Integrating programme theory into the development of a core outcome set for technology-assisted counselling interventions in dementia: study protocol of the ProCOS study

Background and rationale

The number of persons living with dementia worldwide is expected to rise to 152 million by the year 2050.1 At some point in the course of the disease, the decline of cognitive functions and behavioural and psychological changes2 result in an impaired ability to cope with everyday life and in an increasing need for family support. Due to the physical, mental and financial impact of dementia care,3 family caregivers may need professional support, but there are barriers to accessing and using formal care described in the literature.4

A common form of support for family caregivers is counselling services. Counselling can be defined as the ‘use of an interactive helping process focusing on the needs, problems, or feelings of the patient and significant others to enhance or support coping, problem solving, and interpersonal relationships’.5 Counselling provided by professionals such as nurses, social workers or psychologists is based on multidisciplinary knowledge, and a systematic approach is applied by using instruments such as assessments, guidelines or proposals for individual use.6 Counselling can thereby be differentiated from informal problem-solving or supportive conversations, which are intended to facilitate social interaction and mutual learning based on similar experiences.7

Information and communication technology (ICT) has been used to improve accessibility to counselling. Telephone helplines have been established decades ago8–10 and services that use videoconferencing software, email and/or chats to deliver counselling have increasingly appeared in recent years.11 12 Due to the SARS-CoV-2 pandemic, the use of ICT in delivering healthcare interventions was discussed more intensively.13 14 Technology-based counselling is considered a convenient way to provide services to persons who are homebound or to caregivers who do not have to arrange substitute care when counselling is provided remotely. In addition, persons living in rural areas with limited access to transport options may benefit from the use of ICT.6 15 Telephone helplines use a widespread and undemanding technology16 and can provide anonymous support.17 The lack of visual and non-verbal cues is a limitation of telephone counselling,18 which may be overcome with the utilisation of videoconferencing software.19 Synchronous videoconferencing facilitates a more direct interaction19 but poses challenges in terms of technological requirements and digital literacy.20 Asynchronously delivered counselling via email enables consumers to access services at any time but may prevent individuals from expressing themselves fully.21 22

The effectiveness of technology-based counselling in dementia has not yet been proven.23 We conducted a systematic review and included five randomised controlled trials. Meta-analyses revealed no significant effects of technology-based counselling interventions on depressive symptoms, burden and self-efficacy/mastery perceived by family caregivers of persons with dementia.23 Individual studies suggest some beneficial effects on outcomes, such as caregiver reaction to dementia-related behaviour and resource use.23 A wide range of outcomes (n=14) was examined in studies using different assessment instruments (n=21).23 In most cases, we found no theoretical basis guiding the development and evaluation of these complex interventions.23

The heterogeneity in outcomes examined in clinical studies and lack of theoretical foundation can be addressed in different ways:

The use of a core outcome set (COS) can reduce heterogeneity between trials and enhance comparability and thus, synthesis of evidence.24 A COS is ‘an agreed standardised collection of outcomes which should be measured and reported, as a minimum, in all trials for a specific clinical area’.24

COS for healthcare interventions in dementia, listed in the database of the Core Outcome Measures in Effectiveness Trials (COMET) initiative,25 predominately focus on outcomes of persons with dementia, as does the COS for the evaluation of non-pharmacological community-based health and social care interventions for people with dementia living at home.26 In addition, a set of measures has been recommended to evaluate psychosocial interventions for persons with dementia and their family caregivers.27

Non-pharmacological health and social care interventions include psychosocial and psychological interventions, educational and social programmes, case management and care coordination as well as assistive technology.26 Psychosocial interventions may address persons with dementia, family caregivers or both and are derived from diverse theories targeting a broad range of outcomes such as well-being, mood or behaviour.28 A COS that specifically focuses on technology-assisted counselling interventions for family dementia caregivers may contribute to assess the effectiveness of these interventions and to fill this gap in knowledge. In addition, outcomes associated with the use of ICT in delivering counselling may be identified in the developmental process. By drawing on existing COS, we assume that there will be overlapping domains but also areas, which may be complementary.

Theory-led approaches are essential to successfully develop, implement and evaluate complex interventions. This has been highlighted by the Framework for Developing and Evaluating Complex Interventions, which identifies programme theory as a core element of complex interventions.29 A programme theory is an ‘explicit theory of how an intervention is understood to contribute to its intended or observed outcomes’.30 The explication of assumed causal relationships and mechanisms of action allows for the quality of the theory to be critically reviewed, fosters a shared understanding among stakeholders and guides the implementation and evaluation of the intervention.29 30

In the ProCOS study, we build on previous work,31 which focused on the effectiveness23 and the implementation success6 of technology-based counselling interventions. To integrate findings of different modalities in delivering counselling, we differentiated the following types of interventions: counselling via telephone or email and counselling via videoconferencing; web-based psychosocial intervention: information, communication and counselling; videoconference or telephone-based counselling combined with tele-monitoring or psychoeducation and technology-based counselling as part of a comprehensive programme with non-technology-based components.6 By updating the former literature search,31 we expand the data basis to address the shortcomings of previous research described in the preceding sections. Therefore, we aim at bringing together the developmental processes of a COS and a programme theory for technology-assisted counselling interventions for family caregivers of persons with dementia.

There are two sets of questions guiding the research interest and informing the selection of methods within the ProCOS study:

1. What interventions that use ICT to provide counselling for family dementia caregivers are described in literature? What are the characteristics (frequency and duration, type of technology used, components of the interventions, stakeholders involved, adaptations to the context) of these interventions? What theoretical underpinnings for intervention development and implementation are explicated in the form of theoretical references, programme theories and/or logic models? What outcomes have been examined in clinical trials? What assessment instruments have been used?

2. How do family caregivers for persons with dementia and counsellors experience counselling services? What mutual expectations have persons seeking or providing counselling? Which outcomes should or could be achieved through counselling, and how can these outcomes be achieved? Which factors have an impact on the effectiveness of counselling? What are appropriate outcomes for assessing the effectiveness of counselling interventions?

Methods and analysis

Study design

To answer the aforementioned questions, a literature review and a qualitative substudy will be conducted. Results will be synthesised by developing a logic model, which comprises the elements of a ‘purposeful program theory’.30 Mechanisms of how changes can be achieved are described in the theory of change. The outcomes chain illustrates (possible) outcomes of the intervention, thereby constituting the ‘long list’ for the COS consensus process. The theory of action delineates what will be done within the programme or intervention to activate the theory of change and to achieve the outcomes.30 Based on the logic model, the preliminary programme theory of a technology-assisted counselling intervention in dementia will be formulated. A graphical presentation of the four working steps is displayed in figure 1.

Figure 1

Working steps within the ProCOS study.

The Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews,32 the Standards for Reporting Qualitative Research33 and the COS-STAndardised Protocol Items: the COS-STAP Statement34 were used to structure this protocol. Populated checklists are provided in the online supplemental file 1.

Supplemental material

Qualitative substudy

By this substudy, we aim to explore the lifeworld perception of relevant stakeholders on the importance of counselling in family caregiving from a phenomenological perspective.

Qualitative approach and research paradigm

Phenomenology is an approach ‘where the subject is understood as an embodied and socially and culturally embedded being-in-the-world’.41 A central concept of phenomenology is that of the lifeworld, which is understood as the world we take for granted in everyday life and that we do not question.41 Based on Schütz’s phenomenological sociology, we will focus on the essential structures of participants’ lifeworld.42

Context, researcher characteristics and reflexivity

The study will be conducted at an institute with a focus on dementia research. Assumptions and presuppositions resulting from the authors’ long-term engagement in this research field will be reflected and disclosed. The primary investigator has had experience in phenomenological research. This approach was chosen for the substudy because it allows the exploration of the lived experience of family dementia caregivers who have received counselling, and of persons who are providing counselling.

