Clinical trial NCT05951335: m-Health Supportive Care Transition Program in Improving Post-Discharged Outcomes
Official title: Effectiveness of m-Health Supportive Care Transition Program in Improving Post-Discharged Outcomes Among Traumatic Brain Injury Caregivers: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Caregiver Burden
Stress
Keywords: m-health
Burden
Stress transition
Transitional care
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In cross-study, study participants will be transferred to all treatment groups (both test and reference formulations) after the study period is over. Being a collection of the same population, the advantage of the cross-study was that the patients acted as their controls.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This intervention study aims to investigate the effects of the m-Health supportive care transition program on response patterns (transition stress and the burden of caregiving) among traumatic brain injury (TBI) caregivers and patients' readmission rate one month after hospital discharge. Specific objectives:

1. Compare the response patterns (transition stress and the burden of caregiving) of TBI caregivers before and after receiving the program within the group.
2. Compare TBI caregivers' response patterns (transition stress and the burden of caregiving) between the control and intervention groups.
3. Compare patients' readmission rates at one month after hospital discharge between the control and intervention groups

TBI caregivers are divided into two groups: the intervention group (who receive the transitional care program) and the control group (who receive the standard care program) according to standard operating procedures applicable in the hospital.

If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\]

Detailed description: The M-health Program Application prototype concept is designed to assist the need for intervention in providing patient care during the transition of patients with TBI from hospital care to home, which nurses and patients can use as users. This program begins with education and face-to-face information using flipcharts and direct demonstration skills. The application can provide an overview of interventions carried out by TBI caregivers while at home. This will later improve the quality of service in the rehabilitation of post-TBI. This application provides education and information on TBI caregivers regarding (a) how to treat patients with TBI at home, which includes craniotomy wound care and how to provide nutrition, (b) recognize signs of infection in wounds of craniotomy, (c) recognize emergencies in cases of TBI patients at home, (d) stress management, and (e) how to arrange a schedule for the care of patients with TBI at home. This program complements routine care, including education about physical health, TBI medical problems, and how to treat TBI patients at home.

When patients with TBI are still being treated at the hospital, researchers will directly educate TBI caregivers about the components contained in m-Health. M-Health is a caregiver-assisting tool in remembering educational materials provided by researchers while in the hospital so that TBI caregivers can access educational materials quickly accompanied by educational videos that can make it easier for them to treat patients with TBI at home. There is also an online chat service within m health that allows direct chat communication between researchers and caregivers at home and can facilitate researchers in ensuring that caregivers use m-health at home. There is also a feature that provides a contact number that can be contacted when the caregiver has problems or needs assistance in caring for patients at home.

The m-Health program is also accompanied by monitoring and follow-up telephones to support TBI caregivers and assist in solving TBI caregivers' problems during the transition from hospital to home. M-health Program Application is run using an Android-based operating system. Android is software used by mobile devices that includes an operating system, middleware, and critical applications. Application development on the Android platform uses the Framework Flutter programming language. In addition, Android relies on Linux version 2.6 for core system services such as security, memory management, process management, network stack, and driver models. The kernel also acts as an abstraction layer between the hardware and the rest of the software stack.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Family members who identify themselves as responsible persons in caring for patients at home or primary caregivers who other family members have assigned to care for patients
* Caregivers who provide care for patients with moderate or severe traumatic brain injury (TBI)
* Able to communicate, read, write, and speak Indonesian well
* Willing to be involved in research; Have an Android phone and can operate it well
* Has a measurement score of The Preparedness for Caregiving Scale (PCS) \<16

Exclusion Criteria:

* Caregivers for patients with TBI with comorbidity (heart disorders, kidney disorders, and diabetes mellitus).
* Caregivers for TBI patients who will move locations outside of West Java Province after hospitalization or are sick at the hospital also not be included in this study.

Primary outcomes:
measure: Readiness of hospital discharge used The Preparedness for Caregiving Scale (CPS)
timeFrame: 5 weeks
measure: Stress transition used the Caregiver Stress Self-Assessment
timeFrame: 5 weeks
measure: Caregiver burden used the Short- Zarit Burden Interview (ZBI)
timeFrame: 5 weeks
Secondary outcomes:
measure: Readmission rate used hospital's medical record database
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Songkhla
country: Thailand
facility: Amelia Ganefianty
Study officials:
References: