Telephone delivered intervention for family caregivers of persons with dementia in Malaysia
| ISRCTN | ISRCTN14565552 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14565552 |
| Secondary identifying numbers | FRGS21-210-0819 |
- Submission date
- 20/09/2023
- Registration date
- 23/09/2023
- Last edited
- 06/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Family caregivers of persons with dementia (PWD) are at heightened risk for emotional and mental health problems. While there are ample effective telephone-delivered approaches to address the negative effects of dementia caregiving practised in Western countries, they are lacking in Malaysia. This study assesses the efficacy of a telephone-delivered psychoeducational intervention given by occupational therapists on the reduction of caregiving burden, depressive and anxiety symptoms, and enhancement of caregiving self-efficacy and caregiver’s quality of life in family caregivers of PWD.
Who can participate?
Family caregivers of PWD who are in a caregiving role for at least 4 hrs/day for >6 months and primary caregivers, aged 18 to 64 years old
What does the study involve?
This study develops an invaluable and novel model of psychoeducational intervention in a Malaysian context for family caregivers of persons with dementia. The psychoeducation intervention will be compared with the usual care currently available in psychiatric clinics. This usual care is clinic-based and does not address the specific needs of informal dementia caregivers in the community. However, the psychoeducational intervention based on cognitive behavioural therapy, developed according to the specific needs of the homebound dementia caregivers, is delivered by trained nurses or occupational therapists over the phone for 10 sessions. A total of 121 family caregivers (60 in each arm) will participate in this study. After recruitment, all are assessed for the baseline measurements. After baseline assessment, participants will be randomly allocated into intervention and control groups. The intervention group receives the psychoeducation intervention over 12 weeks and the control group receives the usual care that is available at the government hospitals. Each participant is expected to participate in the study including the baseline and post-intervention assessment for approximately 16 weeks (12 weeks for intervention ± 4 weeks for assessments).
What are the possible benefits and risks of participating?
Through participation in this research, participants should have the following benefits: any care-related stress and burden is expected to be reduced and thereby the quality of life and caregiving self-efficacy might be improved.
There are no potential risks with the proposed psychoeducation intervention in participants’ lives as the psychoeducation intervention has already been proven beneficial in Western countries as well as in Hong Kong, Taiwan and Japan. The intervention itself may introduce more stress or anxiety as it affects the participant’s schedule. However, a high dose of flexibility to adjust participants’ time for delivering the intervention and good rapport will help to minimize those risks.
Where is the study run from?
As all procedure i.e., assessment and delivering intervention has been performed over the telephone, the participants can participate in the study from their home, hospital/clinic or workplace according to a convenient time and place. The nurses/occupational therapists deliver the intervention through the telephone from their clinic. The research assistants collect the data over the phone from their office/home (weekend).
When is the study starting and how long is it expected to run for?
September 2021 to September 2024
Who is funding the study?
Ministry of Higher Education, Malaysia (FRGS/1/2021/SKK04/UIAM/02/1/0)
Who is the main contact?
Prof Hashima E Nasreen, drnasreen@iium.edu.my
Contact information
Principal Investigator
Department of Community Medicine, Faculty of Medicine
International Islamic University Malaysia
Jalan Sultan Ahmad Shah
Bandar Indera Mahkota
Kuantan, Pahang
25200
Malaysia
 ORCID ID |
0000-0002-2976-6013 |
|---|---|
| Phone | +60 9 570 4596 |
| drnasreen@iium.edu.my |
Scientific
Associate Professor of Public Health
Principal Researcher (Senior forskare)
Division of Nursing
Dept. of Neurobiology, Care Sciences and Society
Karolinska Institutet
Alfred Nobels allé 23
23300
Huddinge
141 52
Sweden
| ORCID ID |
0000-0003-0465-5701 |
|---|---|
| Phone | +46 8 52483697 |
| zarina.kabir@ki.se |
Study information
| Study design | Multicenter interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Community, Hospital, Telephone |
| Study type | Efficacy |
| Participant information sheet | 44298_PIS_v3.0_16March2022.pdf |
| Scientific title | Telephone delivered psychoeducational intervention to reduce of psychophysical burden among dementia caregivers in east and west coasts of Malaysia |
| Study acronym | TPIFCPWD |
| Study objectives | Telephone delivered psychoeducational intervention will alleviate caregiving burden, depressive symptoms, and enhance caregiving self-efficacy and caregivers’ quality of life. |
| Ethics approval(s) |
Approved 28/03/2022, Medical Research & Ethics Committee, Ministry of Health Malaysia (Jawatankuasa Etika & Penyelidikan Perubatan, Kementerian Kesihatan Malaysia) (No 1, Jalan Setia Murni U13/52, Seksyen U13, Setia Alam, Selangor, 40170 Shah Alam, Malaysia; +60333628888; mrecsec@moh.gov.my), ref: 22-00137-BUY |
| Health condition(s) or problem(s) studied | Reduction of caregiving burden, depression and anxiety, and improvement of quality of life and caregiving self-efficacy in family caregivers of persons with dementia. |
