Caregiver BurdenNCT06003647
Educational Intervention Among Informal Caregivers of Person With Dementia
A study testing Educational Intervention in people with Caregiver Burden, run by Universiti Putra Malaysia.
Trial summary
The goal of this intervention study is to test whether the educational intervention work well or not on informal caregiver of person with dementia. The main question it aims to answer is does the educational intervention will help to reduce the caregiver burden experience by the informal caregiver. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2023to 1 Sep 2024
- 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
- Informal caregiver of person with dementia (children, children in law, grandchildren, grandchildren in law, spouses, siblings, parents).
- Age 18 years old and above.
- Able to understand, read and speak Bahasa Malaysia language
Who cannot join
- Caregiver with previous history of mental illness.
- Caregiver with physical disabilities that cause limitation in providing care for person with dementia.
- Paid informal caregiver (maid).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Educational Intervention Among Informal Caregivers of Person With Dementia in Klang Valley, Malaysia
The goal of this intervention study is to test whether the educational intervention work well or not on informal caregiver of person with dementia. The main question it aims to answer is does the educational intervention will help to reduce the caregiver burden experience by the informal caregiver.
Participants will be given an educational module and short videos that they can refer to gain more knowledge and skills in caring for the person with dementia.
Read the detailed description
Caregivers for this study will be recruited at the geriatric, neurology and, psychiatry outpatient clinic. The caregiver will be approached by the primary researcher and explained about the details of the study. The caregivers will be given the participant information sheet and if they agree to participate in the study, written informed consent will be obtained.
The researcher will then check the eligibility of the caregiver to participate. If the caregiver was eligible to participate, they will be ask to provide contact details for researcher to assign tentative date for the virtual educational session. The caregiver will be then randomly assigned to control or intervention group before the baseline data were collected. This study will use equal allocation with a ratio of one to one for each two groups. The caregiver will be randomly allocated by using permuted block randomization technique. This study will be conducted as single blind study. Only the respondents would be blinded and concealed from the group allocation.
The intervention group will be given the educational intervention which are educational module and short videos related to dementia care. After the baseline data collection, the soft copy of the educational module will be shared to the participants via WhatsApp messenger so that they can review the module before the virtual educational session. One short educational video will be then shared to all the participants through individual WhatsApp in each Wednesday of the week for 12 weeks. Each of the short video will contain subtopics of the educational module and each video will be around two to three minutes. After the video shared to the participants, they are encouraged to ask any questions related to the content of the video.
- Conditions
- Caregiver Burden
- Being tested
- Educational Intervention
- Keywords
- Informal caregiver of person with dementia, Educational intervention
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Educational module and video
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Receive normal care |
| Intervention | Experimental | Educational intervention Receives: Other: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Burden
The caregiver burden measured by using Zarit Burden Interview (ZBI). ZBI consisted of 22 items with all negative statements. The scoring will be zero for never, one for rarely, two for sometimes, three for quite frequently and four for nearly always. The scoring can be from zero to 88 with scoring of 0 to 21 little or no burden, 21 to 40 mild to moderate burden, 41 to 60 moderates to severe burden, and 61 to 88 severe burdens.
Measured: Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
Secondary outcomes (6)
Socio-demographic characteristic
To describe the characteristics (age, gender, ethnic, level of education, employment status, relationship with demented person, monthly household income) of the caregiver of person with dementia
Measured: Baseline
Caregiving characteristics
To describe the caregiving characteristics (time spent with dementia person, severity of dementia person, functional abilities of dementia person, supports group availability) of the caregiver of person with dementia
Measured: Baseline
Caregiver knowledge on dementia
Caregiver knowledge on dementia will be based on the dementia knowledge assessment scale (DKAS) which use to explore what different individuals understand about dementia by using a multi-domain measure of dementia knowledge. The scale use five answer of measurement which is false, probably false, probably true, true and I do not know. Two points of score would be given for an answer of true to a true statement and false to a false statement. One point of score would be given for an answer of probably true to a true statement and probably false to a false statement. If the respondents give an answer of true on a false statement, false on a true statement and any answer of I do not know would be given zero point. The maximum score for the DKAS is 50 points and the respondent can be categorized on having a good knowledge if they score 40 and above, moderate level of knowledge if the score 25 to 39, and poor level of knowledge if they score below than 25 points.
Measured: Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
Caregiver self-esteem
The caregiver self-esteem will be measure by using the short sense of competence questionnaire. The scale is used to measure three domains which are the caregiver consequences of involvement in care for caregiver personal life, satisfaction with one's own performance as a caregiver and satisfaction with the demented person as a recipient care. The scoring for the scale would be one for strongly agree, two for agree, three for neutral, four for disagree and five for strongly disagree for the negative statement items. The scoring will be vice versa for the positive statement item. Higher scores indicate greater levels of competence.
