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Background: Caregivers of people with dementia (PwD) face burden, feelings of loneliness, and social isolation. Previous studies have shown promising effects of online e-health interventions. Using social media may facilitate support for dementia caregiver networks. In an iterative step-wise approach, a social support tool entitled "Inlife" was developed. This paper describes the design of a study evaluating the effects of Inlife and its process characteristics., Methods: A mixed-method, randomised controlled trial with 122 caregivers of PwD will be conducted. Participants will be assigned to either the Inlife social support intervention or a waiting-list control group. After 16 weeks, the control group will obtain access to the Inlife environment. Data will be collected at baseline (T 0 ) and at 8-week (T 1 ), 16-week (T 2 ) and 42-week follow up (T 3 ). The 16-week follow-up assessment (T 2 ) is the primary endpoint to evaluate the results on the primary and secondary outcomes, measured by self-reported questionnaires. The primary outcomes include feelings of caregiver competence and perceived social support. The secondary outcomes include received support, feelings of loneliness, psychological complaints (e.g., anxiety, stress), and quality of life. A process evaluation, including semi-structured interviews, will be conducted to examine the internal and external validity of the intervention., Discussion: Using a mixed-method design, our study will provide valuable insights into the usability, effectiveness, and factors related to implementation of the Inlife intervention. Our study results will indicate whether Inlife could be a valuable social support resource in future routine dementia care., Trial Registration: Dutch trial register, NTR6131 . Registered on 20 October 2016.

Background: Recruiting and retaining participants in randomised controlled trials (RCTs) is challenging. Digital tools, such as social media, data mining, email or text-messaging, could improve recruitment or retention, but an overview of this research area is lacking. We aimed to systematically map the characteristics of digital recruitment and retention tools for RCTs, and the features of the comparative studies that have evaluated the effectiveness of these tools during the past 10 years.Methods: We searched Medline, Embase, other databases, the Internet, and relevant web sites in July 2018 to identify comparative studies of digital tools for recruiting and/or retaining participants in health RCTs. Two reviewers independently screened references against protocol-specified eligibility criteria. Included studies were coded by one reviewer with 20% checked by a second reviewer, using pre-defined keywords to describe characteristics of the studies, populations and digital tools evaluated.Results: We identified 9163 potentially relevant references, of which 104 articles reporting 105 comparative studies were included in the systematic map. The number of published studies on digital tools has doubled in the past decade, but most studies evaluated digital tools for recruitment rather than retention. The key health areas investigated were health promotion, cancers, circulatory system diseases and mental health. Few studies focussed on minority or under-served populations, and most studies were observational. The most frequently-studied digital tools were social media, Internet sites, email and tv/radio for recruitment; and email and text-messaging for retention. One quarter of the studies measured efficiency (cost per recruited or retained participant) but few studies have evaluated people's attitudes towards the use of digital tools.Conclusions: This systematic map highlights a number of evidence gaps and may help stakeholders to identify and prioritise further research needs. In particular, there is a need for rigorous research on the efficiency of the digital tools and their impact on RCT participants and investigators, perhaps as studies-within-a-trial (SWAT) research. There is also a need for research into how digital tools may improve participant retention in RCTs which is currently underrepresented relative to recruitment research.Registration: Not registered; based on a pre-specified protocol, peer-reviewed by the project's Advisory Board. [ABSTRACT FROM AUTHOR]

