Telemonitoring Among Patients With Multiple Myeloma

Multiple Myeloma Clinical Trial

— ITUMM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964270
• Other study ID #: ITUMM
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: July 2023
• Source: Isala
• Contact: Job Eijsink, PharmD
• Phone: 0618885254
• Email: j.f.h.eijsink[@]isala.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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 .

Locations

Country	Name	City	State
Netherlands	Isala Klinieken	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Isala

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blinded primary outcome by pill count		over a time periode of 3 months