Perspectives on participation in dementia prevention clinical trials

Abstract: Dementia is an enormous global health challenge with a rapid increase in the number of people affected. There is an urgent need for research to find effective treatments and preventive strategies. Dementia prevention research is undergoing rapid development with novel approaches and techniques used. Both pharmacological and multimodal lifestyle randomized controlled trials (RCTs) have become longer, more complex, and target people earlier in the disease continuum. For the participants in clinical trials, this means new challenges. The overall aim of this thesis was to explore the experiences of participation in dementia prevention clinical trials among study participants, study partners, and specialized personnel/ staff. Furthermore, the aim was to further understand their attitudes and knowledge about dementia and related diagnoses. All studies used qualitative method. Data from different kind of RCTs was collected with questionnaires including open-ended questions, focus groups and individual interviews. Content analysis and Grounded theory were used. Study I Questionnaire with open-ended questions to 19 participants and 20 study partners in immunotherapy Alzheimer ́s disease (AD) phase I-II RCTs and group interview with eight staff members in the clinical trial unit were used. Staff members highlighted the high burden for the participants. The main motives for participation were a willingness to help research and the benefits of access to specialized care. The main disadvantages were that participating was time-consuming and perceived distress in connection to some investigations. Study II Focus group interviews were conducted within the Healthy Ageing Through Internet Counselling in the Elderly (HATICE) study with expert nurses (n=13) in cardiovascular disease (CVD) prevention in Finland and in the Netherlands. The purpose was to describe nurses' best experiences and practices with supporting CVD prevention and describe their suggestions on how to integrate their experiences into an online eHealth platform. Important aspects were to establish a relationship of trust, awareness and expectation management, and appropriate time and monitoring. Study III Focus groups interviews with older “at risk” adults (presence of CVD risk factors) in Finland, The Netherlands, and France were conducted as part of the HATICE study (n=44). The purpose was to explore attitudes of older adults at increased risk of CVD and dementia and engagement in an eHealth self-management prevention program as well as facilitators and barriers. The results were represented in three categories: access to reliable information about CVD and dementia, trust in the healthcare provider, and burden and stigma of dementia. Study IV Individual interviews with participants in multimodal dementia prevention MIND-ADMINI trial among persons with prodromal AD (n=8) were conducted. The participants' experience of participating in the trial is presented as a dynamic process. Previous knowledge, their motives, and the received information guide the participants' decision to take part in the trial. The trial was well tolerated and received even though the participants initially experienced high burden and difficulties managing information provided. Conclusions: Despite differences in the trials and target populations, the participants presented similar motives for participating in dementia prevention trials including altruistic, hope for personal benefits of the interventions, and access to specialized care. There are differences in the participants' preferences and need for support in a trial, between the participating countries, and along the disease continuum. To address this, a more person- centred approach in the conduction of the trials is suggested. This may improve participant ́s situation and the quality of RCTs which is important given the increasing complexity and new methods used in dementia prevention trials.