| Intervention | Participants are randomly assigned to intervention and control groups using a computerized randomization programme. The participants in the intervention group will receive the psychoeducation intervention. The psychoeducation intervention consists of 10 sessions that will be delivered by trained nurses/occupational therapists via the telephone over the period of 12 weeks. The sessions should be constructive and supportive towards everyday challenges faced by the caregivers while caring the dementia patients. Sessions may need to be divided into multiple smaller sessions depending on the accessibility and availability of both the health providers and caregivers. The psychoeducation intervention is based on cognitive behavioural therapy and i-support for dementia (WHO 2019), which provides dementia education, and emotional support, directing caregivers to appropriate resources, encouraging caregivers to attend to their own physical, emotional and social needs, and teaching strategies to cope with the ongoing problems. The intervention does not provide any case management but serves as a question-answer hotline and provides psychotherapy over the telephone. The intervention will be implemented in three stages. The initial stage involves an introduction to the educational resource material and a description of what will happen during future follow-up calls. The psychoeducation component at this stage includes reviewing information about dementia, and common psychosocial, emotional and medical effects of caregiving, such as health, functioning, mood, thinking and family life. In the second stage, follow-up telephone contacts have been conducted to identify any new problem encountered, to discuss positive or negative changes in caregivers or patients, to apply psychoeducational information for a particular situation, and to assist caregivers in solving the problems. A therapist may choose the most appropriate intervention, such as supportive approaches (empathy, normalizing, provision of information, venting) or more active strategies (bibliotherapy, interpretation, positive reframing, problem-solving, task directive). The final call addresses issues of termination by allowing caregivers to anticipate psychoeducation telephone contacts coming to an end, and encouraging reliance on the support network established during the intervention. Contrary, the control group receives the usual care provided by the State Health Department of the Ministry of Health, Malaysia. |
| Intervention type | Behavioural |
| Primary outcome measure | Caregiving burden is measured using the Malay version of the Zarit Burden Interview and depressive and anxiety symptoms are measured by the Malay version of the Hospital Anxiety and Depression Scale at baseline and post-intervention (after 12 weeks) |
| Secondary outcome measures | 1. Caregiving self-efficacy is measured using the Revised Scale for Caregiving Self-Efficacy at baseline and post-intervention (after 12 weeks of intervention) 2. Quality of life is measured using the Control, Autonomy, Self-realization and Pleasure-19 scale at baseline and post-intervention (after 12 weeks of intervention) |
| Overall study start date | 07/09/2021 |
| Completion date | 06/09/2024 |
Eligibility
| Participant type(s) | Health professional, Carer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 64 Years |
| Sex | Both |
| Target number of participants | 121 |
| Total final enrolment | 121 |
| Key inclusion criteria | 1. Family caregivers of persons with dementia who are in a caregiving role for at least 4 hrs/day for at least 6 months 2. Family caregivers aged 18 years old and above 3. Family caregivers able to read and write in Malay or English 4. Primary caregivers (if there is >1 caregiver) 5. Should have a smartphone |
| Key exclusion criteria | 1. Caregivers younger than 18 years old 2. Major acute medical illness 3. Any cognitive impairment 4. No access to a telephone |
| Date of first enrolment | 08/04/2022 |
| Date of final enrolment | 10/03/2023 |
Locations
Countries of recruitment
- Malaysia
Study participating centres
Bandar Tun Razak
Wilayah Persekutuan
Kuala Lumpur
56000 Cheras
Malaysia
Pahang
Kuantan
25100
Malaysia
Bandar Indera Mahkota
Kuantan
25200
Malaysia
Sponsor information
Government
No.2 Tower 2
Jalan P5/6
Precinct 5
Federal territory of Putrajaya
62200
Malaysia
| Phone | +603 8000 8000 |
|---|---|
| 80008000@mygcc.gov.my | |
| Website | https://www.mohe.gov.my |
"ROR" |
https://ror.org/02xvp8z16 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- MOHE
- Location
- Malaysia
Results and Publications
| Intention to publish date | 31/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in high-impact journal peer-reviewed journals. |
| IPD sharing plan | The datasets generated during and /or analysed during the current study are not expected to be available due to confidentiality issues but are available upon reasonable request from Prof Hashima E Nasreen, drnasreen@iium.edu.my. Individual participant data will be available after de-identification. The individual participant data will be shared that underlie the results reported in the particular article after de-identification. These data will be available beginning 3 months and ending 5 years following article publication and will be shared with researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. The proposal should be directed to drnasreen@iium.edu.my. To gain access, the data requestor will need to sign a data access agreement. Data will be available at the university website. Informed consent was obtained prior to interviewing the participants. When presenting or publishing the study results, participants' identities will not be revealed. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3.0 | 16/03/2022 | 22/09/2023 | No | Yes |
| Protocol file | 22/09/2023 | No | No | ||
| Interim results article | 05/08/2024 | 06/08/2024 | Yes | No |
Additional files
Editorial Notes
06/08/2024: Publication reference added.
13/12/2023: The intention to publish date was changed from 31/12/2023 to 31/03/2024.
25/09/2023: A scientific contact was added.
22/09/2023: Study's existence confirmed by the Medical Research & Ethics Committee of the Ministry of Health Malaysia.
