NCT Number: NCT07807332
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Kuala Terengganu, Terengganu, 21400, Malaysia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
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.
Time frame: From initiation of recruitment until completion of recruitment
Number and proportion of eligible caregivers who consented to participate in the study.
Time frame: Months 1, 2, and 3 after baseline
Proportion of enrolled participants who completed the scheduled follow-up assessments.
Time frame: Baseline and Months 1, 2, and 3
Proportion of participants who completed the scheduled outcome assessments.
Time frame: Baseline, Month 1, Month 2, and Month 3
Caregiver burden assessed using the Malay Zarit Burden Interview (MZBI).
Time frame: Baseline, Month 1, Month 2, and Month 3
Quality of life assessed using the Malay WHOQOL-BREF.
Time frame: Baseline, Month 1, Month 2, and Month 3
Psychological well-being assessed using the Depression Anxiety and Stress Scale-21 (DASS-21).
Clinical Research Centre, Malaysia
Other
Supporting Stroke Caregivers With the CaknaStrok Education Package: A Feasibility Cluster Randomized Controlled Trial
Acronym: CaknaStrok
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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