Units of study and sampling strategy

Interviews will be conducted with family dementia caregivers and persons who provide counselling in the field of family dementia care. To gain a deeper understanding of different approaches in the provision of counselling, we will include persons who have received or delivered counselling via technology, in person or both. Participants will be recruited by purposive sampling.43 A variance regarding the caregivers’ characteristics (age, gender, socioeconomic status, duration of caregiving and relationship to the care-receiving person) and those of the counsellors (professional qualifications and socialisation, duration of occupational experience, characteristics of employing organisations such as welfare organisations, municipal and private providers and healthcare insurances) is intended. Caregivers living with or near the person with dementia as well as long-distance caregivers will be included. Underaged persons (under 18 years old) and persons unable to consent for language reasons will not be included.

We will draw on existing contacts and networks to get access to the research field. We intend to recruit about 15 caregivers of persons with dementia and about 10 persons delivering counselling. The final sample size will be determined by saturation of information during the data collection process.44

Data collection methods and data processing

Semistructured interviews will be conducted.45 Open-ended questions will be asked in order to prompt narratives and to give the interviewees room to share their experiences.45 Questions will address experiences in receiving and providing counselling as well as stakeholders’ mutual expectations. Sociodemographic characteristics and information on the care arrangement and professional situation will be collected. Time and place of the interviews will be arranged at participants’ convenience. All interviews will be recorded and transcribed verbatim.

Data analysis

An interpretive phenomenological analysis will be performed applying a modified version of the seven-stage process described by Diekelmann.46 The analysis aims to identify themes representing shared practices and common meanings in participants’ lifeworld. Stages of analysis are displayed in figure 2.

Figure 2

Stages of the interpretive phenomenological analysis, modified after Diekelmann.46

Discussion

The ProCOS study focuses on technology-assisted counselling for family caregivers of persons with dementia—a support service likely to become increasingly important due to the rising number of persons with dementia and the growing support needs, the regional differences in the availability of support services and the advancing digitalisation.

Methodological approaches in the ProCOS study follow accepted guidelines.24 30 In trying to address the shortcomings of previous research, the methodological strands for developing a programme theory and a COS will be integrated. This innovation is a strength of this study, ensuring a theory-led approach to the development, implementation and evaluation of a technology-assisted counselling intervention for family caregivers of persons with dementia.56

Logic models have been used to synthesise data in systematic reviews,47–50 57 and as a visualisation of programme theory29 30, they represent a core element in developing and evaluating complex interventions.29 It has been debated whether logic models can represent the double complexity resulting from interacting components of complex interventions and adaptations of interventions to the context.58 Methodological approaches to develop more dynamic logic models have been proposed,52 and we will reflect on possible limitations in using logic models to capture double complexity.

Expected results include a systematic overview of the components of counselling interventions and their intended effects as well as the theoretical foundations. Apart from this, a compilation of outcomes (‘long list’) will be created, summarising outcomes already examined and outcomes suggested by the stakeholders interviewed. Furthermore, commonalities and differences in the stakeholder subjective perspectives and relevance structures will become visible.

The results of the ProCOS study will form the basis for a consensus process, which is to be conducted in a follow-up project. Using the Delphi methodology, relevant stakeholders will be involved in determining the important clinical outcomes and critically reviewing the preliminary programme theory. The instrument used in the consensus process is the logic model. Logic models are considered suitable for facilitating communication among stakeholders.47 The elements of the logic model will be gradually integrated into the consensus process of the COS so that the selection of appropriate outcomes is informed by stakeholder perspectives and theory—a requirement which has been formulated in the Framework for Developing and Evaluating Complex Interventions.29

The finalised programme theory will guide the development and implementation of a technology-assisted counselling intervention for family caregivers of persons with dementia. The consented COS will be used to assess the effectiveness of the intervention and may inform further research in the area of technology-assisted counselling in dementia.