The Impact of Telemonitoring on Correct Drug Use, Complications and Quality of Life Among Patients With Multiple Myeloma (MM)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Myeloma
- Sponsor
- Isala
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- blinded primary outcome by pill count
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Job Eijsink
Principal Investigator
Isala
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
blinded primary outcome by pill count
Time Frame: over a time periode of 3 months