Traumatic Brain InjuryNCT05951335
m-Health Supportive Care Transition Program in Improving Post-Discharged Outcomes
A study testing m-Health Transition Care Program in people with Traumatic Brain Injury and Caregiver Burden, run by Prince of Songkla University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Caregiver Burden, Stress
- What is being tested?
- m-Health Transition Care Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of m-Health Supportive Care Transition Program in Improving Post-Discharged Outcomes Among Traumatic Brain Injury Caregivers: A Randomized Controlled Trial
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
Read more
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]
Read the 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.
- Conditions
- Traumatic Brain Injury, Caregiver Burden, Stress
- Being tested
- m-Health Transition Care Program
- Keywords
- m-health, Burden, Stress transition, Transitional care
- Medical subject headings
- Brain Injuries, Traumatic, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
m-Health Transition Care ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Other: m-Health Transition Care Program |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
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.
Measured: 5 weeks
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.
Measured: 5 weeks
Secondary outcomes (1)
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
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amelia Ganefianty, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951335
- Sponsor's protocol ID
- AG2023
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of m-Health Supportive Care Transition Program in Improving Post-Discharged Outcomes Among Traumatic Brain Injury Caregivers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05951335
- Acronym / sponsor ID
- AG2023
- Conditions
- Traumatic Brain Injury, Caregiver Burden, Stress
- Keywords
- m-health, Burden, Stress transition, Transitional care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: m-Health Transition Care ProgramThe 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| m-Health Transition Care ProgramThe 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. | Other | Intervention group |
Primary outcome
Readiness of hospital discharge used The Preparedness for Caregiving Scale (CPS)
Time frame: 5 weeks
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
Time frame: 5 weeks
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)
Time frame: 5 weeks
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.
1 secondary outcome
Readmission rate used hospital's medical record database
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing m-Health Transition Care Program in people with Traumatic Brain Injury and Caregiver Burden, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readiness of hospital discharge used The Preparedness for Caregiving Scale (CPS) (time frame: 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.