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m-Health Supportive Care Transition Program in Improving Post-Discharged Outcomes

Primary Purpose

Traumatic Brain Injury, Caregiver Burden, Stress

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
m-Health Transition Care Program
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Traumatic Brain Injury focused on measuring m-health, Burden, Stress transition, Transitional care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Amelia Ganefianty

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

The group who received The m-Health supportive care transition program consists of education and providing face-to-face information assisted by an android-based application that can access via a smartphone, skill demonstration, assessment of the readiness of hospital discharge, as well as weekly monitoring and follow-up after the patient is discharged from the hospital. This application provides education and information on TBI caregivers regarding (a) how to treat patients with TBI at home, which includes 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.

The group who received the usual care from nurses for the caregiver-patient with TBI in the ward before discharge from the hospital consists of education about physical health and TBI medical problems and how to treat TBI patients at home. This includes wound care education, medication administration, and schedule control at the hospital after patients with TBI go home. After discharge, there is no program carried out by nurses.

Outcomes

Primary Outcome Measures

Readiness of hospital discharge used The Preparedness for Caregiving Scale (CPS)
the state and process of caregivers for patients with TBI who are characterized by physical stability and competence to manage the care of patients with TBI at home, adequate support for coping after leaving the hospital, psychological ability to care for patients at home, and having sufficient information and knowledge. to address common problems in patients with TBI. There are 8 question items. Responses are rated on a 5 point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. If the total score is less than 16, it is indicated that the caregiver is not ready for hospital discharge. Still conversely, if the total score is more than 16, the caregiver is ready for hospital discharge.
Stress transition used the Caregiver Stress Self-Assessment
as a demand in which TBI caregivers do not have automatic adaptive responses when facing phases of care for patients with TBI in different settings, from hospital to home. Questionnaire containing a list of 20 statements. After each statement, indicate how often you feel that way: never, rarely, sometimes, quite frequently, or nearly always. The answer scores are Never = 0, Rarely = 1, Sometimes = 2, Quite Frequently = 3 Nearly always = 4. Total scores will be summary.
Caregiver burden used the Short- Zarit Burden Interview (ZBI)
the level of multifaceted tension felt by caregivers caring for patients with TBI at home after discharge from the hospital, related to caregiver health, psychological well-being, finances, social presence, and relationships between caregivers and patients. The Short- Zarit Burden Interview (ZBI) is a 12-item instrument for measuring the caregiver's perceived burden of providing family care. The 12 items are assessed on a 5-factor Likert scale. Items 1 to ten have positive statements so that the value ranges from 0 = 'never' to 4 = 'nearly continually.' While items number 11 and 12 have negative questions, the value ranges from 0 = 'nearly continually' to 4 = 'never. ' Item ratings are introduced to give a complete rating ranging from 0 to 48, with higher scores indicating extra burden.

Secondary Outcome Measures

Readmission rate used hospital's medical record database
the subsequent inpatient admission of a patient with TBI to an acute care facility at least 30 days after discharge of the date of discharge from the hospital

Full Information

First Posted
July 3, 2023
Last Updated
July 10, 2023
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT05951335
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Compare the response patterns (transition stress and the burden of caregiving) of TBI caregivers before and after receiving the program within the group. Compare TBI caregivers' response patterns (transition stress and the burden of caregiving) between the control and intervention groups. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Caregiver Burden, Stress
Keywords
m-health, Burden, Stress transition, Transitional care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Outcomes Assessor
Masking Description
In this study, the coding process and statistical analysis will carry out by third parties (statisticians) to reduce bias in the results and conflicts of interest.
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The group who received The m-Health supportive care transition program consists of education and providing face-to-face information assisted by an android-based application that can access via a smartphone, skill demonstration, assessment of the readiness of hospital discharge, as well as weekly monitoring and follow-up after the patient is discharged from the hospital. This application provides education and information on TBI caregivers regarding (a) how to treat patients with TBI at home, which includes 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The group who received the usual care from nurses for the caregiver-patient with TBI in the ward before discharge from the hospital consists of education about physical health and TBI medical problems and how to treat TBI patients at home. This includes wound care education, medication administration, and schedule control at the hospital after patients with TBI go home. After discharge, there is no program carried out by nurses.
Intervention Type
Other
Intervention Name(s)
m-Health Transition Care Program
Intervention Description
The m-Health supportive care transition program is a routine support program for caregivers of TBI patients. This program consists of education and providing face-to-face information assisted by an android-based application that can access via a smartphone, skill demonstration, assessment of the readiness of hospital discharge, as well as weekly monitoring and follow-up after the patient is discharged from the hospital. This application provides education and information on TBI caregivers regarding (a) how to treat patients with TBI at home, which includes 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, which consists of education about physical health, TBI medical problems, and how to treat TBI patients at home.
Primary Outcome Measure Information:
Title
Readiness of hospital discharge used The Preparedness for Caregiving Scale (CPS)
Description
the state and process of caregivers for patients with TBI who are characterized by physical stability and competence to manage the care of patients with TBI at home, adequate support for coping after leaving the hospital, psychological ability to care for patients at home, and having sufficient information and knowledge. to address common problems in patients with TBI. There are 8 question items. Responses are rated on a 5 point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. If the total score is less than 16, it is indicated that the caregiver is not ready for hospital discharge. Still conversely, if the total score is more than 16, the caregiver is ready for hospital discharge.
Time Frame
5 weeks
Title
Stress transition used the Caregiver Stress Self-Assessment
Description
as a demand in which TBI caregivers do not have automatic adaptive responses when facing phases of care for patients with TBI in different settings, from hospital to home. Questionnaire containing a list of 20 statements. After each statement, indicate how often you feel that way: never, rarely, sometimes, quite frequently, or nearly always. The answer scores are Never = 0, Rarely = 1, Sometimes = 2, Quite Frequently = 3 Nearly always = 4. Total scores will be summary.
Time Frame
5 weeks
Title
Caregiver burden used the Short- Zarit Burden Interview (ZBI)
Description
the level of multifaceted tension felt by caregivers caring for patients with TBI at home after discharge from the hospital, related to caregiver health, psychological well-being, finances, social presence, and relationships between caregivers and patients. The Short- Zarit Burden Interview (ZBI) is a 12-item instrument for measuring the caregiver's perceived burden of providing family care. The 12 items are assessed on a 5-factor Likert scale. Items 1 to ten have positive statements so that the value ranges from 0 = 'never' to 4 = 'nearly continually.' While items number 11 and 12 have negative questions, the value ranges from 0 = 'nearly continually' to 4 = 'never. ' Item ratings are introduced to give a complete rating ranging from 0 to 48, with higher scores indicating extra burden.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Readmission rate used hospital's medical record database
Description
the subsequent inpatient admission of a patient with TBI to an acute care facility at least 30 days after discharge of the date of discharge from the hospital
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Amelia Ganefianty
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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m-Health Supportive Care Transition Program in Improving Post-Discharged Outcomes

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