A randomized controlled trial on the effectiveness of Brain Injury Family Intervention (BIFI) in improving psychological well-being of Traumatic Brain Injury (TBI) caregivers at two government hospitals in Malaysia
To assess the effectiveness of Brain Injury Family Intervention (BIFI) in reducing emotional distress, reducing burden of care, fulfilling caregiver’s needs, and increasing life satisfaction among Traumatic Brain Injury (TBI) caregivers in selected government hospitals.
Design
Single blinded two armed group randomized controlled trial with 100 participants from 2 government hospitals.Self-reported questionnaires will be collected at baseline, immediately after intervention program, 3 months and 6 months follow-up.
Settings and conduct
It will be conducted at Sungai Buloh Hospital and Cheras Rehabilitation Centre in Malaysia.Randomization of participants will be done using a computer generated sets of random allocation. Only investigator knows which treatment will be allocated to the groups.
Participants/Inclusion and exclusion criteria
Traumatic Brain Injury (TBI) caregivers must be Malaysian or Permanent Resident of Malaysia. Their age must be 18 and above to be eligible to participate. Traumatic Brain Injury (TBI) caregivers with any type of races/ethnicity (Malay, Chinese, Indian and others) and gender will be included. The participants must be able to read or write in Bahasa Malaysia or English. Participants could be parents, spouses, siblings, sons/daughters or relatives. They must have been caring for Traumatic Brain Injury (TBI) patients for > 3 month post injury, time spend for caring activities is at least 2 hours per day.
The exclusion criteria include paid caregiver. The injury which is not due to Traumatic Brain Injury (TBI) will be excluded.
Intervention groups
The intervention group will be involve in Brain Injury Intervention Program (BIFI) program. It is scheduled for 5 sessions in 5 weeks.Each session will take about 90 – 120 minutes.
Main outcome variables
The primary end-point is the Traumatic Brain Injury (TBI) caregiver’s emotional distress.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180809040746N1
Registration date:2018-09-01, 1397/06/10
Registration timing:prospective
Last update:2018-09-01, 1397/06/10
Update count:0
Registration date
2018-09-01, 1397/06/10
Registrant information
Name
Siti Aminah Omar
Name of organization / entity
The Universiti Teknologi MARA
Country
Malaysia
Phone
+60 3-6126 7206
Email address
siti_aminah@salam.uitm.edu.my
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2639-11-22, 2018/09/01
Expected recruitment end date
2640-11-22, 2019/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized controlled trial on the effectiveness of Brain Injury Family Intervention (BIFI) in improving psychological well-being of Traumatic Brain Injury (TBI) caregivers at two government hospitals in Malaysia
Public title
The effectiveness of Brain Injury Family Intervention (BIFI) in improving psychological well-being of Traumatic Brain Injury (TBI) caregivers at two government hospitals in Malaysia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
TBI caregivers must be Malaysian or Permanent Resident of Malaysia.
TBI caregivers with any type of races/ethnicity (Malay, Chinese, Indian and others)
Participants could be parents, spouses, siblings, sons/daughters or relatives.
The participants must be able to read or write in Bahasa Malaysia or English.
The caregivers must have been caring for TBI patients for > 3 month post injury.
Time spend for caring activities is at least 2 hours per day.
Exclusion criteria:
The exclusion criteria include paid caregiver or formal caregiver.
The injury which is not due to TBI will be excluded.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of participants will be done using a computer generated sets of random allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blind RCT will be implemented where only principle investigator knows which treatment will be allocated to the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Medical Research Register of Ministry of Health Malaysia
Street address
Jalan Rumah Sakit
City
Bangsar
Postal code
59000
Approval date
2639-11-21, 2018/08/30
Ethics committee reference number
42951
Health conditions studied
1
Description of health condition studied
Traumatic brain Injury (TBI) caregivers
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
2
Description of health condition studied
Traumatic Brain Injury caregivers
ICD-10 code
S01
ICD-10 code description
Open wound of head
3
Description of health condition studied
Traumatic Brain Injury caregivers
ICD-10 code
S06.3
ICD-10 code description
Focal traumatic brain injury
4
Description of health condition studied
Traumatic Brain Injury caregivers
ICD-10 code
S07
ICD-10 code description
Crushing injury of head
Primary outcomes
1
Description
Emotional distress
Timepoint
Baseline, immediately after intervention program, 3 months and 6 months follow-up
Method of measurement
Beck Depression Inventory, Positive and Negative Affect Schedule
Secondary outcomes
1
Description
TBI caregiver's burden level
Timepoint
Baseline, immediately after intervention program, 3 months and 6 months follow-up
Method of measurement
Caregiver Strain Index
2
Description
TBI caregiver's needs
Timepoint
Baseline, immediately after intervention program, 3 months and 6 months follow-up
Method of measurement
Family Needs Questionnaire
3
Description
TBI caregiver's life satisfaction
Timepoint
Baseline, immediately after intervention program, 3 months and 6 months follow-up
Method of measurement
Satisfaction With Life Scale
Intervention groups
1
Description
Intervention group: The participants will be involved in BIFI program and also treatment as usual (TAU). It will be scheduled for 5 sessions in 5 weeks. Each session will take for about 90 – 120 minutes
Category
Behavior
2
Description
Control group: Participants will receive Treatment -As-Usual (TAU) at their respective hospitals
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Rehabilitasi Cheras
Full name of responsible person
Dr Norazlina Abd Aziz
Street address
Jalan Yaacob Latif
City
Cheras
Postal code
56000
Phone
+60 3-9145 3400
Email
abdulaziznorazlina@yahoo.com
Web page address
http://www.hrc.moh.gov.my
2
Recruitment center
Name of recruitment center
Hospital Sungai Buloh
Full name of responsible person
Dr Akmal Hafizah Zamli
Street address
Jalan Hospital
City
Sungai Buloh
Postal code
47000
Phone
+60 3-6145 4333
Email
dr.akmal@moh.gov.my
Web page address
http://hsgbuloh.moh.gov.my/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Universiti Teknologi MARA
Full name of responsible person
Dean of Faculty of Medicine
Street address
Jalan Hospital
City
Sungai Buloh
Postal code
47000
Phone
+60 3-6126 7001
Email
zamrin7680@salam.uitm.edu.my
Web page address
https://medicine.uitm.edu.my
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Universiti Teknologi MARA
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Universiti Teknologi MARA
Full name of responsible person
Siti Aminah Omar
Position
Lecturer/ Clinical Psychologist
Latest degree
Master
Other areas of specialty/work
Clinical Psychology
Street address
Jalan Hospital
City
Sungai Buloh
Province
Selangor
Postal code
47000
Phone
+60 3-6126 7206
Email
city_min@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Universiti Teknologi MARA
Full name of responsible person
Siti Aminah Omar
Position
Lecturer/clinical psychologist
Latest degree
Master
Other areas of specialty/work
Clinical Psychology
Street address
Jalan Hospital
City
Sungai Buloh
Province
Selangor
Postal code
47000
Phone
+60 3-6126 7206
Email
city_min@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Universiti Teknologi MARA
Full name of responsible person
Siti Aminah Omar
Position
Lecturer/clinical psychologist
Latest degree
Master
Other areas of specialty/work
Clinical psychology
Street address
Jalan Hospital
City
Sungai Buloh
Province
Selangor
Postal code
47000
Phone
+60 3-6126 7206
Email
city_min@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available