Telemonitoring Among Patients With Multiple Myeloma
ITUMM
The Impact of Telemonitoring on Correct Drug Use, Complications and Quality of Life Among Patients With Multiple Myeloma (MM)
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-myeloma
Started Mar 2021
Typical duration for not_applicable multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
July 18, 2023
CompletedFirst Posted
Study publicly available on registry
July 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedJuly 27, 2023
July 1, 2023
3 years
July 18, 2023
July 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blinded primary outcome by pill count
over a time periode of 3 months
Study Arms (2)
Intervention group (IG)
ACTIVE COMPARATORparticipants 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.
Control group (CG)
NO INTERVENTIONParticipants in the CG (control group) will only get a login for a 'dummy version' without the modules, besides the periodic assessments (questionnaires), at the same time as the IG
Interventions
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 .
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Isalalead
Study Sites (1)
Isala Klinieken
Zwolle, Overijssel, 8012AB, Netherlands
Related Publications (1)
Eijsink JFH, Geerts PAF, Kamminga K, Edens MA, Boersma C, Postma MJ, Maring JG, Ter Horst PGJ. The impact of telemonitoring on correct drug use, complications and quality of life among patients with multiple myeloma (ITUMM): A study protocol for an open-label, parallel-group, randomized controlled trial. PLoS One. 2024 Aug 26;19(8):e0307177. doi: 10.1371/journal.pone.0307177. eCollection 2024.
PMID: 39186588DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Job Eijsink, PharmD
Isala klinieken department clinical pharmacy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Masking Details
- pill count
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 18, 2023
First Posted
July 27, 2023
Study Start
March 1, 2021
Primary Completion
March 1, 2024
Study Completion
July 1, 2024
Last Updated
July 27, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF