Increase Understanding and Safety of Treatment

NCT05242341 | Unknown

• 1 other identifier: 202106191RINA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematology; Oncology

Keywords

randomized controlled trial; application(APP); My health bank

Outcome Measures

Primary Outcomes (1)

• Drug safety and knowledge of diseases and app satisfaction

  The Questionnaire include two scale, the first one is the scale of drug safety and knowledge of diseases , the minimum score is 8 points and the maximum is 40 points, higher scores mean a better outcome; the second scale is for app satisfaction, the minimum score is 0 point and the maximum is 55 points, higher scores mean a better outcome.

  2 months

Study Arms (2)

app use teaching

EXPERIMENTAL

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).

Behavioral: application(APP) teaching

B

NO INTERVENTION

will receive pre- and post-evaluations, including knowledge of the disease, understanding of lab data, and knowledge of medication safety

Interventions

application(APP) teaching BEHAVIORAL

Teaching the use of the APP

app use teaching

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Jung Chen Chang

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Hsuan Cheng

CONTACT

(+886)988085210; ann3032004@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2021
• First Posted: February 16, 2022
• Study Start: January 14, 2022
• Primary Completion: December 31, 2022
• Study Completion: August 31, 2023
• Last Updated: March 4, 2022

Record last verified: 2022-02

Locations

TW (1)