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

NCT05951335 | Completed DMC

• 1 other identifier: AG2023
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Conditions

Traumatic Brain Injury; Caregiver Burden; Stress

Keywords

m-health; Burden; Stress transition; Transitional care

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  5 weeks

Secondary Outcomes (1)

• Readmission rate used hospital's medical record database

  5 weeks

Study Arms (2)

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.

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.

Interventions

m-Health Transition Care Program OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Amelia Ganefianty

Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 19, 2023
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)