StrokeCaknaStrokNCT07807332
CaknaStrok Education Package for Stroke Caregivers
A study testing CaknaStrok Education Package (CEP) in people with Stroke and Caregiving Burden, run by Clinical Research Centre, Malaysia at 1 site in Malaysia.
Trial summary
This study evaluated the feasibility and potential effectiveness of the CaknaStrok Education Package (CEP), a culturally tailored education package developed to support informal caregivers of stroke survivors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Caregiving Burden, Caregiver
- What is being tested?
- CaknaStrok Education Package (CEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2024to 31 Aug 2025
- 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
- Aged ≥18 years.
- Spouse, family member, or relative of the stroke patient.
- Informal caregiver of a patient diagnosed with acute stroke (within 14 days of stroke onset) with a Modified Rankin Scale (mRS) score of 4-5.
- Present during the patient's hospital admission.
- No prior caregiving experience before the current stroke event.
- Residing at home with the stroke patient.
Who cannot join
- Non-Malaysian/non-citizen.
- Maid, employee, or paid caregiver.
- Unavailable during the study period.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Raja Perempuan Zainab II (HRPZ), Kelantan Hospital Sultanah Nur Zahirah (HSNZ), Terengganu Hospital Seberang Jaya, Penang Hospital Umum Sarawak, Sarawak Hospital Sultanah Aminah, Johor Hospital Sungai Buloh, Selangor
Kuala Terengganu, Terengganu, 21400
About this study
Official title: Supporting Stroke Caregivers With the CaknaStrok Education Package: A Feasibility Cluster Randomized Controlled Trial
This study evaluated the feasibility and potential effectiveness of the CaknaStrok Education Package (CEP), a culturally tailored education package developed to support informal caregivers of stroke survivors. The package consists of a mobile health application and a Malay-language caregiving guidebook covering stroke knowledge, caregiving strategies, rehabilitation, nutrition, secondary prevention and caregiver self-care. The study compared caregivers receiving the CaknaStrok Education Package in addition to usual care with those receiving usual care alone. The study assessed outcomes related to caregiving burden, quality of life and psychological well-being, as well as the feasibility of implementing the intervention within routine stroke care.
Read the detailed description
The CaknaStrok Education Package (CEP) is a culturally tailored, blended digital and print educational intervention developed to support informal caregivers of stroke survivors in Malaysia. The intervention consists of the CaknaStrok mobile application and a Malay-language caregiving guidebook. The mobile application provides video-based caregiving guidance, stress self-assessment, Barthel Index tracking, stroke-related resources and communication with the research team. The guidebook consists of six modules covering stroke knowledge, caregiving strategies, rehabilitation exercises, nutrition, secondary prevention and caregiver self-care.
This study adopted a feasibility cluster randomized trial design and was conducted at six hospitals representing different regions of Malaysia: Hospital Raja Perempuan Zainab II, Hospital Sultanah Nur Zahirah, Hospital Seberang Jaya, Hospital Umum Sarawak, Hospital Sultanah Aminah and Hospital Sungai Buloh. The study was conducted from 1 October 2024 to 31 August 2025.
Informal caregivers of stroke survivors were recruited during the patients' hospital admission. Eligible caregivers were adults aged 18 years or older who were spouses, family members or relatives providing informal care to stroke patients with acute stroke and a Modified Rankin Scale score of 4-5.
Participants in the intervention group received the CaknaStrok Education Package in addition to usual care, while participants in the control group received usual caregiver education provided as part of routine clinical care.
The study evaluated the feasibility of the intervention and its potential effects on caregivers' psychosocial outcomes, including caregiving burden, quality of life and psychological well-being.
- Conditions
- Stroke, Caregiving Burden, Caregiver, Caregiver Burden for Those Who Care for Adults With Impaired Functional Status, Caregiver Mental Health, Caregiver Quality of Life
- Being tested
- CaknaStrok Education Package (CEP)
- Keywords
- Stroke, Stroke caregivers, Informal Caregivers, mHealth, Caknastrok
- Medical subject headings
- Stroke, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaknaStrok Education Package (CEP)Behavioural
The CaknaStrok Education Package (CEP) is a culturally tailored blended digital and print intervention for Malaysian stroke caregivers. It comprises a trilingual mobile application (Malay, English and Mandarin) with caregiving videos, stress self-assessment, Barthel Index tracking, stroke resources and communication with the research team, together with a Malay-language guidebook covering stroke knowledge, caregiving strategies, rehabilitation, nutrition, secondary prevention and caregiver self-care. Participants received a briefing and hands-on training for app installation and use, with technical assistance as needed, and continued access to the CEP for three months.
