gms | German Medical Science

Background/research question: Programme theory is a core element of complex interventions. The theoretical understanding of the interventions as well as the stakeholders’ perspectives are important aspects in the selection of relevant clinical outcome measures [1]. Our systematic review did not reveal significant effects of technology-based counselling in dementia [2]. Five randomised controlled trials with 14 different outcomes were included. We found a lack of theoretical foundations in the development and evaluation of the interventions. To address these shortcomings, we aim at formulating an initial programme theory of a technology-assisted counselling intervention for family dementia caregivers and at generating the database for the consensus process of a Core Outcome Set.

Methods: In an innovative methodological approach, we will integrate the developmental processes of a programme theory and a Core Outcome Set. Data on the characteristics and theoretical foundations of counselling interventions as well as the outcomes examined in clinical studies will be collected in a scoping review. In addition, a phenomenological sub-study with semi-structured interviews will be conducted to explore the lifeworld perception of relevant stakeholders on the importance of counselling in family caregiving. The focus is on the experiences and the expectations of family caregivers and persons delivering counselling, as well as on the effects that can be achieved through counselling. Data from the literature review and the qualitative sub-study will be synthesised through the development of the logic model. Mechanisms of action and assumed causal relationships will be explicated in the elements of programme theory (theory of change, outcomes chain and theory of action), thus eliciting an initial programme theory.

Preliminary/expected results, outlook: We will provide a systematic overview of the components, theoretical foundations and intended effects of counselling interventions in dementia. In addition, a compilation of outcomes ('long list') will be created, summarising outcomes already examined in studies and outcomes suggested by the stakeholders interviewed. Furthermore, the stakeholders’ subjective perspectives will be incorporated into the initial programme theory of a technology-assisted counselling intervention for family caregivers of persons with dementia.

Funding statement: This study is funded by the Deutsche Forschungsgemeinschaft (German Research Foundation DFG, project number 533628714).

Competing interests: The authors declare that they have no conflict of interest.