Measured: Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
Caregiver mastery
The caregiver mastery is measured by using the Pearlin Mastery Scale by Pearlin and Schooler which used to explore protective buffer for caregiver' mental and physical health and well-being, when facing persistent life stresses, such as economic and occupational hardships.The scale used four-point Likert scale with one for strongly disagree, two for disagree, three for agree, and four for strongly agree. Items are summed, yielding a range from 7 to 28. Higher scores indicate greater levels of mastery.
Measured: Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
Caregiver stress coping
The caregiver stress coping will be measure by using The Coping Strategy Indicator (CSI) that is used to measures coping responses to a specific stressful event. Respondents who have high scored in the problem-solving scale were not likely to seek distraction or support. High score in the social support and avoidance scale indicates that, caregivers are not likely sought for information or distraction. High score in the avoidance subscale also most commonly predictive of negative mental health outcome such as depression and anxiety.
Measured: Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start15 Dec 2023 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuraisyah Hani Binti Zulkifley, Universiti Putra Malaysia
- Investigators
- Nuraisyah Hani Zulkifley, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003647
- Sponsor's protocol ID
- NMRR-19-3298-50711
- Status last verified
- Nov 2023
- First submitted
- 7 Aug 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Intervention Among Informal Caregivers of Person With Dementia in Klang Valley, Malaysia
- ClinicalTrials.gov ID
- NCT06003647
- Acronym / sponsor ID
- NMRR-19-3298-50711
- Conditions
- Caregiver Burden
- Keywords
- Informal caregiver of person with dementia, Educational intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 15 Dec 2023 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 22 Aug 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.
The goal of this intervention study is to test whether the educational intervention work well or not on informal caregiver of person with dementia. The main question it aims to answer is does the educational intervention will help to reduce the caregiver burden experience by the informal caregiver.
Participants will be given an educational module and short videos that they can refer to gain more knowledge and skills in caring for the person with dementia.
Detailed description
Caregivers for this study will be recruited at the geriatric, neurology and, psychiatry outpatient clinic. The caregiver will be approached by the primary researcher and explained about the details of the study. The caregivers will be given the participant information sheet and if they agree to participate in the study, written informed consent will be obtained.
The researcher will then check the eligibility of the caregiver to participate. If the caregiver was eligible to participate, they will be ask to provide contact details for researcher to assign tentative date for the virtual educational session. The caregiver will be then randomly assigned to control or intervention group before the baseline data were collected. This study will use equal allocation with a ratio of one to one for each two groups. The caregiver will be randomly allocated by using permuted block randomization technique. This study will be conducted as single blind study. Only the respondents would be blinded and concealed from the group allocation.
The intervention group will be given the educational intervention which are educational module and short videos related to dementia care. After the baseline data collection, the soft copy of the educational module will be shared to the participants via WhatsApp messenger so that they can review the module before the virtual educational session. One short educational video will be then shared to all the participants through individual WhatsApp in each Wednesday of the week for 12 weeks. Each of the short video will contain subtopics of the educational module and each video will be around two to three minutes. After the video shared to the participants, they are encouraged to ask any questions related to the content of the video.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Receive normal care |
| Intervention | Experimental | Other: Educational InterventionEducational intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informal caregiver of person with dementia (children, children in law, grandchildren, grandchildren in law, spouses, siblings, parents).
- Age 18 years old and above.
- Able to understand, read and speak Bahasa Malaysia language
Key exclusion criteria (3 listed)
- Caregiver with previous history of mental illness.
- Caregiver with physical disabilities that cause limitation in providing care for person with dementia.
- Paid informal caregiver (maid).
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 |
|---|---|---|
| Educational InterventionEducational module and video | Other | Intervention |
Primary outcome
Caregiver Burden
Time frame: Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
The caregiver burden measured by using Zarit Burden Interview (ZBI). ZBI consisted of 22 items with all negative statements. The scoring will be zero for never, one for rarely, two for sometimes, three for quite frequently and four for nearly always. The scoring can be from zero to 88 with scoring of 0 to 21 little or no burden, 21 to 40 mild to moderate burden, 41 to 60 moderates to severe burden, and 61 to 88 severe burdens.
6 secondary outcomes
Socio-demographic characteristic
Time frame: Baseline
Caregiving characteristics
Time frame: Baseline
Caregiver knowledge on dementia
Time frame: Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
Caregiver self-esteem
Time frame: Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
Caregiver mastery
Time frame: Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
Caregiver stress coping
Time frame: Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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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.
Nuraisyah Hani Zulkifley principal investigator
Universiti Putra Malaysia
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Caregiver Burden, run by Universiti Putra Malaysia.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ms (+60195249479, hanizulkifley@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Burden (time frame: Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention). 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 29 Nov 2023.