Clinical trial NCT05242341: Increase Understanding and Safety of Treatment
Official title: A Randomized Controlled Trial to Explore Whether the Patients With Cancers on Clinical Trials Can Use the Health Insurance APP-My Health Bank to Increase Understanding and Safety of Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematology
Oncology
Keywords: randomized controlled trial
application(APP)
My health bank
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Purpose: The purpose of this study is to use a randomized controlled trial to explore whether the patients with cancers on clinical trials can use the Health Insurance APP-My Health Bank to increase understanding and safety of treatment. It is of hope that the results of this study can help confirm whether cancer patients participate in clinical trials, learn to use the " Health Insurance APP-My Health Bank ", can increase the safety of treatment, including the understanding of the disease , the understanding of the lab data, and the communication about contraindications and concurrent use of medications. The results of this research will help clinical healthcare professionals promote the use of My Health Bank, and improve the safety of clinical trials, as well as to increase the communications between patients, doctors and nurses.

Methods: In this study, cancer patients (hematology-oncology patients are the priority invitations) were invited to participate in clinical trials in the outpatient and inpatient units. After explaining that they agreed to participate in the study, they were randomlyassigned to the experimental group and the control group. Intervention includes teach the subjects one-on-one to use the "My Health Bank" for 30 minutes (such as download, register, test, find information, etc.), and provide pre-recorded 1-minute instructional videos for viewing when needed at home. The intervention group also accepts to follow the use of My Health Bank app at home every two weeks for a period of two months. Both groups will receive pre- and post-evaluations, including knowledge of the disease, understanding of lab data, and knowledge of medication safety (prohibited medicines and concomitant medications). Post-intervention, the intervention group will also be evaluated on the "Satisfaction and Quality of Technology Use" of My Health Bank APP. Data analysis is expected to adopt Intention-to-treat analysis (ITT) method to compare the differences before and after intervention between the two groups to verify teach patients the clinical feasibility of using a My Health Bank and the effect of assisting patient care.


Eligibility criteria: Inclusion Criteria:

* Over the age of 20, the subject voluntarily accepts this study and signs the consent form
* Participants in clinical trials of hematological tumor-related diseases (have been or are participating in it)
* Need to be literate and can communicate in Chinese and Taiwanese
* Have a mobile phone or electronic device to download the my health bank APP and be willing to cooperate with it for at least two months of continuous use

Exclusion Criteria:

* I have downloaded the "my health bank APP" and use well
* Cognitive impairment diseases (e.g. dementia)
* The clinical trial protocol that originally participated in that it is not allowed to articipate in other interventional studies.

Primary outcomes:
measure: Drug safety and knowledge of diseases and app satisfaction
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jung Chen Chang
role: PRINCIPAL_INVESTIGATOR
References: