Designing a Digital Tool to Support Healthy Lifestyle in Men With Prostate Cancer
赞助:
Danish Cancer Society
合作者:
信息的提供 (责任方):
Dorthe Furstrand，Danish Cancer Society
| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 29, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | February 23, 2018 | ||
| 预计主要完成日期 | October 1, 2018 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Digital health service intervention design[ Time Frame: 5 months. Each iteration of workshops and interviews evaluated to inform the next. Data evaluation points each month. ] The primary outcome is a design product which supports men in their everyday life to have a healthy lifestyle through digital means. A process of 3 iterations of workshops and individual interviews produces data in the form of notes, sketches, pictures, recordings and prototype-products. By iterative analysis and confirmation and ideation in the following iteration, the primary outcome of this process is the design of a digital health service intervention to support men with prostate cancer in a healthy lifestyle. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Designing a Digital Tool to Support Healthy Lifestyle in Men With Prostate Cancer | ||
| 正式标题 ICMJE | Digitally Supporting Lifestyle Changes in Men With Prostate Cancer - Part 2: User-driven Design and Development of a Digital Tool to Support Healthy Lifestyle in Men With Prostate Cancer Based on an Ethnographic Study of the Target Group | ||
| 简要概况 | The emil project aims to design, develop, implement and evaluate a digital service to support a healthy lifestyle among men with prostate cancer. In this second study, men with a history of prostate cancer are invited to participate in the scoping and design of a digital platform, through three iterations of workshops and individual interviews, which includes prototyping and other ideation processes. Finally, the men with a history of prostate cancer will be involved in the usability testing of the design, to ensure a platform fit for use by the intended users. |
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| 详细说明 | In this user-driven study, the methods will be workshops, interviews, usability testing and a concluding proof of concept testing. Workshops constitutes the bigger part of the user-driven design and ideation in this project. In workshops a group of people will generate a synergy that opens up for new ideas in a framed setting. The workshop format uses methods such as affinity diagrams; innovation jams; and ideation guided through artefacts such as Lego or paper cuts, with the researcher as the facilitator. After analysing the outcome of each design iteration, the findings will be incorporated into the design and focus the planning of the succeeding workshops in an iterative process. The usability of the design will be tested in between workshops in interviews. The test will be performed by think aloud testing with the current prototype, recording for data collection and researchers in the room to observe, facilitate and probe for reflection. For a more elaborate usability testing to conclude the design phase, a proof of concept will be performed. In this living lab scenario, the tool will be used at home by end-users in the intended way. Issues with technical functionality, user interphase, data management and workflow will surface and can be corrected during the proof of concept, thus consolidating the service before the feasibility study. Data collection from this part of the study will be by ongoing dialogue with participants, by e-mail and telephone. To provide the broadest possible foundation for recruitment in terms of diversity in lifestyle and socioeconomic status, invitation to the study is done by mail directly to a randomly chosen group of men with prostate cancer. All iterations will be based on the results of the previous. The first iteration is based on the ethnographic input from the first study. All participants in study 2 will be met with a baseline questionnaire to evaluate digital readiness and e-health literacy and adjust participant configuration to ensure diversity. The questionnaire include self-reported educational level, health issues, treatments, diet, physical activity level and other lifestyle factors as well as eHLQ as part of the READHY questionnaire toolkit. The 13 dimensions of READHY comes from heiQ, HLQ and eHLQ, and work as a multidimensional validated robust psychometric instrument evaluation and can be used in combination to describe user's health technology readiness level and degree of enablement. Each activity of the user-driven design process will be documented in a report, that will serve as the data foundation for a scientific publication. | ||
| 研究类型 ICMJE | Observational | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Active, not recruiting | ||
| 预计入组 ICMJE |
55 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | October 1, 2018 | ||
| 预计主要完成日期 | October 1, 2018 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - All participants in the study will be men with prostate cancer, included in the Danish Cancer Registry under the IDC-10 code DC61 in the years 2014 or 2015. - All participant will have registered residence in eastern Denmark, either in the Capital Region or in Region Zealand. Exclusion Criteria: - Men with known non-localized prostate cancer at the time of diagnosis. Non-localised cancer will be defined by use of the TNM classification in the Danish Cancer Registry as proposed by Outzen et al [17]: Tis1-4,x and N1-3 and M0,1,x or Tis 1-4,x and N0,x and M1. - Participants will be excused from participation if they do not have sufficient written and spoken Danish language skills for participation in the activities involved in the studies. The researcher will assess whether the participants have sufficient cognitive functions to participate in the study, including be able to contribute to design workshops or report on everyday living. The researcher can also judge from an ethical perspective that the participant, for reasons not stated in the protocol, should be excused from participation in the study. | ||
| 性别 |
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| 年龄 | 最小年龄：50 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Denmark | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Dorthe Furstrand，Danish Cancer Society | ||
| 研究赞助商 ICMJE | Danish Cancer Society | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Danish Cancer Society | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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