Caregiver, Caregiver Burden, Caregiver Burden for Those Who Care for Adults With Impaired Functional Status, Caregiver Mental Health, Caregiver Participation, Caregiver Quality of Life, Caregiving Burden, mHealth, mHealth Intervention, Stroke
Conditions
Keywords
Stroke, Stroke caregivers, Informal Caregivers, mHealth, Caknastrok
Brief 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. 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.
Interventions
BEHAVIORALCaknaStrok 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.
Sponsors
Clinical Research Centre, Malaysia
Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants were assigned by cluster to either the CaknaStrok Education Package intervention group or usual care control group and followed concurrently.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
* Non-Malaysian/non-citizen. * Maid, employee, or paid caregiver. * Unavailable during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | From initiation of recruitment until completion of recruitment | Number and proportion of eligible caregivers who consented to participate in the study. |
| Participant Retention Rate | Months 1, 2, and 3 after baseline | Proportion of enrolled participants who completed the scheduled follow-up assessments. |
| Outcome Measure Completion Rate | Baseline and Months 1, 2, and 3 | Proportion of participants who completed the scheduled outcome assessments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Burden | Baseline, Month 1, Month 2, and Month 3 | 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). |
| Quality of Life (WHOQOL-BREF) | Baseline, Month 1, Month 2, and Month 3 | 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. |
| Psychological Well-Being | Baseline, Month 1, Month 2, and Month 3 | 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). |
Countries
Malaysia
Contacts
STUDY_DIRECTORKAMARUL IMRAN MUSA, PhD
Universiti Sains Malaysia
Outcome results
None listed