Funding for this research was provided by:
Fundação para a Ciência e a Tecnologia (IF/00693/2015, BD/135496/2018)
Text and Data Mining valid from 2020-01-08
Received: 22 October 2019
Accepted: 22 November 2019
First Online: 8 January 2020
Ethics approval and consent to participate
: This study was approved by the Ethics Committee for Health of the São João University Hospital Center/Faculty of Medicine of the University of Porto (date: 27-07-2018; reference 208/18; scientific title “Internet-based support and training for informal caregivers of people living with dementia”; contact: ExternalRef removed). The Additional file InternalRef removed provides the participant information form and the consent form. The trial is set in Portugal and executed by the Institute of Biomedical Sciences Abel Salazar (University of Porto) and Center for Health Technology and Services Research (CINTESIS) with the support of the National Alzheimer’s Association (Associação Alzheimer Portugal). Confidentiality will be ensured before, during and after the study. An electronic informed consent will be used as alternative to the traditional signed paper consent. The study information and electronic informed consent are part of the online study platform. All study data will be collected via study online platform resorting to University of Porto digital questionnaires tools. This is a secure platform using encryption of communications (e.g., HTTPS) for participants’ protection. Socio-demographic data are collected in an anonymized manner. Besides the consent form, where the participants’ identification is mandatory, the only identifiable piece of information in the study concerns the email address, requested to the participants so they can receive all the related information. The use of the email address by the research team will be explicitly stated in the informed consent to be fully understood and accepted/rejected by the participant. Data, including the final trial dataset will be accessed by the research team only. There is no external data monitoring board. Acknowledging the new role of the Comissão Nacional de Protecção de Dados [national data protection commission], the research team will ensure the development of an internal document explaining all measures implemented for data protection purposes, to present in case of any auditing process. There is no plan to share IPD. No discomforts, inconveniences, and/or risks are expected for participants. As the intervention is performed online, participants are not required to make unusual travel arrangements. As sessions are accessed by participants at a time of their convenience, the study does not require the participant to be absent from work or any other usual activity or commitment, with no foreseen loss of income, for example. The devices used to access the intervention will be the participants’ usual devices; therefore there will be no place for the introduction of unusual and potential uncomfortable new devices. The study team will take appropriate action in case any adverse effects are reported by the participants. Important protocol amendments must be communicated to the Ethics Committee for Health of the São João University Hospital Center/Faculty of Medicine of the University of Porto, to the trial registry (ExternalRef removed) and to journals publishing trial related information.
: Not applicable.
: All authors declare that they have no competing interests or financial disclosures.