| Study group | Role | What they receive |
|---|---|---|
| CaknaStrok Education Package | Experimental | Participants received the CaknaStrok Education Package in addition to usual care. The package comprised the CaknaStrok mobile application and a Malay-language printed caregiving guidebook, providing education and support on stroke care, rehabilitation, nutrition, secondary prevention, and caregiver self-care. Receives: Behavioral: CaknaStrok Education Package (CEP) |
| Usual Care | No intervention | Participants received the usual stroke care and caregiver education provided as part of routine clinical practice, without the CaknaStrok Education Package. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number and proportion of eligible caregivers who consented to participate in the study.
Measured: From initiation of recruitment until completion of recruitment
Participant Retention Rate
Proportion of enrolled participants who completed the scheduled follow-up assessments.
Measured: Months 1, 2, and 3 after baseline
Outcome Measure Completion Rate
Proportion of participants who completed the scheduled outcome assessments.
Measured: Baseline and Months 1, 2, and 3
Secondary outcomes (3)
Caregiver Burden
Caregiver burden was assessed using the Malay Zarit Burden Interview (MZBI), a 22-item scale with total scores ranging from 0 to 88, with higher scores indicating greater caregiver burden (worse outcome).
Measured: Baseline, Month 1, Month 2, and Month 3
Quality of Life (WHOQOL-BREF)
Quality of life was assessed using the Malay World Health Organization Quality of Life-BREF (WHOQOL-BREF), comprising four domains: Physical Health, Psychological Health, Social Relationships, and Environment. Each domain is scored on a 0-100 scale, with higher scores indicating better quality of life.
Measured: Baseline, Month 1, Month 2, and Month 3
Psychological Well-Being
Psychological well-being was assessed using the Depression Anxiety and Stress Scale-21 (DASS-21), comprising three subscales: Depression, Anxiety, and Stress. Each subscale consists of 7 items, with scores ranging from 0 to 21 (or 0-42 when multiplied by 2), with higher scores indicating greater psychological distress (worse outcome).
Measured: Baseline, Month 1, Month 2, and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Oct 2024
- Primary completion31 May 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Model description
- Participants were assigned by cluster to either the CaknaStrok Education Package intervention group or usual care control group and followed concurrently.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Centre, Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Sains Malaysia
- Responsible party
- Principal investigator, NORSIMA NAZIFAH BINTI SIDEK, Clinical Research Centre, Malaysia
- Investigators
- KAMARUL IMRAN MUSA, PhD, Study director, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807332
- Sponsor's protocol ID
- CRCMalaysia
- Acronym
- CaknaStrok
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant-level data will not be shared to protect participant confidentiality and comply with applicable data protection and ethical requirements.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Stroke Caregivers With the CaknaStrok Education Package: A Feasibility Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07807332
- Acronym / sponsor ID
- CaknaStrok / CRCMalaysia
- Conditions
- Stroke, Caregiving Burden, Caregiver, Caregiver Burden for Those Who Care for Adults With Impaired Functional Status, Caregiver Mental Health, Caregiver Quality of Life
- Keywords
- Stroke, Stroke caregivers, Informal Caregivers, mHealth, Caknastrok
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Clinical Research Centre, MalaysiaUniversity, hospital or other
- Collaborators
- Universiti Sains Malaysia
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 8 Sep 2026 (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 study evaluated the feasibility and potential effectiveness of the CaknaStrok Education Package (CEP), a culturally tailored education package developed to support informal caregivers of stroke survivors. The package consists of a mobile health application and a Malay-language caregiving guidebook covering stroke knowledge, caregiving strategies, rehabilitation, nutrition, secondary prevention and caregiver self-care. The study compared caregivers receiving the CaknaStrok Education Package in addition to usual care with those receiving usual care alone. The study assessed outcomes related to caregiving burden, quality of life and psychological well-being, as well as the feasibility of implementing the intervention within routine stroke care.
