NCT05964270

Telemonitoring Among Patients With Multiple Myeloma

The Impact of Telemonitoring on Correct Drug Use, Complications and Quality of Life Among Patients With Multiple Myeloma (MM)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Isala · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DEVICE	e-coach multipel myeloma (MM)	In this study we developed a multimodal patient-centered MM e-coach between September 2019 and June 2020. The content of the intervention consist of eight modules and was tested in a pilot study between June 2020 and August 2020 (F-ITUMM) 22. The e-coach is digitally managed, following three phases of the tiers of VBHC as presented in Figure 1. The tiers are classified in health status, process of recovery and sustainability of health 30. Furthermore, all medication information plus current dose and frequency per unit time are integrated in the e-coach. Reminders are sent if a session or a medication unit time is exceeded. Feasibility was tested for patients as well as healthcare professionals. The F-ITUMM trial concluded that the MM e-coach has the potential to support both recently diagnosed MM patients and healthcare professionals during MM treatment, and is a promising application to improve adherence .

Timeline

• Start date: 2021-03-01
• Primary completion: 2024-03-01
• Completion: 2024-07-01
• First posted: 2023-07-27
• Last updated: 2023-07-27

Locations

1 site across 1 country: Netherlands