Background: HIV testing for marginalized populations is critical to controlling the HIV epidemic. However, the HIV testing rate among men who have sex with men (MSM) in China remains low. Crowdsourcing, the process of shifting individual tasks to a group, has been increasingly adopted in public health programs and may be a useful tool for spurring innovation in HIV testing campaigns. We designed a multi-site study to develop a crowdsourced HIV test promotion campaign and evaluate its effectiveness against conventional campaigns among MSM in China.Methods: This study will use an adaptation of the stepped wedge, randomized controlled trial design. A total of eight major metropolitan cities in China will be randomized to sequentially initiate interventions at 3-month intervals. The intervention uses crowdsourcing at multiple steps to sustain crowd contribution. Approximately 1280 MSM, who are 16 years of age or over, live in the intervention city, have not been tested for HIV in the past 3 months, and are not living with HIV, will be recruited. Recruitment will take place through banner advertisements on a large gay dating app along with other social media platforms. Participants will complete one follow-up survey every 3 months for 12 months to evaluate their HIV testing uptake in the past 3 months and secondary outcomes including syphilis testing, sex without condoms, community engagement, testing stigma, and other related outcomes.Discussion: MSM HIV testing rates remain poor in China. Innovative methods to promote HIV testing are urgently needed. With a large-scale, stepped wedge, randomized controlled trial our study can improve understanding of crowdsourcing's long-term effectiveness in public health campaigns, expand HIV testing coverage among a key population, and inform intervention design in related public health fields.Trial Registration: ClinicalTrials.gov, NCT02796963 . Registered on 23 May 2016. [ABSTRACT FROM AUTHOR]

Background: To test seven different strategies for recruitment in a randomized controlled trial, to report documented response data from each strategy, and to discuss recruitment challenges.Methods: We used 5 opt-in (potential participants have to do something active to contact or be contacted by the researcher) and 2 opt-out (potential participants have the option to decline being contacted about a study) recruitment strategies from February 2013 until July 2014 to contact 1562 cancer patient candidates for participation in a randomized controlled trial. For each of these cancer patients a caregiver was also invited to take part in the study.Results: Of the 1562 candidates, 22.6 % were ineligible on initial contact, 56.7 % declined to participate on initial contact, and 8.9 % agreed orally to participate but did not complete the enrollment. The 2 opt-out strategies, on-site recruitment and routine care letters recruitment, yielded the highest number of recruited participants with 79 dyads and 58 dyads respectively, constituting 42.7 % and 31.4 % of the total number of enrolled candidates. The 5 opt-in recruitment approaches yielded 49 dyads for the study. Almost half of these dyads were recruited using the approach termed "relying on providers at the hospital."Conclusions: In this study, opt-out recruitment strategies appeared to be the most effective.Trial Registration: Registration number NCT01867723 , registered February 2012. [ABSTRACT FROM AUTHOR]

Digital tools for trial recruitment and retention - plenty of tools but rigorous evaluation is in short supply Geoff Frampton and colleagues asked 'What are the types and characteristics of the digital tools that have been evaluated for improving the recruitment and/or retention of people in randomised trials? The second study by Amanda Blatch-Jones and colleagues [[2]] asked staff at UK Clinical Trial Units what digital recruitment and retention tools they use and asked staff at the National Institute for Health Research (a UK trial funder) about the digital tools their funded trials use. [Extracted from the article]

Background: Many randomized controlled trials have investigated the effects of exercise on the rehabilitation of patients with breast cancer. However, the exercise forms used in most previous studies were monotonous. Therefore, we designed a protocol to estimate the effects of combined exercise intervention using Internet and social media software on the rehabilitation of postoperative patients with BC.Methods/design: This study protocol is a randomized control trial with an intervention time of 12 weeks. After completing baseline questionnaire and physical fitness tests, the participants are randomized to the study group or the control group. Procedure contents of exercise intervention in the study group include: via phone step-recording app, ask the individuals to complete the target number of steps within a specified period of exercise, four times per week; face-to-face remote video guidance of individuals on muscle training, three times per week; common knowledge of physical exercise BC rehabilitation will be pushed regularly by social media apps every day. The control group will receive normal treatment and rehabilitation according to daily specifications of the hospital. The primary outcome will be the quality of life. The secondary outcomes are physical fitness and social cognitive indicators.Discussion: This study is a clinical trial to estimate the effects of combined exercise intervention based on the Internet and social media software for postoperative patients with breast cancer (BC). If expected results are achieved in this study, measures and methods of BC rehabilitation will be enriched.Trial Registration: Chinese Clinical Trial Register, ChiCTR-IPR-17012368 . Registered on 14 August 2017. [ABSTRACT FROM AUTHOR]