAILABILITY STATEMENT
The data are available upon request, with agreement from the EFFICHRONIC consortium. The data will be provided to researchers having a protocol for analysis. For further information, contact the corresponding author.