Effectiveness of the Digital Patient Platform CMyLife for Patients With Chronic Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Patients' experiences
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Participants in acceleration phase
- •Participants in blastcrise
- •Participants with planned pregnancy in the study period
研究组 & 干预措施
Intervention group
This arm uses the CMyLife platform for at least 6 months
干预措施: CMyLife (Other)
Control group
This arm does not use the CMyLife platform
结局指标
主要结局
Patients' experiences
时间窗: 6 months after baseline
Participants' experiences with the care and information they receive in hospitals for their CML were measured using Patient Reported Experience Measures
Quality of life of CML patients: EORTC QLQ-C30
时间窗: 6 months after baseline
Quality of life of participants was measured using the EORTC QLQ-C30
the information received by CML patients
时间窗: 6 months after baseline
To evaluate the information received by participants the EORTC QLQ-INFO25 was used
eHealth Literacy
时间窗: 6 months after baseline
Participants' ability to find and evaluate online health information was measured using the eHealth Literacy Scale
patient empowerment
时间窗: 6 months after baseline
The Patient Activation Measure was used to gain more insight into how and to what extent the participant believed that he/she is able to improve his/her own health
medication compliance
时间窗: 6 months after baseline
medication compliance of participants was measured using the Medication Adherence Rating Scale
disease (CML) specific quality of life: EORTC QLQ-CML24
时间窗: 6 months after baseline
disease specific quality of life of participants was measured using the EORTC QLQ-CML24
guideline adherence
时间窗: 6 months after baseline
guideline adherence was measured using the frequency of BCR-ABL1 value checks
the information received by CML patients
时间窗: at baseline
To evaluate the information received by participants the EORTC QLQ-INFO25 was used
patient empowerment
时间窗: at baseline
The Patient Activation Measure was used to gain more insight into how and to what extent the participant believed that he/she is able to improve his/her own health
eHealth Literacy
时间窗: at baseline
Participants' ability to find and evaluate online health information was measured using the eHealth Literacy Scale
medication compliance
时间窗: at baseline
medication compliance of participants was measured using the Medication Adherence Rating Scale
guideline adherence
时间窗: at baseline
guideline adherence was measured using the frequency of BCR-ABL1 value checks
Patients' experiences
时间窗: at baseline
Participants' experiences with the care and information they receive in hospitals for their CML were measured using Patient Reported Experience Measures
Quality of life of CML patients: EORTC QLQ-C30
时间窗: at baseline
Quality of life of participants was measured using the EORTC QLQ-C30
disease (CML) specific quality of life: EORTC QLQ-CML24
时间窗: at baseline
disease specific quality of life of participants was measured using the EORTC QLQ-CML24
次要结局
- Familiarity with CML related concept: tyrosine kinase inhibitor(6 months after baseline)
- Familiarity with CML related concept: BCR-ABL(6 months after baseline)
- Familiarity with CML related concept: log reduction(6 months after baseline)
- Familiarity with CML related concept: cytogenetic response/remission(6 months after baseline)
- Familiarity with CML related concept: treatment free remission(6 months after baseline)
- Familiarity with CML related concept: molecular response/remission(6 months after baseline)
- Familiarity with CML related concept: Philadelphia chromosome(6 months after baseline)
- Familiarity with CML related concept: remission(6 months after baseline)
- Familiarity with CML related concept: hematologic response/remission(6 months after baseline)
- Familiarity with CML related concept: major molecular remission(6 months after baseline)
- Familiarity with CML related concept: complete cytogenetic remission(6 months after baseline)
- Familiarity with CML related concept: Hematon(6 months after baseline)
- Familiarity with CML related concept: Philadelphia chromosome(at baseline)
- Familiarity with CML related concept: BCR-ABL(at baseline)
- Familiarity with CML related concept: tyrosine kinase inhibitor(at baseline)
- Familiarity with CML related concept: remission(at baseline)
- Familiarity with CML related concept: log reduction(at baseline)
- Familiarity with CML related concept: hematologic response/remission(at baseline)
- Familiarity with CML related concept: cytogenetic response/remission(at baseline)
- Familiarity with CML related concept: molecular response/remission(at baseline)
- Familiarity with CML related concept: major molecular remission(at baseline)
- Familiarity with CML related concept: complete cytogenetic remission(at baseline)
- Familiarity with CML related concept: treatment free remission(at baseline)
- Familiarity with CML related concept: Hematon(at baseline)