Digital Health, Health Education, Venous Thromboembolism
Conditions
Keywords
Venous Thromboembolism, Mobile Health, Prophylaxis, Health Education
Brief summary
Smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. These technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. They are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention. The objective of this study is to evaluate the impact of mobile venous thromboembolism application (mVTEA) based patient-centered management of venous thromboembolism (VTE) on patients' perceptions of thromboprophylaxis, in order to enhance clinical practice and establish a foundation of evidence for managing patients with VTE.
Interventions
mVTEA will assist in the management of patients during the post-hospitalization follow-up phase. The mVTEA's doctor terminal automatically sends VTE-related health education materials in different frequencies and contents based on the patient's knowledge of VTE prevention and treatment, as well as their risk of thrombosis and bleeding during follow-up. In addition, thrombosis physicians on the mVTEA's doctor terminal can deliver health education to patients based on their condition. This can be done through the mVTEA doctor-patient communication module, which includes text, photo, and voice interactions.
Sponsors
Navy General Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inpatients ≥18 years of age at admission; * Previous or current definitive diagnosis of DVT and/or PE by imaging, or at high risk of VTE at discharge: Padua score ≥4 for medical patients and Caprini score ≥5 for surgical patients. * Signed informed consent
Exclusion criteria
* Mental disorder or combination of other serious diseases leading to incapacity for independent living; * Inability to use smartphones, computer tablets and other smart devices; * Being pregnant or breastfeeding; * Have participated in similar trials or are undergoing other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VTE-KAP questionnaire score | The third month after discharge from the hospital | The VTE-KAP questionnaire is a self-administered questionnaire that includes demographic characteristics, knowledge, attitude, and practice (KAP) of patients towards VTE prevention and treatment. The VTE-KAP questionnaire consists of a total of 53 questions with an overall score range of 41 to 283. The higher the score, the higher the level of knowledge, attitude, and practice. The VTE-KAP questionnaire scores will be evaluated at the third-month follow-up after discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generic quality of life | The third month after discharge from the hospital | Generic, non-disease-specific health-related quality of life (QoL) is assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire and its corresponding visual analogue scale at the third-month follow-up after discharge. Briefly, the EQ-5D-5L generates an overall index that ranges from 0 (lowest generic QoL) to 1 (highest generic QoL) and is calculated based on country-specific reference value sets. The EQ-5D-5L health index was calculated with the value set for China. The EuroQol visual analogue scale ranges from 0 to 100, with higher scores indicating better health. |
| VTE events | 3 months after discharge | VTE events will be documented during the 3-month follow-up after discharge. VTE events are categorized into three groups: new-onset VTE, hospital-acquired VTE (HA-VTE), and recurrent VTE. VTE that occurred for the first time during the study period, including deep vein thrombosis (DVT) and pulmonary embolism (PE), is classified as new-onset VTE. HA-VTE is defined as any new-onset VTE that has occurred within 90 days of hospital discharge. Recurrent VTE is defined as the appearance of new evidence of VTE after acute VTE has been treated in the acute phase (2 weeks) with significant clinical improvement in signs and symptoms. According to the time of VTE recurrence, it is further categorized into early VTE recurrence (within 3 months after the last VTE occurrence) and late VTE recurrence (more than 3 months after the last VTE occurrence). |
| Chronic thromboembolic pulmonary hypertension (CTEPH) | The third month after discharge | The diagnosis of CTEPH will be documented at the third-month follow-up after discharge. |
| Chronic thromboembolic pulmonary disease (CTEPD) | The third month after discharge | The diagnosis of CTEPD will be documented at the third-month follow-up after discharge. |
| Post-pulmonary embolism syndrome (PPES) | The third month after discharge | The diagnosis of PPES will be documented at the third-month follow-up after discharge. |
| Knowledge, attitude, and practice scores in the VTE-KAP questionnaire | The third month after discharge from the hospital | The knowledge domain contains 7 questions to assess patients' levels of knowledge regarding VTE prevention and treatment. The total score of knowledge for each study participant ranged from 7 to 53. The attitude domain contains 20 questions to assess patients' attitudes towards VTE prevention and treatment. Each question was scored and the final attitude score ranged between 20 and 100. The practice domain contained 26 questions with a score range of 21 to 130 for assessing the implementation of VTE prevention and treatment behaviors in the study patients. The higher the score, the higher the level of knowledge, attitude and practice. The patients' knowledge, attitude, and practice scores in the VTE-KAP questionnaire will be assessed at the third-month follow-up after discharge separately. |
| VTE-related hospitalization | 3 months after discharge | Hospitalization due to the new-onset DVT and/or PE will be documented during the 3-month follow-up after discharge. |
| VTE-related rehospitalization | 3 months after discharge | Rehospitalization due to VTE recurrence, progression, or complications related to VTE treatment will be documented during the 3-month follow-up after discharge. |
| New-onset of atrial fibrillation or atrial flutter | 3 months after discharge | The new-onset of atrial fibrillation or atrial flutter will be documented during the 3-month follow-up after discharge. |
| Death | 3 months after discharge | Death will be documented during the 3-month follow-up after discharge. It is categorized into all-cause death and PE-related death. All-cause death is defined as death that occurs during the study period, regardless of cause.PE-related death is defined as death that is unequivocally due to PE. |
| Major bleeding | 3 months after discharge | The major bleeding events as defined by the International Society on Thrombosis and Hemostasis (ISTH) will be documented during the 3-month follow-up after discharge. |
Countries
China
Outcome results
None listed