Telemonitoring Among Patients With Multiple Myeloma

Not Applicable

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Device: e-coach multipel myeloma (MM)

• Registration Number: NCT05964270
• Lead Sponsor: Isala

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-26
• Last Update Submitted: 2023-07-26
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27
• Primary Completion: 2024-03-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group (IG)	e-coach multipel myeloma (MM)	participants of the intervention group (IG) will get a login for the e-coach MM, and access to eight modules: medication, outpatient visit preparation, periodic assessment, messaging service, alerts, information, ad hoc complaint, personal care plan. IG participants information is collected on a web platform that automatically invites enrolled patients. The e-coach MM is available 24/7.

Primary Outcome Measures

Name	Time	Method
blinded primary outcome by pill count	over a time periode of 3 months

Trial Locations

Locations (1)

Isala Klinieken; 🇳🇱 Zwolle, Overijssel, Netherlands