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The Impact of Telemonitoring on correct drug Use, complications and quality of life among patients with Multiple Myeloma (MM);(ITUMM)

The Impact of Telemonitoring on correct drug Use, complications and quality of life among patients with Multiple Myeloma (MM);(ITUMM) - Telemonitoring among patients with multiple myeloma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49218
Enrollment
150
Registered
2021-08-10
Start date
2021-04-12
Completion date
Unknown
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

haematological cancer multiple myeloma

Interventions

None listed

Sponsors

Isala Klinieken
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, with informed consent, a subject (patient) must meet all of the following criteria: Patients meeting any of the following criteria may be included in the study: • Females and males >*18 years; • Diagnosis of multiple myeloma (NDMM patients); • Able to complete outcome measures; • Patients will be screened on minimal digital skills to check if they are able to interact with an e-coach and whether they can read and understand the Dutch language; estimated by the patient*s haematologist/oncologist • Patients have their own mobile (smart)phone, computer or tablet (20 iPads are available for exceptions) • Every new diagnosed multiple myeloma patient qualifies for study participation.

Exclusion criteria

Exclusion criteria: potential subject who meets any of the following criteria will be excluded from participation in this study: • Not prescribed oral medication for a MM treatment regime; • Psychiatric illness requiring secondary care intervention; • Too ill to engage with the intervention in the opinion of the clinical care team.

Design outcomes

Primary

MeasureTime frame
Primary hypothesis We hypothesize that implementation of the e-coach MM will result in: -Improved treatment compliance of minimum 10 percent by pill count after 3 months

Secondary

MeasureTime frame
Secondary hypotheses -Improved compliance by pill count after 12 months -Medication persistence after 12 months -Improved Quality of Life after 12 months (time to 10 point change will also be estimated and compared.) -Improved Shared Decision Making after 12 months Other explorative parameters -Reduced hospital costs related to the treatment of MM -Reduced adverse events (grade III-IV) -Improved PFS and OS -Examine the consistency of the e-coach across the subgroups (FIT and NOT FIT).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)