Effects of a Digital Patient Platform (CMyLife) for Patients With Chronic Myeloid Leukemia (CML) on Information Provision, Patient Empowerment, Medication Compliance, Guideline Adherence and Quality of Life

NCT ID: NCT04595955

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-08-31

Brief Summary

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A controlled before-after study is performed in order to gain insights into the effectiveness of the CMyLife platform in terms of medication compliance, guideline adherence, quality of life, information provision and patient empowerment. Participants who agreed to use the CMyLife platform for at least 6 months, were enrolled in the treatment group and participants who did not agree to use the platform were enrolled in the control group. After signing informed consent, participants received a baseline questionnaire by mail. Upon completion of the baseline questionnaire, participants used (intervention group) or did not use (control group) the CMyLife platform for at least 6 months, after which they were asked to complete the post-intervention questionnaire.

Detailed Description

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Conditions

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Neoplasms Chronic Myeloid Leukemia Patient Portals Telemedicine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention group

This arm uses the CMyLife platform for at least 6 months

Group Type EXPERIMENTAL

CMyLife

Intervention Type OTHER

CMyLife is a digital patient platform for Patients With Chronic Myeloid Leukemia.

Control group

This arm does not use the CMyLife platform

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CMyLife

CMyLife is a digital patient platform for Patients With Chronic Myeloid Leukemia.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed CML patients in chronic phase CML
* Participants were treated with first or second line TKI's at the haematology department of the participating hospitals. Patients treated with second line TKI's were only allowed to participate if they switched TKI's as a result of side effects and not if they did not respond to the first line TKI

Exclusion Criteria

* Participants in acceleration phase
* Participants in blastcrise
* Participants with planned pregnancy in the study period
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Radboudumc

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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Verweij L, Ector GICG, Smit Y, van Vlijmen B, van der Reijden BA, Hermens RPMG, Blijlevens NMA. Effectiveness of digital care platform CMyLife for patients with chronic myeloid leukemia: results of a patient-preference trial. BMC Health Serv Res. 2023 Mar 8;23(1):228. doi: 10.1186/s12913-023-09153-9.

Reference Type DERIVED
PMID: 36890512 (View on PubMed)

Other Identifiers

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RU_23-08-20_LV

Identifier Type: -

Identifier Source: org_study_id

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