Detailed description
The CaknaStrok Education Package (CEP) is a culturally tailored, blended digital and print educational intervention developed to support informal caregivers of stroke survivors in Malaysia. The intervention consists of the CaknaStrok mobile application and a Malay-language caregiving guidebook. The mobile application provides video-based caregiving guidance, stress self-assessment, Barthel Index tracking, stroke-related resources and communication with the research team. The guidebook consists of six modules covering stroke knowledge, caregiving strategies, rehabilitation exercises, nutrition, secondary prevention and caregiver self-care.
This study adopted a feasibility cluster randomized trial design and was conducted at six hospitals representing different regions of Malaysia: Hospital Raja Perempuan Zainab II, Hospital Sultanah Nur Zahirah, Hospital Seberang Jaya, Hospital Umum Sarawak, Hospital Sultanah Aminah and Hospital Sungai Buloh. The study was conducted from 1 October 2024 to 31 August 2025.
Informal caregivers of stroke survivors were recruited during the patients' hospital admission. Eligible caregivers were adults aged 18 years or older who were spouses, family members or relatives providing informal care to stroke patients with acute stroke and a Modified Rankin Scale score of 4-5.
Participants in the intervention group received the CaknaStrok Education Package in addition to usual care, while participants in the control group received usual caregiver education provided as part of routine clinical care.
The study evaluated the feasibility of the intervention and its potential effects on caregivers' psychosocial outcomes, including caregiving burden, quality of life and psychological well-being.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were assigned by cluster to either the CaknaStrok Education Package intervention group or usual care control group and followed concurrently.
| Arm | Type | Receives |
|---|---|---|
| CaknaStrok Education Package | Experimental | Behavioral: CaknaStrok Education Package (CEP)Participants received the CaknaStrok Education Package in addition to usual care. The package comprised the CaknaStrok mobile application and a Malay-language printed caregiving guidebook, providing education and support on stroke care, rehabilitation, nutrition, secondary prevention, and caregiver self-care. |
| Usual Care | No intervention | –Participants received the usual stroke care and caregiver education provided as part of routine clinical practice, without the CaknaStrok Education Package. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥18 years.
- Spouse, family member, or relative of the stroke patient.
- Informal caregiver of a patient diagnosed with acute stroke (within 14 days of stroke onset) with a Modified Rankin Scale (mRS) score of 4-5.
- Present during the patient's hospital admission.
- No prior caregiving experience before the current stroke event.
Key exclusion criteria (3 listed)
- Non-Malaysian/non-citizen.
- Maid, employee, or paid caregiver.
- Unavailable during the study period.
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 |
|---|---|---|
| CaknaStrok Education Package (CEP)The CaknaStrok Education Package (CEP) is a culturally tailored blended digital and print intervention for Malaysian stroke caregivers. It comprises a trilingual mobile application (Malay, English and Mandarin) with caregiving videos, stress self-assessment, Barthel Index tracking, stroke resources and communication with the research team, together with a Malay-language guidebook covering stroke knowledge, caregiving strategies, rehabilitation, nutrition, secondary prevention and caregiver self-care. Participants received a briefing and hands-on training for app installation and use, with technical assistance as needed, and continued access to the CEP for three months. | Behavioural | CaknaStrok Education Package |
Primary outcome
Recruitment Rate
Time frame: From initiation of recruitment until completion of recruitment
Number and proportion of eligible caregivers who consented to participate in the study.
Participant Retention Rate
Time frame: Months 1, 2, and 3 after baseline
Proportion of enrolled participants who completed the scheduled follow-up assessments.
Outcome Measure Completion Rate
Time frame: Baseline and Months 1, 2, and 3
Proportion of participants who completed the scheduled outcome assessments.
3 secondary outcomes
Caregiver Burden
Time frame: Baseline, Month 1, Month 2, and Month 3
Quality of Life (WHOQOL-BREF)
Time frame: Baseline, Month 1, Month 2, and Month 3
Psychological Well-Being
Time frame: Baseline, Month 1, Month 2, and Month 3
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 10 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant-level data will not be shared to protect participant confidentiality and comply with applicable data protection and ethical requirements.
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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.
KAMARUL IMRAN MUSA, PhD study director
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CaknaStrok Education Package (CEP) in people with Stroke and Caregiving Burden, run by Clinical Research Centre, Malaysia at 1 site in 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 6 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: finished, as of the sponsor's last update on 10 Sep 2026. 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 Malaysia. 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?
Recruitment Rate (time frame: From initiation of recruitment until completion of recruitment). 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 10 Sep 2026.