The Impact of Telemonitoring on Correct Drug Use, Complications and Quality of Life Among Patients With Multiple Myeloma (MM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Isala
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- blinded primary outcome by pill count
研究概览
简要总结
A two-arm open-label parallel-group randomized controlled trial will be conducted to compare the telemonitoring (MM e-coach) with standard MM care. This study aimed to recruit 150 patients with recently diagnosed multiple myeloma (RDMM), starting first or second line of treatment. Blinded primary outcome is adherence by pill count after start of treatment at 1-3 months. Secondary outcomes are patient reported outcomes: Groninger frailty index (GFI), quality of life (EQ-5D-5L, EORTC-QLQ-C30), shared decision making (SDM-Q-9), self-reported adherence (MARS-5), single item questions, patient experiences (PREMs), adverse events, overall survival (OS) and progression free survival (PFS). Patient reported outcomes were developed and integrated in the e-coach MM to regularly measure digitized outcomes of MM patients from time of RDMM until 12 months post-diagnosis. Online measurements will be performed at baseline (0), 3, 6, 9 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Care Provider)
盲法说明
pill count
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, a participant (patient) must meet all of the -following criteria:
- •signed informed consent
- •>18 years
- •recently diagnosed MM patients with first-line or second-line treatment
- •able to complete patient-reported outcome measures and experiences
- •have minimal digital skills to check if they are able to interact with an e-coach
- •can read and understand Dutch.
- •Participants who meet any of the following criteria will be excluded from participation in this study
- •psychiatric illness requiring secondary-care intervention
- •too ill to engage with the intervention in the opinion of the clinical care team
- •no perspective of >12 months survival.
排除标准
- 未提供
结局指标
主要结局
blinded primary outcome by pill count
时间窗: over a time periode of 3 months
次要结局
未报告次要终点