An interventional study of CaknaStrok Education Package (CEP) in Stroke, Caregiving Burden and Caregiver, sponsored by Clinical Research Centre, Malaysia. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Clinical Research Centre, Malaysia · Not applicable, Interventional, and Other
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 113 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Clinical Research Centre, Malaysia is the lead sponsor of 30 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: CaknaStrok Education Package (CEP)
Participants received the usual stroke care and caregiver education provided as part of routine clinical practice, without the CaknaStrok Education Package.
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.
Recruitment Rate
Number and proportion of eligible caregivers who consented to participate in the study.
Time frame: From initiation of recruitment until completion of recruitment
Participant Retention Rate
Proportion of enrolled participants who completed the scheduled follow-up assessments.
Time frame: Months 1, 2, and 3 after baseline
Outcome Measure Completion Rate
Proportion of participants who completed the scheduled outcome assessments.
Time frame: Baseline and Months 1, 2, and 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).
Time frame: 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.
Time frame: 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).
Time frame: Baseline, Month 1, Month 2, and Month 3
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant-level data will not be shared to protect participant confidentiality and comply with applicable data protection and ethical requirements.
Ran from Oct 2024 to primary completion in May 2025, 7 months.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 7 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Clinical Research Centre, Malaysia