ITUMM: Telemonitoring Among Patients With Multiple Myeloma

Sponsor

Isala (Other)

Overall Status

Recruiting

CT.gov ID

NCT05964270

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Device: e-coach multipel myeloma (MM)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A two-arm open-label parallel-group randomized controlled trial (RCT) will be conducted at a supra regional cancer center (referred to as 'het oncologisch centrum Isala'), which provides hematology services to a population with 0.5 million adherence and a population of 1 million referral, in the Northern-East region of The Netherlands.A two-arm open-label parallel-group randomized controlled trial (RCT) will be conducted at a supra regional cancer center (referred to as 'het oncologisch centrum Isala'), which provides hematology services to a population with 0.5 million adherence and a population of 1 million referral, in the Northern-East region of The Netherlands.

Masking:

Single (Care Provider)

Masking Description:

pill count

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention group (IG) 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.	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 .
No Intervention: Control group (CG) Participants 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

Arm

Intervention/Treatment

Active Comparator: Intervention group (IG)

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.

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 .

No Intervention: Control group (CG)

Participants 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

Outcome Measures

Primary Outcome Measures

blinded primary outcome by pill count [over a time periode of 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Isala Klinieken	Zwolle	Overijssel	Netherlands	8012AB

Sponsors and Collaborators

Isala

Investigators

Principal Investigator: Job Eijsink, PharmD, Isala klinieken department clinical pharmacy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Job Eijsink, Principal Investigator, Isala

ClinicalTrials.gov Identifier:

NCT05964270

Other Study ID Numbers:

ITUMM

First Posted:

Jul 27, 2023

Last Update Posted:

Jul 27, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Job Eijsink, Principal Investigator, Isala

Value-base health care

e-coach

adherence

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of Jul 27, 2023